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BNC105P in Combination With Everolimus/Following Everolimus For Progressive Metastatic Clear Cell Renal Cell Carcinoma

Primary Purpose

Renal Cell Carcinoma

Status
Completed
Phase
Phase 1
Locations
International
Study Type
Interventional
Intervention
Everolimus
BNC105P
Sponsored by
Hoosier Cancer Research Network
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Renal Cell Carcinoma focused on measuring Metastatic Kidney Cancer, BNC105P

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Histological or cytological proof of component (any percent) of clear cell RCC (renal cell carcinoma).
  • Metastatic or locally advanced unresectable RCC. NOTE: Prior nephrectomy is not mandatory.
  • Progressive disease after 1-2 prior VEGF-directed tyrosine kinase inhibitors (TKIs).
  • Measurable disease according to RECIST and obtained by imaging within 30 days prior to registration for protocol therapy.
  • Written informed consent and HIPAA authorization for release of personal health information.
  • Age > 18 years at the time of consent.
  • Females of childbearing potential and males must be willing to use an effective method of contraception (hormonal or barrier method of birth control; abstinence) from the time consent is signed until 4 weeks after treatment discontinuation.
  • Females of childbearing potential must have a negative pregnancy test within 7 days prior to registration for protocol therapy.

Exclusion Criteria:

  • No active brain metastases. Patients with neurological symptoms must undergo a head CT scan or brain MRI to exclude brain metastasis within 30 days prior to registration on protocol therapy. NOTE: A patient with prior brain metastasis are eligible if they have completed their radiation treatment for brain metastasis ≥30 days prior to registration for protocol therapy, are off steroids, and are asymptomatic.
  • No other currently active malignancy.
  • No treatment with any investigational agent within 14 days prior to registration for protocol therapy. NOTE: If treated with investigational agent within 14 days prior to registration, AE must be resolved back to baseline.
  • Prior cancer treatment must be completed at least 14 days prior to registration for protocol therapy and the patient must have recovered from the acute toxic effects of the regimen. With the exception of Bevacizumab treatment, which must be completed 30 days prior to registration for protocol therapy.
  • Prior radiation therapy to < 25% of the bone marrow [see bone marrow radiation chart in the study procedure manual (SPM)] allowed if completed within 30 days prior to registration for protocol therapy.
  • Corrected QT interval (QTc) ≤ 450 msec at least 7 days prior to registration for protocol therapy.
  • No clinically significant infections as judged by the treating investigator.
  • No liver disease such as cirrhosis, chronic active hepatitis or chronic persistent hepatitis.
  • No collecting duct, medullary or sarcomatoid histology.
  • No prior treatment with temsirolimus or everolimus in the phase II component of the study. NOTE: Prior treatment with these agents is permitted in the phase I component of the study.
  • No use of full dose, therapeutic anti-coagulation with warfarin or related anti-coagulants or unfractionated or low molecular weight heparins.
  • No uncontrolled hypertension (BP >150/100mmHg despite full doses of 1 anti-hypertensive medication).
  • No thrombotic event within 6 months (deep vein thrombosis, pulmonary embolism) of registration for protocol therapy.
  • No grade 2 or greater peripheral neuropathy.

