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Inolitazone Dihydrochloride and Paclitaxel in Treating Patients With Advanced Anaplastic Thyroid Cancer

Primary Purpose

Anaplastic Thyroid Cancer, Recurrent Thyroid Cancer

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
efatutazone
paclitaxel
Sponsored by
Alliance for Clinical Trials in Oncology
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Anaplastic Thyroid Cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers
  • Patients must have histologically or cytologically diagnosed advanced anaplastic thyroid cancer (ATC)
  • Patients must have measurable disease
  • Patients must have either metastatic (stage IVC) or locally advanced unresectable disease (stage IVB)
  • Patients should have resolution of any toxic effects of prior therapy (except alopecia) to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE), version 4.0, grade 1
  • There is no limit to the number of prior lines of treatment a patient has received
  • No treatment with chemotherapy, radiation therapy, immunotherapy, biological therapy, hormonal therapy, or other thiazolidinediones (TZDs) =< 21 days before study registration
  • No prior taxane therapy =< 6 months, except as a radiosensitizer

  • No history of the following:

    • Class III or IV congestive heart failure (CHF)
    • Grade 3 or 4 thromboembolic event =< 6 months
    • Pericardial effusion =< 12 months (any grade)
    • Pericardial involvement with tumor
    • Grade 2 or higher pleural effusion =< 6 months
  • No current symptomatic, untreated, or uncontrolled brain metastases present
  • No major surgery =< 14 days prior to registration
  • No grade 2 or higher neuropathy
  • No known history of severe hypersensitivity reactions to any of the components of efatutazone or paclitaxel formulations
  • Not pregnant and not nursing; women of childbearing potential only, a negative pregnancy test done =< 7 days prior to registration is required
  • Patients with diabetes mellitus requiring concurrent treatment with insulin or thiazolidinedione (TZD) oral agents are not eligible
  • Patients with known hypersensitivity to any TZD oral agents are not eligible
  • Eastern Cooperative Oncology Group (ECOG) performance status =< 2
  • Absolute neutrophil count (ANC) >= 1,500/mm^3
  • Platelet count >= 100,000/mm^3
  • Creatinine =< 1.5 x upper limit of normal (ULN) mg/dL OR calculated (calc.) creatinine clearance >= 60 mL/min
  • Bilirubin =< 1.5 x ULN
  • Aspartate aminotransferase (AST) =< 2.5 x ULN

  • Although they will not be considered formal eligibility (exclusion) criteria, physicians should recognize that the following may seriously increase the risk to the patient entering this protocol:

    • Psychiatric illness which would prevent the patient from giving informed consent
    • Medical condition such as uncontrolled infection (including human immunodeficiency virus [HIV]), uncontrolled diabetes mellitus or cardiac disease which, in the opinion of the treating physician, would make this protocol unreasonably hazardous for the patient
    • Patients with a "currently active" second malignancy other than non-melanoma skin cancers; patients are not considered to have a "currently active" malignancy if they have completed therapy and are free of disease for >= 3 years; there is an exception for patients with a history of well differentiated thyroid cancer that has progressed to anaplastic thyroid cancer
    • Patients who cannot swallow oral formulations of the agent(s)
    • Women and men of reproductive potential should agree to use an appropriate method of birth control throughout their participation in this study ; appropriate methods of birth control include abstinence, oral contraceptives, implantable hormonal contraceptives or double barrier method (diaphragm plus condom)
    • Efatutazone is metabolized by cytochrome P450, family 3, subfamily A, polypeptide 4/5 (CYP3A4/5), and inhibits CYP2C8, 2C9, 2C19, and 3A4, and is a substrate of P-glycoprotein (PgP) and breast cancer resistance protein (BCRP)