Sites / Locations

  • Northwest Alabama Cancer Center
  • Genesis Cancer Center
  • Providence Health System: Roy and Patricia Disney Family Cancer Center
  • Compassionate Cancer Care Medical Group, Inc.
  • Compassionate Cancer Care Medical Group
  • City of Hope
  • Robert A. Moss, M.D., FACP, Inc.
  • California Cancer Associates for Research and Excellence
  • Marin Specialty Care
  • Good Samaritan Hospital
  • UCLA Med - Hematology & Oncology
  • Compassionate Cancer Care Medical Group
  • American Institute of Research
  • Centura Health Research Center
  • Western Oncology & Hematology
  • Cancer Care Centers of Florida: Brooksville
  • Broward Oncology Associates
  • University of Florida, Shands Cancer Center
  • Cancer Specialists of North Florida
  • Advanced Pharma CR, LLC
  • Cancer Care Centers of Florida
  • Ocala Cancer Institute
  • Cancer Care Centers of Brevard
  • Northeast Georgia Cancer Care, LLC
  • Dublin Hematology & Oncology Care
  • Kootenai Cancer Center
  • Northwestern University, Robert H. Lurie Comprehensive Cancer Center
  • Medical & Surgical Specialists, LLC
  • Edward H. Kaplan, M.D., & Associates
  • Deaconess Clinic
  • Fort Wayne Oncology & Hematology, Inc
  • IU Health Goshen
  • Indiana University Melvin and Bren Simon Cancer Center
  • IU Health Central Indiana Cancer Centers
  • Community Regional Cancer Center
  • Horizon Oncology Research
  • IU Health at Ball Memorial Hospital Cancer Center
  • Monroe Medical Associates
  • Oncology Hematology Associates of SW Indiana
  • Northern Indiana Cancer Research Consortium
  • Siouxland Hematology Oncology Associates, LLP, Nylen Cancer Center
  • Cancer Center of Kansas
  • Kentucky Cancer Clinic
  • Purchase Cancer Group
  • Medical Oncology LLC
  • Metairie Oncologists
  • Tufts Medical Center
  • St. Joseph Mercy Hospital
  • Cancer and Hematology Centers of Western Michigan
  • Metro Health Cancer Care
  • Mayo Clinic
  • Bozeman Deaconness Cancer Center
  • Sletten Cancer Specialists
  • Methodist Cancer Center
  • Dartmouth-Hitchcock Medical Center
  • Trinitas Regional Medical Center
  • Somerset Hematology Oncology Associates
  • Presbyterian Medical Group
  • University of New Mexico Cancer Center: Albuquerque
  • New York Oncology Hematology, PC
  • Roswell Park Cancer Institute
  • NYU Langone Arena Oncology
  • Tisch Cancer Institute at Mount Sinai Medical Center
  • Hematology Oncology Associates of Rockland
  • First Health of the Carolinas
  • Signal Point Clinical Research Center
  • Lawrence M. Stallings, M.D.
  • Mercy Physicians Of Oklahoma
  • Willamette Valley Cancer Institute
  • Geisinger Medical Center
  • Gettysburg Cancer Center
  • Allegheny Cancer Center
  • Mount Nittany Medical Center
  • Berks Hematology Oncology Associates
  • Hematology and Oncology Associates of Rhode Island
  • MUSC Hollings Cancer Center
  • South Carolina Cancer Specialists
  • The Jones Clinic, PC
  • Texas Oncology: Austin North
  • Texas Oncology: Bedford
  • Texas Oncology, PA
  • Texas Oncology: Fort Worth
  • Texas Oncology: Houston Memorial City
  • Methodist Hospital Research Institute
  • Houston Cancer Center
  • Joe Arrington Cancer Research and Treatment Center
  • CTRC at The UT Health Science Center at San Antonio
  • Lynchburg Hematology Oncology Clinic, Inc.
  • Harrison HealthPartners Bremerton Hematology & Oncology
  • Cascade Cancer Center
  • Group Health Medical Centers
  • University of Washington, Seattle Cancer Care Alliance
  • Rockwood Clinic
  • University of Wisconsin, Clinical Cancer Center
  • Royal Prince Alfred Hospital: Sydney Cancer Centre
  • Prince of Wales Hospital
  • Sydney Adventist Hospital Ltd.
  • Gallipoli Medical Research Foundation: Greenslopes Private Hospital
  • Royal Brisbane & Women's Hospital
  • Princess Alexandra Hospital
  • Royal Adelaide Hospital
  • Ashford Cancer Centre
  • Gallipoli Medical Research Foundation: Launceston General Hospital
  • Peninsula Oncology Centre
  • Austin Hospital
  • Alfred Hospital
  • Royal Perth Hospital
  • National Cancer Centre Singapore

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Combination Arm A: Everolimus + BNC105P

Sequential Arm B:Everolimus followed by BNC105P Monotherapy

Arm Description

Combination Arm A: Everolimus 10 mg, BNC105P MTD (from Phase 1 study) 21 day cycle

Sequential Arm B: Everolimus 10 mg, 21 day cycle Patients to receive BNC105P monotherapy at 16 mg/m2 following progression or intolerable toxicity on everolimus therapy.

Outcomes

Primary Outcome Measures

Phase I: Maximum Tolerated Dose of BNC105P in Combination With Everolimus.
Phase I
Phase I: Toxicities of BNC105P in Combination With Everolimus.
Determine the toxicities of BNC105P in combination with everolimus. Drug-related treatment emergent adverse events by CTCAE grade 2 or greater are reported
Phase II: 6-month Progression Free Survival (PFS) With the Addition of BNC105P to Everolimus.
Improvement in 6-month PFS with the addition of BNC105P to everolimus. Progression is defined using RECIST criteria as at least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions

Secondary Outcome Measures

Phase I: Response Rate of BNC105P in Combination With Everolimus.
Number of objective responses per RECIST criteria. Complete Response (CR): Disappearance of all target lesions. Partial Response (PR): At least a 30% decrease in the sum of the LD of target lesions, taking as reference the baseline sum LD. Progressive Disease (PD): At least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions. Stable Disease (SD): Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum LD since the treatment started.
Geometric Mean Half-life of BNC105 and BNC105P in Combination With Everolimus.
Determine the PK Profile for BN105P in combination with everolimus by calculating the geometric mean half-life of BNC105P
Phase II: Response Rate With Combination Therapy Compared to Everolimus Alone
Objective response is defined as a confirmed CR or PR per RECIST criteria. Complete Response (CR): Disappearance of all target lesions. Partial Response (PR): At least a 30% decrease in the sum of the LD of target lesions, taking as reference the baseline sum LD. Progressive Disease (PD): At least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions. Stable Disease (SD): Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum LD since the treatment started.
Phase II: Progression Free Survival (PFS) With BNC105P Alone in Patients After Progressing on Everolimus.
Median time to progression for arm P participants who crossed over to BNC105P monotherapy after progression. Progression is defined per RECIST criteria as at least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions
Phase II: Adverse Events of Everolimus and BNC105P When Administered as a Combination or Sequential Regimen.
Determine adverse events of everolimus and BNC105P when administered as a combination or sequential regimen. Total number of serious and non-serious adverse events for Arm A and Arm B are summarized. Complete adverse event information is supplied in the Adverse Events reporting section.
Phase II: Overall Survival
Determine overall survival probability, up to a maximum of 5 years from registration for protocol therapy.
Exploratory Objective: Correlation of PFS With Biomarkers
Exploratory analysis of serum biomarkers were undertaken to generate a potential signature for response. The correlation with 6 month progression free survival P value for four plasma biomarkers is reported.

Full Information

First Posted
December 15, 2009
Last Updated
July 7, 2022
Sponsor
Hoosier Cancer Research Network
Collaborators
Bionomics Limited
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1. Study Identification

Unique Protocol Identification Number
NCT01034631
Brief Title
BNC105P in Combination With Everolimus/Following Everolimus For Progressive Metastatic Clear Cell Renal Cell Carcinoma
Official Title
Phase I/II Study of BNC105P in Combination With Everolimus or Following Everolimus For Progressive Metastatic Clear Cell Renal Cell Carcinoma Following Prior Tyrosine Kinase Inhibitors
Study Type
Interventional

2. Study Status

Record Verification Date
April 2017
Overall Recruitment Status
Completed
Study Start Date
January 2010 (undefined)
Primary Completion Date
December 2016 (Actual)
Study Completion Date
December 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hoosier Cancer Research Network
Collaborators
Bionomics Limited

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
The purpose of this study is to determine whether BNC105P in combination with/following everolimus is effective in the treatment of progressive metastatic clear cell renal cell carcinoma following prior tyrosine kinase inhibitors.
Detailed Description
OUTLINE: This is a multi-center study. Phase I: Patients will be accrued in the classic 3 patients per dose per cohort design, 21-day cycle Dose Level 1 Everolimus 10 mg BNC105P 4.2 mg/m2 Dose Level 2 Everolimus 10 mg BNC105P 8.4 mg/m2 Dose Level 3 Everolimus 10 mg BNC105P 12.6 mg/m2 Dose Level 4 Everolimus 10 mg BNC105P 16 mg/m2 Phase II: Patients will be randomized 1:1 to Arm A or Arm B Combination Arm A: Everolimus 10 mg + BNC105P MTD (from Phase 1 study) 21 day cycle Sequential Arm B: Everolimus 10 mg 21 day cycle Patients to receive BNC105P monotherapy at 16 mg/m2 following progression or intolerable toxicity on everolimus therapy. Karnofsky Performance Score (KPS) ≥70 within 7 days prior to registration for protocol therapy. Life Expectancy: Not specified Hematopoietic: White blood cell count (WBC) > 3.5 K/mm3 Hemoglobin (Hgb) > 8.5 g/dL Platelets > 100 K/mm3 Absolute neutrophil count (ANC) > 1.5 K/mm3 Hepatic: Total Bilirubin < 1.25 x ULN Aminotransferase (AST and ALT) < 2.5 x ULN Renal: Serum Creatinine < 2.5 x ULN (upper limit normal) Cardiovascular: No significant cardiovascular events within 6 months (CVA, CAD, peripheral arterial obstruction, arrhythmias, cardiac dysfunction) of registration for protocol therapy No history of clinical CHF or LVEF <50% by Echo (or MUGA) within 30 days prior to registration for protocol therapy.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Renal Cell Carcinoma
Keywords
Metastatic Kidney Cancer, BNC105P

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
154 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Combination Arm A: Everolimus + BNC105P
Arm Type
Active Comparator
Arm Description
Combination Arm A: Everolimus 10 mg, BNC105P MTD (from Phase 1 study) 21 day cycle
Arm Title
Sequential Arm B:Everolimus followed by BNC105P Monotherapy
Arm Type
Active Comparator
Arm Description
Sequential Arm B: Everolimus 10 mg, 21 day cycle Patients to receive BNC105P monotherapy at 16 mg/m2 following progression or intolerable toxicity on everolimus therapy.
Intervention Type
Drug
Intervention Name(s)
Everolimus
Intervention Description
Everolimus 10 mg. Taken orally, every evening, 1 hr before or 2 hrs after meals
Intervention Type
Drug
Intervention Name(s)
BNC105P
Intervention Description
BNC105P, up to 16 mg/m^2
Primary Outcome Measure Information:
Title
Phase I: Maximum Tolerated Dose of BNC105P in Combination With Everolimus.
Description
Phase I
Time Frame
Until disease progression or unacceptable toxicity, up to 24 cycles or 24 months
Title
Phase I: Toxicities of BNC105P in Combination With Everolimus.
Description
Determine the toxicities of BNC105P in combination with everolimus. Drug-related treatment emergent adverse events by CTCAE grade 2 or greater are reported
Time Frame
Until disease progression or unacceptable toxicity, up to 24 cycles or 24 months
Title
Phase II: 6-month Progression Free Survival (PFS) With the Addition of BNC105P to Everolimus.
Description
Improvement in 6-month PFS with the addition of BNC105P to everolimus. Progression is defined using RECIST criteria as at least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Phase I: Response Rate of BNC105P in Combination With Everolimus.
Description
Number of objective responses per RECIST criteria. Complete Response (CR): Disappearance of all target lesions. Partial Response (PR): At least a 30% decrease in the sum of the LD of target lesions, taking as reference the baseline sum LD. Progressive Disease (PD): At least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions. Stable Disease (SD): Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum LD since the treatment started.
Time Frame
Until disease progression or unacceptable toxicity, up to 24 cycles or 24 months
Title
Geometric Mean Half-life of BNC105 and BNC105P in Combination With Everolimus.
Description
Determine the PK Profile for BN105P in combination with everolimus by calculating the geometric mean half-life of BNC105P
Time Frame
12 months
Title
Phase II: Response Rate With Combination Therapy Compared to Everolimus Alone
Description
Objective response is defined as a confirmed CR or PR per RECIST criteria. Complete Response (CR): Disappearance of all target lesions. Partial Response (PR): At least a 30% decrease in the sum of the LD of target lesions, taking as reference the baseline sum LD. Progressive Disease (PD): At least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions. Stable Disease (SD): Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum LD since the treatment started.
Time Frame
12 months
Title
Phase II: Progression Free Survival (PFS) With BNC105P Alone in Patients After Progressing on Everolimus.
Description
Median time to progression for arm P participants who crossed over to BNC105P monotherapy after progression. Progression is defined per RECIST criteria as at least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions
Time Frame
12 months
Title
Phase II: Adverse Events of Everolimus and BNC105P When Administered as a Combination or Sequential Regimen.
Description
Determine adverse events of everolimus and BNC105P when administered as a combination or sequential regimen. Total number of serious and non-serious adverse events for Arm A and Arm B are summarized. Complete adverse event information is supplied in the Adverse Events reporting section.
Time Frame
12 months
Title
Phase II: Overall Survival
Description
Determine overall survival probability, up to a maximum of 5 years from registration for protocol therapy.
Time Frame
60 months
Title
Exploratory Objective: Correlation of PFS With Biomarkers
Description
Exploratory analysis of serum biomarkers were undertaken to generate a potential signature for response. The correlation with 6 month progression free survival P value for four plasma biomarkers is reported.
Time Frame
6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Histological or cytological proof of component (any percent) of clear cell RCC (renal cell carcinoma). Metastatic or locally advanced unresectable RCC. NOTE: Prior nephrectomy is not mandatory. Progressive disease after 1-2 prior VEGF-directed tyrosine kinase inhibitors (TKIs). Measurable disease according to RECIST and obtained by imaging within 30 days prior to registration for protocol therapy. Written informed consent and HIPAA authorization for release of personal health information. Age > 18 years at the time of consent. Females of childbearing potential and males must be willing to use an effective method of contraception (hormonal or barrier method of birth control; abstinence) from the time consent is signed until 4 weeks after treatment discontinuation. Females of childbearing potential must have a negative pregnancy test within 7 days prior to registration for protocol therapy. Exclusion Criteria: No active brain metastases. Patients with neurological symptoms