Sites / Locations

  • Anchorage Associates in Radiation Medicine
  • Anchorage Radiation Therapy Center
  • Alaska Breast Care and Surgery LLC
  • Alaska Oncology and Hematology LLC
  • Alaska Regional Hospital
  • Alaska Women's Cancer Care
  • Anchorage Oncology Centre
  • Katmai Oncology Group
  • Providence Alaska Medical Center
  • Mayo Clinic Hospital
  • Mayo Clinic in Arizona
  • Providence Saint Joseph Medical Center/Disney Family Cancer Center
  • University of Colorado Hospital
  • Smilow Cancer Hospital Care Center at Saint Francis
  • Smilow Cancer Center/Yale-New Haven Hospital
  • Yale University
  • Beebe Medical Center
  • Christiana Gynecologic Oncology LLC
  • Delaware Clinical and Laboratory Physicians PA
  • Helen F Graham Cancer Center
  • Medical Oncology Hematology Consultants PA
  • Regional Hematology and Oncology PA
  • Christiana Care Health System-Christiana Hospital
  • Beebe Health Campus
  • Nanticoke Memorial Hospital
  • Christiana Care Health System-Wilmington Hospital
  • Mayo Clinic in Florida
  • Hawaii Oncology Inc-Pali Momi
  • Pali Momi Medical Center
  • The Cancer Center of Hawaii-Pali Momi
  • Hawaii Cancer Care Inc-POB II
  • Queen's Medical Center
  • Straub Clinic and Hospital
  • University of Hawaii Cancer Center
  • Hawaii Cancer Care Inc-Liliha
  • Hawaii Oncology Inc-Kuakini
  • Kuakini Medical Center
  • The Cancer Center of Hawaii-Liliha
  • Kapiolani Medical Center for Women and Children
  • Wilcox Memorial Hospital and Kauai Medical Clinic
  • Saint Alphonsus Cancer Care Center-Boise
  • Saint Luke's Mountain States Tumor Institute
  • Saint Alphonsus Cancer Care Center-Caldwell
  • Kootenai Medical Center
  • Walter Knox Memorial Hospital
  • Saint Luke's Mountain States Tumor Institute - Fruitland
  • Idaho Urologic Institute-Meridian
  • Saint Luke's Mountain States Tumor Institute - Meridian
  • Saint Alphonsus Medical Center-Nampa
  • Saint Luke's Mountain States Tumor Institute - Nampa
  • Kootenai Cancer Center
  • Kootenai Cancer Clinic
  • Saint Luke's Mountain States Tumor Institute-Twin Falls
  • Northwestern University
  • Cancer Center of Kansas - Chanute
  • Cancer Center of Kansas - Dodge City
  • Cancer Center of Kansas - El Dorado
  • Cancer Center of Kansas - Fort Scott
  • Central Care Cancer Center - Garden City
  • Central Care Cancer Center - Great Bend
  • Cancer Center of Kansas-Independence
  • Cancer Center of Kansas-Kingman
  • Lawrence Memorial Hospital
  • Kansas Institute of Medicine Cancer and Blood Center
  • Minimally Invasive Surgery Hospital
  • Cancer Center of Kansas-Liberal
  • Cancer Center of Kansas-Manhattan
  • Cancer Center of Kansas - McPherson
  • Cancer Center of Kansas - Newton
  • Menorah Medical Center
  • Saint Luke's South Hospital
  • Cancer Center of Kansas - Parsons
  • Cancer Center of Kansas - Pratt
  • Cancer Center of Kansas - Salina
  • Cancer Center of Kansas - Wellington
  • Associates In Womens Health
  • Cancer Center of Kansas-Wichita Medical Arts Tower
  • Cancer Center of Kansas - Wichita
  • Via Christi Regional Medical Center
  • Cancer Center of Kansas - Winfield
  • Mercy Medical Center
  • Saint Joseph Mercy Hospital
  • University of Michigan Comprehensive Cancer Center
  • IHA Hematology Oncology Consultants-Brighton
  • Saint Joseph Mercy Brighton
  • IHA Hematology Oncology Consultants-Canton
  • Saint Joseph Mercy Canton
  • Caro Cancer Center
  • IHA Hematology Oncology Consultants-Chelsea
  • Saint Joseph Mercy Chelsea
  • Hematology Oncology Consultants-Clarkston
  • Newland Medical Associates-Clarkston
  • Beaumont Hospital-Dearborn
  • Henry Ford Hospital
  • Ascension Saint John Hospital
  • Great Lakes Cancer Management Specialists-Doctors Park
  • Genesee Cancer and Blood Disease Treatment Center
  • Genesee Hematology Oncology PC
  • Genesys Hurley Cancer Institute
  • Hurley Medical Center
  • Great Lakes Cancer Management Specialists-Van Elslander Cancer Center
  • Lymphoma Clinic of Michigan
  • Michigan Breast Specialists-Grosse Pointe Woods
  • Allegiance Health
  • Sparrow Hospital
  • Hope Cancer Clinic
  • Saint Mary Mercy Hospital
  • Great Lakes Cancer Management Specialists-Macomb Medical Campus
  • Michigan Breast Specialists-Macomb Township
  • Saint Mary's Oncology/Hematology Associates of Marlette
  • 21st Century Oncology-Pontiac
  • Hope Cancer Center
  • Newland Medical Associates-Pontiac
  • Saint Joseph Mercy Oakland
  • Lake Huron Medical Center
  • Great Lakes Cancer Management Specialists-Rochester Hills
  • Saint Mary's of Michigan
  • Oncology Hematology Associates of Saginaw Valley PC
  • Bhadresh Nayak MD PC-Sterling Heights
  • Saint Joseph Health System-Tawas City
  • Advanced Breast Care Center PLLC
  • Bhadresh Nayak MD PC-Warren
  • Great Lakes Cancer Management Specialists-Macomb Professional Building
  • Macomb Hematology Oncology PC
  • Michigan Breast Specialists-Warren
  • Saint John Macomb-Oakland Hospital
  • Saint Mary's Oncology/Hematology Associates of West Branch
  • Huron Gastroenterology PC
  • IHA Hematology Oncology Consultants-Ann Arbor
  • Sanford Joe Lueken Cancer Center
  • Fairview Ridges Hospital
  • Mercy Hospital
  • Fairview-Southdale Hospital
  • Unity Hospital
  • Fairview Maple Grove Medical Center
  • Minnesota Oncology Hematology PA-Maplewood
  • Saint John's Hospital - Healtheast
  • Abbott-Northwestern Hospital
  • Hennepin County Medical Center
  • Health Partners Inc
  • New Ulm Medical Center
  • North Memorial Medical Health Center
  • Mayo Clinic
  • Park Nicollet Clinic - Saint Louis Park
  • Regions Hospital
  • United Hospital
  • Saint Francis Regional Medical Center
  • Lakeview Hospital
  • Ridgeview Medical Center
  • Rice Memorial Hospital
  • Minnesota Oncology Hematology PA-Woodbury
  • Fairview Lakes Medical Center
  • Central Care Cancer Center - Bolivar
  • Centerpoint Medical Center LLC
  • Freeman Health System
  • Saint Luke's Hospital of Kansas City
  • Heartland Hematology and Oncology Associates Incorporated
  • Research Medical Center
  • Saint Luke's East - Lee's Summit
  • Liberty Radiation Oncology Center
  • Delbert Day Cancer Institute at PCRMC
  • Heartland Regional Medical Center
  • Saint Louis Cancer and Breast Institute-South City
  • Washington University School of Medicine
  • Mercy Hospital Saint Louis
  • Mercy Hospital Springfield
  • CoxHealth South Hospital
  • Community Hospital of Anaconda
  • Billings Clinic Cancer Center
  • Bozeman Deaconess Hospital
  • Benefis Healthcare- Sletten Cancer Institute
  • Great Falls Clinic
  • Saint Peter's Community Hospital
  • Kalispell Regional Medical Center
  • Saint Patrick Hospital - Community Hospital
  • Community Medical Hospital
  • Sanford Bismarck Medical Center
  • Roger Maris Cancer Center
  • Sanford Broadway Medical Center
  • University of Cincinnati/Barrett Cancer Center
  • Ohio State University Comprehensive Cancer Center
  • University Pointe
  • University of Oklahoma Health Sciences Center
  • Oklahoma Cancer Specialists and Research Institute-Tulsa
  • Saint Alphonsus Medical Center-Baker City
  • Saint Charles Health System
  • Clackamas Radiation Oncology Center
  • Providence Oncology and Hematology Care Southeast
  • Bay Area Hospital
  • Providence Newberg Medical Center
  • Saint Alphonsus Medical Center-Ontario
  • Providence Willamette Falls Medical Center
  • Providence Portland Medical Center
  • Providence Saint Vincent Medical Center
  • Saint Charles Health System-Redmond
  • Lehigh Valley Hospital-Cedar Crest
  • Lehigh Valley Hospital - Muhlenberg
  • Geisinger Medical Center
  • Pocono Medical Center
  • Geisinger Medical Center-Cancer Center Hazleton
  • Lehigh Valley Hospital-Hazleton
  • Geisinger Medical Oncology-Lewisburg
  • Lewistown Hospital
  • Geisinger Cancer Services-Pottsville
  • Community Medical Center
  • Geisinger Medical Oncology-Selinsgrove
  • Geisinger Medical Group
  • Geisinger Wyoming Valley/Henry Cancer Center
  • Greenville Health System Cancer Institute-Easley
  • Greenville Health System Cancer Institute-Andrews
  • Greenville Health System Cancer Institute-Butternut
  • Greenville Health System Cancer Institute-Faris
  • Greenville Memorial Hospital
  • Greenville Health System Cancer Institute-Eastside
  • Greenville Health System Cancer Institute-Greer
  • Greenville Health System Cancer Institute-Seneca
  • Greenville Health System Cancer Institute-Spartanburg
  • Sanford Cancer Center Oncology Clinic
  • Sanford USD Medical Center - Sioux Falls
  • Providence Regional Cancer System-Aberdeen
  • Cancer Care Center at Island Hospital
  • Swedish Cancer Institute-Eastside Oncology Hematology
  • PeaceHealth Saint Joseph Medical Center
  • Harrison HealthPartners Hematology and Oncology-Bremerton
  • Providence Regional Cancer System-Centralia
  • Swedish Medical Center-Edmonds
  • Providence Regional Cancer Partnership
  • Swedish Cancer Institute-Issaquah
  • Kadlec Clinic Hematology and Oncology
  • Providence Regional Cancer System-Lacey
  • PeaceHealth Saint John Medical Center
  • Jefferson Healthcare
  • Harrison HealthPartners Hematology and Oncology-Poulsbo
  • Minor and James Medical PLLC
  • Pacific Gynecology Specialists
  • Swedish Medical Center-Ballard Campus
  • Kaiser Permanente Washington
  • Swedish Medical Center-First Hill
  • Swedish Medical Center-Cherry Hill
  • PeaceHealth United General Medical Center
  • Providence Regional Cancer System-Shelton
  • Rockwood Clinic Cancer Treatment Center-Valley
  • Rockwood Cancer Treatment Center-DHEC-Downtown
  • Evergreen Hematology and Oncology PS
  • Rockwood North Cancer Treatment Center
  • PeaceHealth Southwest Medical Center
  • Providence Saint Mary Regional Cancer Center
  • North Star Lodge Cancer Center at Yakima Valley Memorial Hospital
  • Providence Regional Cancer System-Yelm
  • Froedtert and the Medical College of Wisconsin
  • Cancer Center of Western Wisconsin
  • Billings Clinic-Cody
  • Welch Cancer Center

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

efatutazone dihydrochloride, paclitaxel

Arm Description

Patients receive paclitaxel IV over 3 hours on day 1 and efatutazone dihydrochloride PO BID on days 1-21. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.