must undergo a head CT scan or brain MRI to exclude brain metastasis within 30 days prior to registration on protocol therapy. NOTE: A patient with prior brain metastasis are eligible if they have completed their radiation treatment for brain metastasis ≥30 days prior to registration for protocol therapy, are off steroids, and are asymptomatic. No other currently active malignancy. No treatment with any investigational agent within 14 days prior to registration for protocol therapy. NOTE: If treated with investigational agent within 14 days prior to registration, AE must be resolved back to baseline. Prior cancer treatment must be completed at least 14 days prior to registration for protocol therapy and the patient must have recovered from the acute toxic effects of the regimen. With the exception of Bevacizumab treatment, which must be completed 30 days prior to registration for protocol therapy. Prior radiation therapy to < 25% of the bone marrow [see bone marrow radiation chart in the study procedure manual (SPM)] allowed if completed within 30 days prior to registration for protocol therapy. Corrected QT interval (QTc) ≤ 450 msec at least 7 days prior to registration for protocol therapy. No clinically significant infections as judged by the treating investigator. No liver disease such as cirrhosis, chronic active hepatitis or chronic persistent hepatitis. No collecting duct, medullary or sarcomatoid histology. No prior treatment with temsirolimus or everolimus in the phase II component of the study. NOTE: Prior treatment with these agents is permitted in the phase I component of the study. No use of full dose, therapeutic anti-coagulation with warfarin or related anti-coagulants or unfractionated or low molecular weight heparins. No uncontrolled hypertension (BP >150/100mmHg despite full doses of 1 anti-hypertensive medication). No thrombotic event within 6 months (deep vein thrombosis, pulmonary embolism) of registration for protocol therapy. No grade 2 or greater peripheral neuropathy.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Thomas Hutson, D.O.
Organizational Affiliation
Hoosier Cancer Research Network
Official's Role
Study Chair
Facility Information:
Facility Name
Northwest Alabama Cancer Center
City
Muscle Shoals
State/Province
Alabama
ZIP/Postal Code
35661
Country
United States
Facility Name
Genesis Cancer Center
City
Hot Springs
State/Province
Arkansas
ZIP/Postal Code
71913
Country
United States
Facility Name
Providence Health System: Roy and Patricia Disney Family Cancer Center
City
Burbank
State/Province
California
ZIP/Postal Code
91505
Country
United States
Facility Name
Compassionate Cancer Care Medical Group, Inc.
City
Corona
State/Province
California
ZIP/Postal Code
92879
Country
United States
Facility Name
Compassionate Cancer Care Medical Group
City
Corona
State/Province
California
ZIP/Postal Code
92879
Country
United States
Facility Name
City of Hope
City
Duarte
State/Province
California
ZIP/Postal Code
91010
Country
United States
Facility Name
Robert A. Moss, M.D., FACP, Inc.
City
Fountain Valley
State/Province
California
ZIP/Postal Code
92708
Country
United States
Facility Name
California Cancer Associates for Research and Excellence
City
Fresno
State/Province
California
ZIP/Postal Code
93720
Country
United States
Facility Name
Marin Specialty Care
City
Greenbrae
State/Province
California
ZIP/Postal Code
94904
Country
United States
Facility Name
Good Samaritan Hospital
City
Los Angeles
State/Province
California
ZIP/Postal Code
90017
Country
United States
Facility Name
UCLA Med - Hematology & Oncology
City
Los Angeles
State/Province
California
ZIP/Postal Code
90095
Country
United States
Facility Name
Compassionate Cancer Care Medical Group
City
Riverside
State/Province
California
ZIP/Postal Code
92501
Country
United States
Facility Name
American Institute of Research
City
Whittier
State/Province
California
ZIP/Postal Code
90603
Country
United States
Facility Name
Centura Health Research Center
City
Denver
State/Province
Colorado
ZIP/Postal Code
80210
Country
United States
Facility Name
Western Oncology & Hematology
City
Golden
State/Province
Colorado
ZIP/Postal Code
80401
Country
United States
Facility Name
Cancer Care Centers of Florida: Brooksville
City
Brooksville
State/Province
Florida
ZIP/Postal Code
34613
Country
United States
Facility Name
Broward Oncology Associates
City
Fort Lauderdale
State/Province
Florida
ZIP/Postal Code
33308
Country
United States
Facility Name
University of Florida, Shands Cancer Center
City
Gainesville
State/Province
Florida
ZIP/Postal Code
32610
Country
United States
Facility Name
Cancer Specialists of North Florida
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32256
Country
United States
Facility Name
Advanced Pharma CR, LLC
City
Miami
State/Province
Florida
ZIP/Postal Code
33136
Country
United States
Facility Name
Cancer Care Centers of Florida
City
New Port Richey
State/Province
Florida
ZIP/Postal Code
34652
Country
United States
Facility Name
Ocala Cancer Institute
City
Ocala
State/Province
Florida
ZIP/Postal Code
34471
Country
United States
Facility Name
Cancer Care Centers of Brevard
City
Rockledge
State/Province
Florida
ZIP/Postal Code
32955
Country
United States
Facility Name
Northeast Georgia Cancer Care, LLC
City
Athens
State/Province
Georgia
ZIP/Postal Code
30607
Country
United States
Facility Name
Dublin Hematology & Oncology Care