Outcomes

Primary Outcome Measures

Confirmed Response Rate (Partial Response [PR] or Complete Response [CR]) Per Response Evaluation Criteria In Solid Tumors (RECIST) 1.1 Criteria
The response rate (percentage) is the percent of patients whose best response was Complete Response (CR) or Partial Response (PR) as defined by RECIST 1.1 criteria. Percentage of successes will be estimated by 100 times the number of successes divided by the total number of evaluable patients.

Secondary Outcome Measures

Overall Survival
Overall survival time is defined as the time from randomization to death due to any cause. The median and 95% confidence intervals are estimated using the Kaplan-Meier estimator.
Duration of Confirmed Response
Duration of response is defined for all evaluable patients who have achieved a confirmed response as the date at which the patient's objective status is first noted to be a CR or PR to the earliest date progression (PD) is documented. The distribution of duration of response will be estimated using the method of Kaplan-Meier. (CR: Disappearance of all evidence of disease, PR: Regression of measurable disease and no new sites, PD: Any new lesion or increase by ≥50% of previously involved sites from nadir).
PFS Determined Based on RECIST 1.1 Criteria
Progression free survival (PFS) is defined as the time from the date of registration to the date of disease progression or death resulting from any cause, whichever comes first. Progression is defined according to Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1. The median and 95% confidence intervals are estimated using the Kaplan-Meier estimator. Progression is defined according to Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions.
Number of Patients Experiencing at Least One Grade 3+ Adverse Event Using CTCAE Version 4.0
The number of patients who experienced at least one grade 3 or higher adverse event is reported below.

Full Information

First Posted
May 29, 2014
Last Updated
April 25, 2023
Sponsor
Alliance for Clinical Trials in Oncology
Collaborators
National Cancer Institute (NCI), Daiichi Sankyo, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT02152137
Brief Title
Inolitazone Dihydrochloride and Paclitaxel in Treating Patients With Advanced Anaplastic Thyroid Cancer
Official Title
A Phase 2 Study of Efatutazone, an Oral PPAR Agonist, In Combination With Paclitaxel in Patients With Advanced Anaplastic Thyroid Cancer
Study Type
Interventional

2. Study Status

Record Verification Date
April 2023
Overall Recruitment Status
Completed
Study Start Date
September 2014 (Actual)
Primary Completion Date
February 27, 2019 (Actual)
Study Completion Date
April 15, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Alliance for Clinical Trials in Oncology
Collaborators
National Cancer Institute (NCI), Daiichi Sankyo, Inc.

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
This phase II trial studies how well inolitazone dihydrochloride (efatutazone dihydrochloride) and paclitaxel work in treating patients with anaplastic thyroid cancer that has spread to other places in the body and usually cannot be cured or controlled with treatment (advanced). Drugs used in chemotherapy, such as efatutazone dihydrochloride and paclitaxel, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading.
Detailed Description
PRIMARY OBJECTIVES: I. To determine if the combination of paclitaxel and efatutazone (efatutazone dihydrochloride) improves the confirmed response rate in patients with advanced anaplastic thyroid cancer. SECONDARY OBJECTIVES: I. To estimate the overall survival (OS), duration of response, progression-free survival (PFS), and adverse event rates for the combination of paclitaxel and efatutazone. TERTIARY OBJECTIVES: I. The association of biomarkers with clinical outcome data will be assessed in an exploratory translational analysis. OUTLINE: Patients receive paclitaxel intravenously (IV) over 3 hours on day 1 and efatutazone dihydrochloride orally (PO) twice daily (BID) on days 1-21. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed up within 28 days, every 8 weeks until disease progression, and then every 6 months for 5 years.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Anaplastic Thyroid Cancer, Recurrent Thyroid Cancer

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
19 (Actual)

8. Arms, Groups, and Interventions

Arm Title
efatutazone dihydrochloride, paclitaxel
Arm Type
Experimental
Arm Description
Patients receive paclitaxel IV over 3 hours on day 1 and efatutazone dihydrochloride PO BID on days 1-21. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
Intervention Type
Drug
Intervention Name(s)
efatutazone
Other Intervention Name(s)
CS-7017
Intervention Description
Given PO
Intervention Type
Drug
Intervention Name(s)
paclitaxel
Other Intervention Name(s)
Taxol
Intervention Description
Given IV
Primary Outcome Measure Information:
Title
Confirmed Response Rate (Partial Response [PR] or Complete Response [CR]) Per Response Evaluation Criteria In Solid Tumors (RECIST) 1.1 Criteria
Description
The response rate (percentage) is the percent of patients whose best response was Complete Response (CR) or Partial Response (PR) as defined by RECIST 1.1 criteria. Percentage of successes will be estimated by 100 times the number of successes divided by the total number of evaluable patients.
Time Frame
Up to 24 weeks
Secondary Outcome Measure Information:
Title
Overall Survival
Description
Overall survival time is defined as the time from randomization to death due to any cause. The median and 95% confidence intervals are estimated using the Kaplan-Meier estimator.
Time Frame
Time from study entry to death from any cause, assessed up to 5 years
Title
Duration of Confirmed Response
Description
Duration of response is defined for all evaluable patients who have achieved a confirmed response as the date at which the patient's objective status is first noted to be a CR or PR to the earliest date progression (PD) is documented. The distribution of duration of response will be estimated using the method of Kaplan-Meier. (CR: Disappearance of all evidence of disease, PR: Regression of measurable disease and no new sites, PD: Any new lesion or increase by ≥50% of previously involved sites from nadir).
Time Frame
The time from the first documented date of confirmed response (CR or PR) to date at which progression is first documented, assessed up to 5 years
Title
PFS Determined Based on RECIST 1.1 Criteria
Description
Progression free survival (PFS) is defined as the time from the date of registration to the date of disease progression or death resulting from any cause, whichever comes first. Progression is defined according to Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1. The median and 95% confidence intervals are estimated using the Kaplan-Meier estimator. Progression is defined according to Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions.
Time Frame
The time from study entry to the first of either disease progression or death from any cause, assessed up to 5 years
Title
Number of Patients Experiencing at Least One Grade 3+ Adverse Event Using CTCAE Version 4.0
Description
The number of patients who experienced at least one grade 3 or higher adverse event is reported below.
Time Frame
Up to 5 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Patients must have histologically or cytologically diagnosed advanced anaplastic thyroid cancer (ATC) Patients must have measurable disease Patients must have either metastatic (stage IVC) or locally advanced unresectable disease (stage IVB) Patients should have resolution of any toxic effects of prior therapy (except alopecia) to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE), version 4.0, grade 1 There is no limit to the number of prior lines of treatment a patient has received No treatment with chemotherapy, radiation therapy, immunotherapy, biological therapy, hormonal therapy, or other thiazolidinediones (TZDs) =< 21 days before study registration No prior taxane therapy =< 6 months, except as a radiosensitizer No history of the following: Class III or IV congestive heart failure (CHF) Grade 3 or 4 thromboembolic event =< 6 months Pericardial effusion =< 12 months (any grade) Pericardial involvement with tumor Grade 2 or higher pleural effusion =< 6 months No current symptomatic, untreated, or uncontrolled brain metastases present No major surgery =< 14 days prior to registration No grade 2 or higher neuropathy No known history of severe hypersensitivity reactions to any of the components of efatutazone or paclitaxel formulations Not pregnant and not nursing; women of childbearing potential only, a negative pregnancy test done =< 7 days prior to registration is required Patients with diabetes mellitus requiring concurrent treatment with insulin or thiazolidinedione (TZD) oral agents are not eligible Patients with known hypersensitivity to any TZD oral agents are not eligible Eastern Cooperative Oncology Group (ECOG) performance status =< 2 Absolute neutrophil count (ANC) >= 1,500/mm^3 Platelet count >= 100,000/mm^3 Creatinine =< 1.5 x upper limit of normal (ULN) mg/dL OR calculated (calc.) creatinine clearance >= 60 mL/min Bilirubin =< 1.5 x ULN Aspartate aminotransferase (AST) =< 2.5 x ULN Although they will not be considered formal eligibility (exclusion) criteria, physicians should recognize that the following may seriously increase the risk to the patient entering this protocol: Psychiatric illness which would prevent the patient from giving informed consent Medical condition such as uncontrolled infection (including human immunodeficiency virus [HIV]), uncontrolled diabetes mellitus or cardiac disease which, in the opinion of the treating physician, would make this protocol unreasonably hazardous for the patient Patients with a "currently active" second malignancy other than non-melanoma skin cancers; patients are not considered to have a "currently active" malignancy if they have completed therapy and are free of disease for >= 3 years; there is an exception for patients with a history of well differentiated thyroid cancer that has progressed to anaplastic thyroid cancer Patients who cannot swallow oral formulations of the agent(s) Women and men of reproductive potential should agree to use an appropriate method of birth control throughout their participation in this study ; appropriate methods of birth control include abstinence, oral contraceptives, implantable hormonal contraceptives or double barrier method (diaphragm plus condom) Efatutazone is metabolized by cytochrome P450, family 3, subfamily A, polypeptide 4/5 (CYP3A4/5), and inhibits CYP2C8, 2C9, 2C19, and 3A4, and is a substrate of P-glycoprotein (PgP) and breast cancer resistance protein (BCRP)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Robert Smallridge, M.D.
Organizational Affiliation
Mayo Clinic
Official's Role
Study Chair
Facility Information:
Facility Name
Anchorage Associates in Radiation Medicine
City
Anchorage
State/Province
Alaska
ZIP/Postal Code
98508
Country
United States
Facility Name
Anchorage Radiation Therapy Center
City
Anchorage
State/Province
Alaska
ZIP/Postal Code
99504
Country
United States
Facility Name
Alaska Breast Care and Surgery LLC
City
Anchorage
State/Province
Alaska
ZIP/Postal Code
99508
Country
United States
Facility Name
Alaska Oncology and Hematology LLC
City
Anchorage
State/Province
Alaska
ZIP/Postal Code
99508
Country
United States
Facility Name
Alaska Regional Hospital
City
Anchorage
State/Province
Alaska
ZIP/Postal Code
99508
Country
United States
Facility Name
Alaska Women's Cancer Care
City
Anchorage
State/Province
Alaska
ZIP/Postal Code
99508
Country
United States
Facility Name
Anchorage Oncology Centre
City
Anchorage
State/Province
Alaska
ZIP/Postal Code
99508
Country
United States
Facility Name
Katmai Oncology Group
City
Anchorage
State/Province
Alaska
ZIP/Postal Code
99508
Country
United States
Facility Name
Providence Alaska Medical Center
City
Anchorage
State/Province
Alaska
ZIP/Postal Code
99508
Country
United States
Facility Name
Mayo Clinic Hospital
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85054
Country
United States
Facility Name
Mayo Clinic in Arizona
City
Scottsdale
State/Province
Arizona
ZIP/Postal Code
85259
Country
United States
Facility Name
Providence Saint Joseph Medical Center/Disney Family Cancer Center
City
Burbank