City
Dublin
State/Province
Georgia
ZIP/Postal Code
31021
Country
United States
Facility Name
Kootenai Cancer Center
City
Post Falls
State/Province
Idaho
ZIP/Postal Code
83854
Country
United States
Facility Name
Northwestern University, Robert H. Lurie Comprehensive Cancer Center
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60611
Country
United States
Facility Name
Medical & Surgical Specialists, LLC
City
Galesburg
State/Province
Illinois
ZIP/Postal Code
61401
Country
United States
Facility Name
Edward H. Kaplan, M.D., & Associates
City
Skokie
State/Province
Illinois
ZIP/Postal Code
60076
Country
United States
Facility Name
Deaconess Clinic
City
Evansville
State/Province
Indiana
ZIP/Postal Code
47713
Country
United States
Facility Name
Fort Wayne Oncology & Hematology, Inc
City
Fort Wayne
State/Province
Indiana
ZIP/Postal Code
46815
Country
United States
Facility Name
IU Health Goshen
City
Goshen
State/Province
Indiana
ZIP/Postal Code
46527
Country
United States
Facility Name
Indiana University Melvin and Bren Simon Cancer Center
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46202
Country
United States
Facility Name
IU Health Central Indiana Cancer Centers
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46219
Country
United States
Facility Name
Community Regional Cancer Center
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46256
Country
United States
Facility Name
Horizon Oncology Research
City
Lafayette
State/Province
Indiana
ZIP/Postal Code
47905
Country
United States
Facility Name
IU Health at Ball Memorial Hospital Cancer Center
City
Muncie
State/Province
Indiana
ZIP/Postal Code
47303
Country
United States
Facility Name
Monroe Medical Associates
City
Munster
State/Province
Indiana
ZIP/Postal Code
46321
Country
United States
Facility Name
Oncology Hematology Associates of SW Indiana
City
Newburgh
State/Province
Indiana
ZIP/Postal Code
47630
Country
United States
Facility Name
Northern Indiana Cancer Research Consortium
City
South Bend
State/Province
Indiana
ZIP/Postal Code
46601
Country
United States
Facility Name
Siouxland Hematology Oncology Associates, LLP, Nylen Cancer Center
City
Sioux City
State/Province
Iowa
ZIP/Postal Code
51101
Country
United States
Facility Name
Cancer Center of Kansas
City
Wichita
State/Province
Kansas
ZIP/Postal Code
67214
Country
United States
Facility Name
Kentucky Cancer Clinic
City
Hazard
State/Province
Kentucky
ZIP/Postal Code
41701
Country
United States
Facility Name
Purchase Cancer Group
City
Paducah
State/Province
Kentucky
ZIP/Postal Code
42001
Country
United States
Facility Name
Medical Oncology LLC
City
Baton Rouge
State/Province
Louisiana
ZIP/Postal Code
70809
Country
United States
Facility Name
Metairie Oncologists
City
Metairie
State/Province
Louisiana
ZIP/Postal Code
70006
Country
United States
Facility Name
Tufts Medical Center
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02111
Country
United States
Facility Name
St. Joseph Mercy Hospital
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48106
Country
United States
Facility Name
Cancer and Hematology Centers of Western Michigan
City
Grand Rapids
State/Province
Michigan
ZIP/Postal Code
49546
Country
United States
Facility Name
Metro Health Cancer Care
City
Wyoming
State/Province
Michigan
ZIP/Postal Code
49519
Country
United States
Facility Name
Mayo Clinic
City
Rochester
State/Province
Minnesota
ZIP/Postal Code
55905
Country
United States
Facility Name
Bozeman Deaconness Cancer Center
City
Bozeman
State/Province
Montana
ZIP/Postal Code
59715
Country
United States
Facility Name
Sletten Cancer Specialists
City
Great Falls
State/Province
Montana
ZIP/Postal Code
59405
Country
United States
Facility Name
Methodist Cancer Center
City
Omaha
State/Province
Nebraska
ZIP/Postal Code
68114
Country
United States
Facility Name
Dartmouth-Hitchcock Medical Center
City
Manchester
State/Province
New Hampshire
ZIP/Postal Code
03102
Country
United States
Facility Name
Trinitas Regional Medical Center
City
Elizabeth
State/Province
New Jersey
ZIP/Postal Code
07202
Country
United States
Facility Name
Somerset Hematology Oncology Associates
City
Somerville
State/Province
New Jersey
ZIP/Postal Code
08876
Country
United States
Facility Name
Presbyterian Medical Group
City
Albuquerque
State/Province
New Mexico
ZIP/Postal Code
87110
Country
United States
Facility Name
University of New Mexico Cancer Center: Albuquerque
City
Albuquerque
State/Province
New Mexico
ZIP/Postal Code
87131
Country
United States
Facility Name
New York Oncology Hematology, PC
City
Albany
State/Province
New York
ZIP/Postal Code
12208
Country
United States
Facility Name
Roswell Park Cancer Institute
City
Buffalo
State/Province
New York
ZIP/Postal Code
14263
Country
United States
Facility Name
NYU Langone Arena Oncology
City
Lake Success
State/Province
New York
ZIP/Postal Code
11042
Country
United States
Facility Name
Tisch Cancer Institute at Mount Sinai Medical Center
City
New York
State/Province
New York
ZIP/Postal Code
10029
Country
United States
Facility Name
Hematology Oncology Associates of Rockland
City
Nyack
State/Province
New York
ZIP/Postal Code
10960
Country
United States
Facility Name
First Health of the Carolinas
City
Pinehurst
State/Province
North Carolina
ZIP/Postal Code
28374
Country
United States
Facility Name
Signal Point Clinical Research Center
City
Middletown
State/Province
Ohio
ZIP/Postal Code
45042
Country