State/Province
California
ZIP/Postal Code
91505
Country
United States
Facility Name
University of Colorado Hospital
City
Aurora
State/Province
Colorado
ZIP/Postal Code
80045
Country
United States
Facility Name
Smilow Cancer Hospital Care Center at Saint Francis
City
Hartford
State/Province
Connecticut
ZIP/Postal Code
06105
Country
United States
Facility Name
Smilow Cancer Center/Yale-New Haven Hospital
City
New Haven
State/Province
Connecticut
ZIP/Postal Code
06510
Country
United States
Facility Name
Yale University
City
New Haven
State/Province
Connecticut
ZIP/Postal Code
06520
Country
United States
Facility Name
Beebe Medical Center
City
Lewes
State/Province
Delaware
ZIP/Postal Code
19958
Country
United States
Facility Name
Christiana Gynecologic Oncology LLC
City
Newark
State/Province
Delaware
ZIP/Postal Code
19713
Country
United States
Facility Name
Delaware Clinical and Laboratory Physicians PA
City
Newark
State/Province
Delaware
ZIP/Postal Code
19713
Country
United States
Facility Name
Helen F Graham Cancer Center
City
Newark
State/Province
Delaware
ZIP/Postal Code
19713
Country
United States
Facility Name
Medical Oncology Hematology Consultants PA
City
Newark
State/Province
Delaware
ZIP/Postal Code
19713
Country
United States
Facility Name
Regional Hematology and Oncology PA
City
Newark
State/Province
Delaware
ZIP/Postal Code
19713
Country
United States
Facility Name
Christiana Care Health System-Christiana Hospital
City
Newark
State/Province
Delaware
ZIP/Postal Code
19718
Country
United States
Facility Name
Beebe Health Campus
City
Rehoboth Beach
State/Province
Delaware
ZIP/Postal Code
19971
Country
United States
Facility Name
Nanticoke Memorial Hospital
City
Seaford
State/Province
Delaware
ZIP/Postal Code
19973
Country
United States
Facility Name
Christiana Care Health System-Wilmington Hospital
City
Wilmington
State/Province
Delaware
ZIP/Postal Code
19801
Country
United States
Facility Name
Mayo Clinic in Florida
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32224-9980
Country
United States
Facility Name
Hawaii Oncology Inc-Pali Momi
City
'Aiea
State/Province
Hawaii
ZIP/Postal Code
96701
Country
United States
Facility Name
Pali Momi Medical Center
City
'Aiea
State/Province
Hawaii
ZIP/Postal Code
96701
Country
United States
Facility Name
The Cancer Center of Hawaii-Pali Momi
City
'Aiea
State/Province
Hawaii
ZIP/Postal Code
96701
Country
United States
Facility Name
Hawaii Cancer Care Inc-POB II
City
Honolulu
State/Province
Hawaii
ZIP/Postal Code
96813
Country
United States
Facility Name
Queen's Medical Center
City
Honolulu
State/Province
Hawaii
ZIP/Postal Code
96813
Country
United States
Facility Name
Straub Clinic and Hospital
City
Honolulu
State/Province
Hawaii
ZIP/Postal Code
96813
Country
United States
Facility Name
University of Hawaii Cancer Center
City
Honolulu
State/Province
Hawaii
ZIP/Postal Code
96813
Country
United States
Facility Name
Hawaii Cancer Care Inc-Liliha
City
Honolulu
State/Province
Hawaii
ZIP/Postal Code
96817
Country
United States
Facility Name
Hawaii Oncology Inc-Kuakini
City
Honolulu
State/Province
Hawaii
ZIP/Postal Code
96817
Country
United States
Facility Name
Kuakini Medical Center
City
Honolulu
State/Province
Hawaii
ZIP/Postal Code
96817
Country
United States
Facility Name
The Cancer Center of Hawaii-Liliha
City
Honolulu
State/Province
Hawaii
ZIP/Postal Code
96817
Country
United States
Facility Name
Kapiolani Medical Center for Women and Children
City
Honolulu
State/Province
Hawaii
ZIP/Postal Code
96826
Country
United States
Facility Name
Wilcox Memorial Hospital and Kauai Medical Clinic
City
Lihue
State/Province
Hawaii
ZIP/Postal Code
96766
Country
United States
Facility Name
Saint Alphonsus Cancer Care Center-Boise
City
Boise
State/Province
Idaho
ZIP/Postal Code
83706
Country
United States
Facility Name
Saint Luke's Mountain States Tumor Institute
City
Boise
State/Province
Idaho
ZIP/Postal Code
83712
Country
United States
Facility Name
Saint Alphonsus Cancer Care Center-Caldwell
City
Caldwell
State/Province
Idaho
ZIP/Postal Code
83605
Country
United States
Facility Name
Kootenai Medical Center
City
Coeur d'Alene
State/Province
Idaho
ZIP/Postal Code
83814
Country
United States
Facility Name
Walter Knox Memorial Hospital
City
Emmett
State/Province
Idaho
ZIP/Postal Code
83617
Country
United States
Facility Name
Saint Luke's Mountain States Tumor Institute - Fruitland
City
Fruitland
State/Province
Idaho
ZIP/Postal Code
83619
Country
United States
Facility Name
Idaho Urologic Institute-Meridian
City
Meridian
State/Province
Idaho
ZIP/Postal Code
83642
Country
United States
Facility Name
Saint Luke's Mountain States Tumor Institute - Meridian
City
Meridian
State/Province
Idaho
ZIP/Postal Code
83642
Country
United States
Facility Name
Saint Alphonsus Medical Center-Nampa
City
Nampa
State/Province
Idaho
ZIP/Postal Code
83686
Country
United States
Facility Name
Saint Luke's Mountain States Tumor Institute - Nampa
City
Nampa
State/Province
Idaho
ZIP/Postal Code
83686
Country
United States
Facility Name
Kootenai Cancer Center
City
Post Falls
State/Province
Idaho
ZIP/Postal Code
83854
Country
United States
Facility Name
Kootenai Cancer Clinic
City
Sandpoint
State/Province
Idaho
ZIP/Postal Code
83864
Country
United States
Facility Name
Saint Luke's Mountain States Tumor Institute-Twin Falls
City
Twin Falls
State/Province
Idaho
ZIP/Postal Code
83301
Country
United States
Facility Name
Northwestern University
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60611
Country
United States
Facility Name
Cancer Center of Kansas - Chanute
City
Chanute
State/Province
Kansas
ZIP/Postal Code
66720
Country
United States
Facility Name
Cancer Center of Kansas - Dodge City
City
Dodge City
State/Province
Kansas
ZIP/Postal Code
67801
Country
United States
Facility Name
Cancer Center of Kansas - El Dorado
City
El Dorado
State/Province
Kansas
ZIP/Postal Code
67042
Country
United States
Facility Name
Cancer Center of Kansas - Fort Scott
City
Fort Scott
State/Province
Kansas
ZIP/Postal Code
66701
Country
United States
Facility Name
Central Care Cancer Center - Garden City
City
Garden City
State/Province
Kansas
ZIP/Postal Code
67846
Country
United States
Facility Name
Central Care Cancer Center - Great Bend
City
Great Bend
State/Province
Kansas
ZIP/Postal Code
67530
Country
United States
Facility Name
Cancer Center of Kansas-Independence
City
Independence
State/Province
Kansas
ZIP/Postal Code
67301
Country
United States
Facility Name
Cancer Center of Kansas-Kingman
City
Kingman
State/Province
Kansas
ZIP/Postal Code
67068
Country
United States
Facility Name
Lawrence Memorial Hospital
City
Lawrence
State/Province
Kansas
ZIP/Postal Code
66044
Country
United States
Facility Name
Kansas Institute of Medicine Cancer and Blood Center
City
Lenexa
State/Province
Kansas
ZIP/Postal Code
66219
Country
United States
Facility Name
Minimally Invasive Surgery Hospital
City
Lenexa
State/Province
Kansas
ZIP/Postal Code
66219
Country
United States
Facility Name
Cancer Center of Kansas-Liberal
City
Liberal
State/Province
Kansas
ZIP/Postal Code
67905
Country
United States
Facility Name
Cancer Center of Kansas-Manhattan
City
Manhattan
State/Province
Kansas
ZIP/Postal Code
66502
Country
United States
Facility Name
Cancer Center of Kansas - McPherson
City
McPherson
State/Province
Kansas
ZIP/Postal Code
67460
Country
United States
Facility Name
Cancer Center of Kansas - Newton
City
Newton
State/Province
Kansas
ZIP/Postal Code
67114
Country
United States
Facility Name
Menorah Medical Center
City
Overland Park
State/Province
Kansas
ZIP/Postal Code
66209
Country
United States
Facility Name
Saint Luke's South Hospital
City
Overland Park
State/Province
Kansas
ZIP/Postal Code
66213
Country
United States
Facility Name
Cancer Center of Kansas - Parsons
City
Parsons
State/Province
Kansas
ZIP/Postal Code
67357
Country
United States
Facility Name
Cancer Center of Kansas - Pratt
City
Pratt
State/Province
Kansas
ZIP/Postal Code
67124
Country
United States
Facility Name
Cancer Center of Kansas - Salina
City
Salina
State/Province
Kansas
ZIP/Postal Code
67401
Country
United States
Facility Name
Cancer Center of Kansas - Wellington
City
Wellington
State/Province
Kansas
ZIP/Postal Code
67152
Country
United States
Facility Name
Associates In Womens Health
City
Wichita
State/Province
Kansas
ZIP/Postal Code
67208
Country
United States
Facility Name
Cancer Center of Kansas-Wichita Medical Arts Tower
City
Wichita
State/Province
Kansas
ZIP/Postal Code
67208
Country
United States
Facility Name
Cancer Center of Kansas - Wichita
City
Wichita
State/Province
Kansas
ZIP/Postal Code
67214
Country
United States
Facility Name
Via Christi Regional Medical Center
City
Wichita
State/Province
Kansas
ZIP/Postal Code
67214
Country
United States
Facility Name
Cancer Center of Kansas - Winfield
City
Winfield
State/Province
Kansas
ZIP/Postal Code
67156
Country
United States
Facility Name
Mercy Medical Center
City
Springfield
State/Province
Massachusetts
ZIP/Postal Code
01104
Country
United States
Facility Name
Saint Joseph Mercy Hospital
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48106
Country
United States
Facility Name
University of Michigan Comprehensive Cancer Center
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48109
Country
United States
Facility Name
IHA Hematology Oncology Consultants-Brighton
City
Brighton
State/Province
Michigan
ZIP/Postal Code
48114
Country
United States
Facility Name
Saint Joseph Mercy Brighton
City
Brighton
State/Province
Michigan
ZIP/Postal Code
48114
Country
United States
Facility Name
IHA Hematology Oncology Consultants-Canton
City
Canton
State/Province
Michigan
ZIP/Postal Code
48188
Country
United States
Facility Name
Saint Joseph Mercy Canton
City
Canton
State/Province
Michigan
ZIP/Postal Code
48188
Country
United States
Facility Name
Caro Cancer Center
City
Caro
State/Province
Michigan
ZIP/Postal Code
48723
Country
United States
Facility Name
IHA Hematology Oncology Consultants-Chelsea
City
Chelsea
State/Province
Michigan
ZIP/Postal Code
48118
Country
United States
Facility Name
Saint Joseph Mercy Chelsea
City
Chelsea
State/Province
Michigan
ZIP/Postal Code
48118
Country
United States
Facility Name
Hematology Oncology Consultants-Clarkston
City
Clarkston
State/Province
Michigan
ZIP/Postal Code
48346
Country
United States
Facility Name
Newland Medical Associates-Clarkston
City
Clarkston
State/Province
Michigan
ZIP/Postal Code
48346
Country
United States
Facility Name
Beaumont Hospital-Dearborn
City
Dearborn
State/Province
Michigan
ZIP/Postal Code
48124
Country
United States
Facility Name
Henry Ford Hospital
City
Detroit
State/Province
Michigan
ZIP/Postal Code
48202
Country
United States
Facility Name
Ascension Saint John Hospital
City
Detroit
State/Province
Michigan
ZIP/Postal Code
48236
Country
United States
Facility Name
Great Lakes Cancer Management Specialists-Doctors Park
City
East China Township
State/Province
Michigan
ZIP/Postal Code
48054
Country
United States
Facility Name
Genesee Cancer and Blood Disease Treatment Center
City
Flint
State/Province
Michigan
ZIP/Postal Code
48503
Country
United States
Facility Name
Genesee Hematology Oncology PC
City
Flint
State/Province
Michigan
ZIP/Postal Code
48503
Country
United States
Facility Name
Genesys Hurley Cancer Institute
City
Flint
State/Province
Michigan
ZIP/Postal Code
48503
Country
United States
Facility Name
Hurley Medical Center
City
Flint
State/Province
Michigan
ZIP/Postal Code
48503
Country
United States
Facility Name
Great Lakes Cancer Management Specialists-Van Elslander Cancer Center
City
Grosse Pointe Woods
State/Province
Michigan
ZIP/Postal Code
48236
Country
United States
Facility Name
Lymphoma Clinic of Michigan
City
Grosse Pointe Woods
State/Province
Michigan
ZIP/Postal Code
48236
Country
United States
Facility Name
Michigan Breast Specialists-Grosse Pointe Woods
City
Grosse Pointe Woods
State/Province
Michigan
ZIP/Postal Code
48236
Country
United States
Facility Name
Allegiance Health
City
Jackson
State/Province
Michigan
ZIP/Postal Code
49201
Country
United States
Facility Name
Sparrow Hospital
City
Lansing
State/Province
Michigan
ZIP/Postal Code
48912
Country
United States
Facility Name
Hope Cancer Clinic
City
Livonia
State/Province
Michigan
ZIP/Postal Code
48154
Country
United States
Facility Name
Saint Mary Mercy Hospital
City
Livonia
State/Province
Michigan
ZIP/Postal Code
48154
Country
United States
Facility Name
Great Lakes Cancer Management Specialists-Macomb Medical Campus
City
Macomb
State/Province
Michigan
ZIP/Postal Code
48044
Country
United States
Facility Name
Michigan Breast Specialists-Macomb Township
City
Macomb
State/Province
Michigan
ZIP/Postal Code
48044
Country
United States
Facility Name
Saint Mary's Oncology/Hematology Associates of Marlette
City
Marlette
State/Province
Michigan
ZIP/Postal Code
48453
Country
United States
Facility Name
21st Century Oncology-Pontiac
City
Pontiac
State/Province
Michigan
ZIP/Postal Code
48341
Country
United States
Facility Name
Hope Cancer Center
City
Pontiac
State/Province
Michigan
ZIP/Postal Code
48341
Country
United States
Facility Name
Newland Medical Associates-Pontiac
City
Pontiac
State/Province
Michigan
ZIP/Postal Code
48341
Country
United States
Facility Name
Saint Joseph Mercy Oakland
City
Pontiac
State/Province
Michigan
ZIP/Postal Code
48341
Country
United States
Facility Name
Lake Huron Medical Center
City
Port Huron
State/Province
Michigan
ZIP/Postal Code
48060
Country
United States
Facility Name
Great Lakes Cancer Management Specialists-Rochester Hills
City
Rochester Hills
State/Province
Michigan
ZIP/Postal Code
48309
Country
United States
Facility Name
Saint Mary's of Michigan
City
Saginaw
State/Province
Michigan
ZIP/Postal Code
48601
Country
United States
Facility Name
Oncology Hematology Associates of Saginaw Valley PC
City
Saginaw
State/Province
Michigan
ZIP/Postal Code
48604
Country
United States
Facility Name
Bhadresh Nayak MD PC-Sterling Heights
City
Sterling Heights
State/Province
Michigan
ZIP/Postal Code
48312
Country
United States
Facility Name
Saint Joseph Health System-Tawas City
City
Tawas City
State/Province
Michigan
ZIP/Postal Code
48764
Country
United States
Facility Name
Advanced Breast Care Center PLLC
City
Warren
State/Province
Michigan
ZIP/Postal Code
48088
Country
United States
Facility Name
Bhadresh Nayak MD PC-Warren
City
Warren
State/Province
Michigan
ZIP/Postal Code
48093
Country
United States
Facility Name
Great Lakes Cancer Management Specialists-Macomb Professional Building
City
Warren
State/Province
Michigan
ZIP/Postal Code
48093
Country
United States
Facility Name
Macomb Hematology Oncology PC
City
Warren
State/Province
Michigan
ZIP/Postal Code
48093
Country
United States
Facility Name
Michigan Breast Specialists-Warren
City
Warren
State/Province
Michigan
ZIP/Postal Code
48093
Country
United States
Facility Name
Saint John Macomb-Oakland Hospital
City
Warren
State/Province
Michigan
ZIP/Postal Code
48093
Country
United States
Facility Name
Saint Mary's Oncology/Hematology Associates of West Branch
City
West Branch
State/Province
Michigan
ZIP/Postal Code
48661
Country
United States
Facility Name
Huron Gastroenterology PC
City
Ypsilanti
State/Province
Michigan
ZIP/Postal Code
48106
Country
United States
Facility Name
IHA Hematology Oncology Consultants-Ann Arbor
City
Ypsilanti
State/Province
Michigan
ZIP/Postal Code
48197
Country
United States
Facility Name
Sanford Joe Lueken Cancer Center
City
Bemidji
State/Province
Minnesota
ZIP/Postal Code
56601
Country
United States
Facility Name
Fairview Ridges Hospital
City
Burnsville
State/Province
Minnesota
ZIP/Postal Code
55337
Country
United States
Facility Name
Mercy Hospital
City
Coon Rapids
State/Province
Minnesota
ZIP/Postal Code
55433
Country
United States
Facility Name
Fairview-Southdale Hospital
City
Edina
State/Province
Minnesota
ZIP/Postal Code
55435
Country
United States
Facility Name
Unity Hospital
City
Fridley
State/Province
Minnesota
ZIP/Postal Code
55432
Country
United States
Facility Name
Fairview Maple Grove Medical Center
City
Maple Grove
State/Province
Minnesota
ZIP/Postal Code
55369
Country
United States
Facility Name
Minnesota Oncology Hematology PA-Maplewood
City
Maplewood