United States
Facility Name
Lawrence M. Stallings, M.D.
City
Wooster
State/Province
Ohio
ZIP/Postal Code
44691
Country
United States
Facility Name
Mercy Physicians Of Oklahoma
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73120
Country
United States
Facility Name
Willamette Valley Cancer Institute
City
Springfield
State/Province
Oregon
ZIP/Postal Code
97477
Country
United States
Facility Name
Geisinger Medical Center
City
Danville
State/Province
Pennsylvania
ZIP/Postal Code
17822
Country
United States
Facility Name
Gettysburg Cancer Center
City
Gettysburg
State/Province
Pennsylvania
ZIP/Postal Code
17235
Country
United States
Facility Name
Allegheny Cancer Center
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15212
Country
United States
Facility Name
Mount Nittany Medical Center
City
State College
State/Province
Pennsylvania
ZIP/Postal Code
16803
Country
United States
Facility Name
Berks Hematology Oncology Associates
City
West Reading
State/Province
Pennsylvania
ZIP/Postal Code
19611
Country
United States
Facility Name
Hematology and Oncology Associates of Rhode Island
City
Cranston
State/Province
Rhode Island
ZIP/Postal Code
02920
Country
United States
Facility Name
MUSC Hollings Cancer Center
City
Charleston
State/Province
South Carolina
ZIP/Postal Code
29425
Country
United States
Facility Name
South Carolina Cancer Specialists
City
Hilton Head Island
State/Province
South Carolina
ZIP/Postal Code
29926
Country
United States
Facility Name
The Jones Clinic, PC
City
Germantown
State/Province
Tennessee
ZIP/Postal Code
38138
Country
United States
Facility Name
Texas Oncology: Austin North
City
Austin
State/Province
Texas
ZIP/Postal Code
78758
Country
United States
Facility Name
Texas Oncology: Bedford
City
Bedford
State/Province
Texas
ZIP/Postal Code
76022
Country
United States
Facility Name
Texas Oncology, PA
City
Dallas
State/Province
Texas
ZIP/Postal Code
75246
Country
United States
Facility Name
Texas Oncology: Fort Worth
City
Fort Worth
State/Province
Texas
ZIP/Postal Code
76104
Country
United States
Facility Name
Texas Oncology: Houston Memorial City
City
Houston
State/Province
Texas
ZIP/Postal Code
77024
Country
United States
Facility Name
Methodist Hospital Research Institute
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
Houston Cancer Center
City
Houston
State/Province
Texas
ZIP/Postal Code
77055
Country
United States
Facility Name
Joe Arrington Cancer Research and Treatment Center
City
Lubbock
State/Province
Texas
ZIP/Postal Code
79410
Country
United States
Facility Name
CTRC at The UT Health Science Center at San Antonio
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78229
Country
United States
Facility Name
Lynchburg Hematology Oncology Clinic, Inc.
City
Lynchburg
State/Province
Virginia
ZIP/Postal Code
24501
Country
United States
Facility Name
Harrison HealthPartners Bremerton Hematology & Oncology
City
Bremerton
State/Province
Washington
ZIP/Postal Code
98310
Country
United States
Facility Name
Cascade Cancer Center
City
Kirkland
State/Province
Washington
ZIP/Postal Code
98034
Country
United States
Facility Name
Group Health Medical Centers
City
Seattle
State/Province
Washington
ZIP/Postal Code
98109
Country
United States
Facility Name
University of Washington, Seattle Cancer Care Alliance
City
Seattle
State/Province
Washington
ZIP/Postal Code
98109
Country
United States
Facility Name
Rockwood Clinic
City
Spokane
State/Province
Washington
ZIP/Postal Code
99204
Country
United States
Facility Name
University of Wisconsin, Clinical Cancer Center
City
Milwaukee
State/Province
Wisconsin
ZIP/Postal Code
53226
Country
United States
Facility Name
Royal Prince Alfred Hospital: Sydney Cancer Centre
City
Camperdown
State/Province
New South Wales
ZIP/Postal Code
2050
Country
Australia
Facility Name
Prince of Wales Hospital
City
Randwick
State/Province
New South Wales
ZIP/Postal Code
2031
Country
Australia
Facility Name
Sydney Adventist Hospital Ltd.
City
Wahroonga
State/Province
New South Wales
ZIP/Postal Code
2076
Country
Australia
Facility Name
Gallipoli Medical Research Foundation: Greenslopes Private Hospital
City
Greenslopes
State/Province
Queensland
ZIP/Postal Code
4120
Country
Australia
Facility Name
Royal Brisbane & Women's Hospital
City
Herston
State/Province
Queensland
ZIP/Postal Code
4029
Country
Australia
Facility Name
Princess Alexandra Hospital
City
Woolloongabba
State/Province
Queensland
ZIP/Postal Code
4201
Country
Australia
Facility Name
Royal Adelaide Hospital
City
Adelaide
State/Province
South Australia
ZIP/Postal Code
5000
Country
Australia
Facility Name
Ashford Cancer Centre
City
Kurralta Park
State/Province
South Australia
ZIP/Postal Code
5037
Country
Australia
Facility Name
Gallipoli Medical Research Foundation: Launceston General Hospital
City
Launceston
State/Province
Tasmania
ZIP/Postal Code
7250
Country
Australia
Facility Name
Peninsula Oncology Centre
City
Frankston
State/Province
Victoria
ZIP/Postal Code
3199
Country
Australia
Facility Name
Austin Hospital
City
Heidelberg
State/Province
Victoria
ZIP/Postal Code
3084
Country
Australia
Facility Name
Alfred Hospital
City
Melbourne
State/Province
Victoria
ZIP/Postal Code
3004
Country
Australia
Facility Name
Royal Perth Hospital
City
Perth
State/Province
Western Australia
ZIP/Postal Code
6000
Country
Australia
Facility Name
National Cancer Centre Singapore
City
Singapore
ZIP/Postal Code
169610
Country
Singapore