State/Province
Minnesota
ZIP/Postal Code
55109
Country
United States
Facility Name
Saint John's Hospital - Healtheast
City
Maplewood
State/Province
Minnesota
ZIP/Postal Code
55109
Country
United States
Facility Name
Abbott-Northwestern Hospital
City
Minneapolis
State/Province
Minnesota
ZIP/Postal Code
55407
Country
United States
Facility Name
Hennepin County Medical Center
City
Minneapolis
State/Province
Minnesota
ZIP/Postal Code
55415
Country
United States
Facility Name
Health Partners Inc
City
Minneapolis
State/Province
Minnesota
ZIP/Postal Code
55454
Country
United States
Facility Name
New Ulm Medical Center
City
New Ulm
State/Province
Minnesota
ZIP/Postal Code
56073
Country
United States
Facility Name
North Memorial Medical Health Center
City
Robbinsdale
State/Province
Minnesota
ZIP/Postal Code
55422
Country
United States
Facility Name
Mayo Clinic
City
Rochester
State/Province
Minnesota
ZIP/Postal Code
55905
Country
United States
Facility Name
Park Nicollet Clinic - Saint Louis Park
City
Saint Louis Park
State/Province
Minnesota
ZIP/Postal Code
55416
Country
United States
Facility Name
Regions Hospital
City
Saint Paul
State/Province
Minnesota
ZIP/Postal Code
55101
Country
United States
Facility Name
United Hospital
City
Saint Paul
State/Province
Minnesota
ZIP/Postal Code
55102
Country
United States
Facility Name
Saint Francis Regional Medical Center
City
Shakopee
State/Province
Minnesota
ZIP/Postal Code
55379
Country
United States
Facility Name
Lakeview Hospital
City
Stillwater
State/Province
Minnesota
ZIP/Postal Code
55082
Country
United States
Facility Name
Ridgeview Medical Center
City
Waconia
State/Province
Minnesota
ZIP/Postal Code
55387
Country
United States
Facility Name
Rice Memorial Hospital
City
Willmar
State/Province
Minnesota
ZIP/Postal Code
56201
Country
United States
Facility Name
Minnesota Oncology Hematology PA-Woodbury
City
Woodbury
State/Province
Minnesota
ZIP/Postal Code
55125
Country
United States
Facility Name
Fairview Lakes Medical Center
City
Wyoming
State/Province
Minnesota
ZIP/Postal Code
55092
Country
United States
Facility Name
Central Care Cancer Center - Bolivar
City
Bolivar
State/Province
Missouri
ZIP/Postal Code
65613
Country
United States
Facility Name
Centerpoint Medical Center LLC
City
Independence
State/Province
Missouri
ZIP/Postal Code
64057
Country
United States
Facility Name
Freeman Health System
City
Joplin
State/Province
Missouri
ZIP/Postal Code
64804
Country
United States
Facility Name
Saint Luke's Hospital of Kansas City
City
Kansas City
State/Province
Missouri
ZIP/Postal Code
64111
Country
United States
Facility Name
Heartland Hematology and Oncology Associates Incorporated
City
Kansas City
State/Province
Missouri
ZIP/Postal Code
64118
Country
United States
Facility Name
Research Medical Center
City
Kansas City
State/Province
Missouri
ZIP/Postal Code
64132
Country
United States
Facility Name
Saint Luke's East - Lee's Summit
City
Lee's Summit
State/Province
Missouri
ZIP/Postal Code
64086
Country
United States
Facility Name
Liberty Radiation Oncology Center
City
Liberty
State/Province
Missouri
ZIP/Postal Code
64068
Country
United States
Facility Name
Delbert Day Cancer Institute at PCRMC
City
Rolla
State/Province
Missouri
ZIP/Postal Code
65401
Country
United States
Facility Name
Heartland Regional Medical Center
City
Saint Joseph
State/Province
Missouri
ZIP/Postal Code
64507
Country
United States
Facility Name
Saint Louis Cancer and Breast Institute-South City
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63109
Country
United States
Facility Name
Washington University School of Medicine
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63110
Country
United States
Facility Name
Mercy Hospital Saint Louis
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63141
Country
United States
Facility Name
Mercy Hospital Springfield
City
Springfield
State/Province
Missouri
ZIP/Postal Code
65804
Country
United States
Facility Name
CoxHealth South Hospital
City
Springfield
State/Province
Missouri
ZIP/Postal Code
65807
Country
United States
Facility Name
Community Hospital of Anaconda
City
Anaconda
State/Province
Montana
ZIP/Postal Code
59711
Country
United States
Facility Name
Billings Clinic Cancer Center
City
Billings
State/Province
Montana
ZIP/Postal Code
59101
Country
United States
Facility Name
Bozeman Deaconess Hospital
City
Bozeman
State/Province
Montana
ZIP/Postal Code
59715
Country
United States
Facility Name
Benefis Healthcare- Sletten Cancer Institute
City
Great Falls
State/Province
Montana
ZIP/Postal Code
59405
Country
United States
Facility Name
Great Falls Clinic
City
Great Falls
State/Province
Montana
ZIP/Postal Code
59405
Country
United States
Facility Name
Saint Peter's Community Hospital
City
Helena
State/Province
Montana
ZIP/Postal Code
59601
Country
United States
Facility Name
Kalispell Regional Medical Center
City
Kalispell
State/Province
Montana
ZIP/Postal Code
59901
Country
United States
Facility Name
Saint Patrick Hospital - Community Hospital
City
Missoula
State/Province
Montana
ZIP/Postal Code
59802
Country
United States
Facility Name
Community Medical Hospital
City
Missoula
State/Province
Montana
ZIP/Postal Code
59804
Country
United States
Facility Name
Sanford Bismarck Medical Center
City
Bismarck
State/Province
North Dakota
ZIP/Postal Code
58501
Country
United States
Facility Name
Roger Maris Cancer Center
City
Fargo
State/Province
North Dakota
ZIP/Postal Code
58122
Country
United States
Facility Name
Sanford Broadway Medical Center
City
Fargo
State/Province
North Dakota
ZIP/Postal Code
58122
Country
United States
Facility Name
University of Cincinnati/Barrett Cancer Center
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45219
Country
United States
Facility Name
Ohio State University Comprehensive Cancer Center
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43210
Country
United States
Facility Name
University Pointe
City
West Chester
State/Province
Ohio
ZIP/Postal Code
45069
Country
United States
Facility Name
University of Oklahoma Health Sciences Center
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73104
Country
United States
Facility Name
Oklahoma Cancer Specialists and Research Institute-Tulsa
City
Tulsa
State/Province
Oklahoma
ZIP/Postal Code
74146
Country
United States
Facility Name
Saint Alphonsus Medical Center-Baker City
City
Baker City
State/Province
Oregon
ZIP/Postal Code
97814
Country
United States
Facility Name
Saint Charles Health System
City
Bend
State/Province
Oregon
ZIP/Postal Code
97701
Country
United States
Facility Name
Clackamas Radiation Oncology Center
City
Clackamas
State/Province
Oregon
ZIP/Postal Code
97015
Country
United States
Facility Name
Providence Oncology and Hematology Care Southeast
City
Clackamas
State/Province
Oregon
ZIP/Postal Code
97015
Country
United States
Facility Name
Bay Area Hospital
City
Coos Bay
State/Province
Oregon
ZIP/Postal Code
97420
Country
United States
Facility Name
Providence Newberg Medical Center
City
Newberg
State/Province
Oregon
ZIP/Postal Code
97132
Country
United States
Facility Name
Saint Alphonsus Medical Center-Ontario
City
Ontario
State/Province
Oregon
ZIP/Postal Code
97914
Country
United States
Facility Name
Providence Willamette Falls Medical Center
City
Oregon City
State/Province
Oregon
ZIP/Postal Code
97045
Country
United States
Facility Name
Providence Portland Medical Center
City
Portland
State/Province
Oregon
ZIP/Postal Code
97213
Country
United States
Facility Name
Providence Saint Vincent Medical Center
City
Portland
State/Province
Oregon
ZIP/Postal Code
97225
Country
United States
Facility Name
Saint Charles Health System-Redmond
City
Redmond
State/Province
Oregon
ZIP/Postal Code
97756
Country
United States
Facility Name
Lehigh Valley Hospital-Cedar Crest
City
Allentown
State/Province
Pennsylvania
ZIP/Postal Code
18103
Country
United States
Facility Name
Lehigh Valley Hospital - Muhlenberg
City
Bethlehem
State/Province
Pennsylvania
ZIP/Postal Code
18017
Country
United States
Facility Name
Geisinger Medical Center
City
Danville
State/Province
Pennsylvania
ZIP/Postal Code
17822
Country
United States
Facility Name
Pocono Medical Center
City
East Stroudsburg
State/Province
Pennsylvania
ZIP/Postal Code
18301
Country
United States
Facility Name
Geisinger Medical Center-Cancer Center Hazleton
City
Hazleton
State/Province
Pennsylvania
ZIP/Postal Code
18201
Country
United States
Facility Name
Lehigh Valley Hospital-Hazleton
City
Hazleton
State/Province
Pennsylvania
ZIP/Postal Code
18201
Country
United States
Facility Name
Geisinger Medical Oncology-Lewisburg
City
Lewisburg
State/Province
Pennsylvania
ZIP/Postal Code
17837
Country
United States
Facility Name
Lewistown Hospital
City
Lewistown
State/Province
Pennsylvania
ZIP/Postal Code
17044
Country
United States
Facility Name
Geisinger Cancer Services-Pottsville
City
Pottsville
State/Province
Pennsylvania
ZIP/Postal Code
17901
Country
United States
Facility Name
Community Medical Center
City
Scranton
State/Province
Pennsylvania
ZIP/Postal Code
18510
Country
United States
Facility Name
Geisinger Medical Oncology-Selinsgrove
City
Selinsgrove
State/Province
Pennsylvania
ZIP/Postal Code
17870
Country
United States
Facility Name
Geisinger Medical Group
City
State College
State/Province
Pennsylvania
ZIP/Postal Code
16801
Country
United States
Facility Name
Geisinger Wyoming Valley/Henry Cancer Center
City
Wilkes-Barre
State/Province
Pennsylvania
ZIP/Postal Code
18711
Country
United States
Facility Name
Greenville Health System Cancer Institute-Easley
City
Easley
State/Province
South Carolina
ZIP/Postal Code
29640
Country
United States
Facility Name
Greenville Health System Cancer Institute-Andrews
City
Greenville
State/Province
South Carolina
ZIP/Postal Code
29601
Country
United States
Facility Name
Greenville Health System Cancer Institute-Butternut
City
Greenville
State/Province
South Carolina
ZIP/Postal Code
29605
Country
United States
Facility Name
Greenville Health System Cancer Institute-Faris
City
Greenville
State/Province
South Carolina
ZIP/Postal Code
29605
Country
United States
Facility Name
Greenville Memorial Hospital
City
Greenville
State/Province
South Carolina
ZIP/Postal Code
29605
Country
United States
Facility Name
Greenville Health System Cancer Institute-Eastside
City
Greenville
State/Province
South Carolina
ZIP/Postal Code
29615
Country
United States
Facility Name
Greenville Health System Cancer Institute-Greer
City
Greer
State/Province
South Carolina
ZIP/Postal Code
29650
Country
United States
Facility Name
Greenville Health System Cancer Institute-Seneca
City
Seneca
State/Province
South Carolina
ZIP/Postal Code
29672
Country
United States
Facility Name
Greenville Health System Cancer Institute-Spartanburg
City
Spartanburg
State/Province
South Carolina
ZIP/Postal Code
29307
Country
United States
Facility Name
Sanford Cancer Center Oncology Clinic
City
Sioux Falls
State/Province
South Dakota
ZIP/Postal Code
57104
Country
United States
Facility Name
Sanford USD Medical Center - Sioux Falls
City
Sioux Falls
State/Province
South Dakota
ZIP/Postal Code
57117-5134
Country
United States
Facility Name
Providence Regional Cancer System-Aberdeen
City
Aberdeen
State/Province
Washington
ZIP/Postal Code
98520
Country
United States
Facility Name
Cancer Care Center at Island Hospital
City
Anacortes
State/Province
Washington
ZIP/Postal Code
98221
Country
United States
Facility Name
Swedish Cancer Institute-Eastside Oncology Hematology
City
Bellevue
State/Province
Washington
ZIP/Postal Code
98005
Country
United States
Facility Name
PeaceHealth Saint Joseph Medical Center
City
Bellingham
State/Province
Washington
ZIP/Postal Code
98225
Country
United States
Facility Name
Harrison HealthPartners Hematology and Oncology-Bremerton
City
Bremerton
State/Province
Washington
ZIP/Postal Code
98310
Country
United States
Facility Name
Providence Regional Cancer System-Centralia
City
Centralia
State/Province
Washington
ZIP/Postal Code
98531
Country
United States
Facility Name
Swedish Medical Center-Edmonds
City
Edmonds
State/Province
Washington
ZIP/Postal Code
98026
Country
United States
Facility Name
Providence Regional Cancer Partnership
City
Everett
State/Province
Washington
ZIP/Postal Code
98201
Country
United States
Facility Name
Swedish Cancer Institute-Issaquah
City
Issaquah
State/Province
Washington
ZIP/Postal Code
98029
Country
United States
Facility Name
Kadlec Clinic Hematology and Oncology
City
Kennewick
State/Province
Washington
ZIP/Postal Code
99336
Country
United States
Facility Name
Providence Regional Cancer System-Lacey
City
Lacey
State/Province
Washington
ZIP/Postal Code
98503
Country
United States
Facility Name
PeaceHealth Saint John Medical Center
City
Longview
State/Province
Washington
ZIP/Postal Code
98632
Country
United States
Facility Name
Jefferson Healthcare
City
Port Townsend
State/Province
Washington
ZIP/Postal Code
98368
Country
United States
Facility Name
Harrison HealthPartners Hematology and Oncology-Poulsbo
City
Poulsbo
State/Province
Washington
ZIP/Postal Code
98370
Country
United States
Facility Name
Minor and James Medical PLLC
City
Seattle
State/Province
Washington
ZIP/Postal Code
98104
Country
United States
Facility Name
Pacific Gynecology Specialists
City
Seattle
State/Province
Washington
ZIP/Postal Code
98104
Country
United States
Facility Name
Swedish Medical Center-Ballard Campus
City
Seattle
State/Province
Washington
ZIP/Postal Code
98107
Country
United States
Facility Name
Kaiser Permanente Washington
City
Seattle
State/Province
Washington
ZIP/Postal Code
98112
Country
United States
Facility Name
Swedish Medical Center-First Hill
City
Seattle
State/Province
Washington
ZIP/Postal Code
98122-4307
Country
United States
Facility Name
Swedish Medical Center-Cherry Hill
City
Seattle
State/Province
Washington
ZIP/Postal Code
98122-5711
Country
United States
Facility Name
PeaceHealth United General Medical Center
City
Sedro-Woolley
State/Province
Washington
ZIP/Postal Code
98284
Country
United States
Facility Name
Providence Regional Cancer System-Shelton
City
Shelton
State/Province
Washington
ZIP/Postal Code
98584
Country
United States
Facility Name
Rockwood Clinic Cancer Treatment Center-Valley
City
Spokane Valley
State/Province
Washington
ZIP/Postal Code
99216
Country
United States
Facility Name
Rockwood Cancer Treatment Center-DHEC-Downtown
City
Spokane
State/Province
Washington
ZIP/Postal Code
99204
Country
United States
Facility Name
Evergreen Hematology and Oncology PS
City
Spokane
State/Province
Washington
ZIP/Postal Code
99218
Country
United States
Facility Name
Rockwood North Cancer Treatment Center
City
Spokane
State/Province
Washington
ZIP/Postal Code
99218
Country
United States
Facility Name
PeaceHealth Southwest Medical Center
City
Vancouver
State/Province
Washington
ZIP/Postal Code
98664
Country
United States
Facility Name
Providence Saint Mary Regional Cancer Center
City
Walla Walla
State/Province
Washington
ZIP/Postal Code
99362
Country
United States
Facility Name
North Star Lodge Cancer Center at Yakima Valley Memorial Hospital
City
Yakima
State/Province
Washington
ZIP/Postal Code
98902
Country
United States
Facility Name
Providence Regional Cancer System-Yelm
City
Yelm
State/Province
Washington
ZIP/Postal Code
98597
Country
United States
Facility Name
Froedtert and the Medical College of Wisconsin
City
Milwaukee
State/Province
Wisconsin
ZIP/Postal Code
53226
Country
United States
Facility Name
Cancer Center of Western Wisconsin
City
New Richmond
State/Province
Wisconsin
ZIP/Postal Code
54017
Country
United States
Facility Name
Billings Clinic-Cody
City
Cody
State/Province
Wyoming
ZIP/Postal Code
82414
Country
United States
Facility Name
Welch Cancer Center
City
Sheridan
State/Province
Wyoming
ZIP/Postal Code
82801
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
27240885
Citation
Cabanillas ME, McFadden DG, Durante C. Thyroid cancer. Lancet. 2016 Dec 3;388(10061):2783-2795. doi: 10.1016/S0140-6736(16)30172-6. Epub 2016 May 27.
Results Reference
derived

Learn more about this trial

Inolitazone Dihydrochloride and Paclitaxel in Treating Patients With Advanced Anaplastic Thyroid Cancer

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