12. IPD Sharing Statement

Citations:
Citation
Thomas E. Hutson, Long H. Dang, Richard C. Lauer, Alexander Starodub, Ralph J. Hauke, Matt D. Galsky, Kathryn A. Bylow, Theodore Logan, Charles Lance Cowey, David C. Bibby, Gabriel Kremmidiotis, Elizabeth E. Doolin, Tina C. Lavranos, Guru Sonpavde, Noah M. Hahn, Christopher Sweeney, John Sarantopoulos. Phase I results of a phase I/II trial of BNC105P with everolimus in metastatic renal cell carcinoma (mRCC) patients previously treated with VEGFR tyrosine kinase inhibitors. J Clin Oncol 30, 2012 (suppl; abstr 4603) http://www.asco.org/ASCOv2/Meetings/Abstracts&vmview=abst_detail_view&confID=114&abstractID=91911
Results Reference
result
Citation
John Sarantopoulos, Long H. Dang, Richard C. Lauer, Alexander Starodub, Ralph J. Hauke, Matt D. Galsky, Kathryn A. Bylow, Charles Lance Cowey, David C. Bibby, Gabriel Kremmidiotis, Elizabeth E. Doolin, Tina C. Lavranos, Jose Luis Iglesias, Guru Sonpavde, Theodore Logan, Noah M. Hahn, Christopher Sweeney, Thomas E. Hutson. A phase I/II trial of BNC105P with everolimus in metastatic renal cell carcinoma (mRCC) patients: Updated phase I results of the Disruptor-1 trial. J Clin Oncol 31, 2013 (suppl; abstr 4563. http://abstracts2.asco.org/AbstView_132_107981.html
Results Reference
result
PubMed Identifier
25788492
Citation
Pal S, Azad A, Bhatia S, Drabkin H, Costello B, Sarantopoulos J, Kanesvaran R, Lauer R, Starodub A, Hauke R, Sweeney CJ, Hahn NM, Sonpavde G, Richey S, Breen T, Kremmidiotis G, Leske A, Doolin E, Bibby DC, Simpson J, Iglesias J, Hutson T. A Phase I/II Trial of BNC105P with Everolimus in Metastatic Renal Cell Carcinoma. Clin Cancer Res. 2015 Aug 1;21(15):3420-7. doi: 10.1158/1078-0432.CCR-14-3370. Epub 2015 Mar 18.
Results Reference
result
PubMed Identifier
34108261
Citation
Yang ES, Nassar AH, Adib E, Jegede OA, Alaiwi SA, Manna DLD, Braun DA, Zarei M, Du H, Pal SK, Naik G, Sonpavde GP. Gene Expression Signature Correlates with Outcomes in Metastatic Renal Cell Carcinoma Patients Treated with Everolimus Alone or with a Vascular Disrupting Agent. Mol Cancer Ther. 2021 Aug;20(8):1454-1461. doi: 10.1158/1535-7163.MCT-20-1091. Epub 2021 Jun 9.
Results Reference
derived
Links:
URL
http://www.hoosiercancer.org
Description
Hoosier Cancer Research Network Homepage

Learn more about this trial

BNC105P in Combination With Everolimus/Following Everolimus For Progressive Metastatic Clear Cell Renal Cell Carcinoma

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