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Study to Evaluate the Efficacy and Safety of TT-00420 in Cholangiocarcinoma

Primary Purpose

Cholangiocarcinoma, FGFR2 Fusion, FGFR2 Gene Mutation

Status
Recruiting
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
TT-00420
Sponsored by
TransThera Sciences (Nanjing), Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cholangiocarcinoma

Eligibility Criteria

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

Inclusion Criteria:

  1. ≥ 18 years of age, at the time of signing informed consent
  2. Histologically or cytologically documented advanced/metastatic or surgically unresectable cholangiocarcinoma who have received at least one line of prior systemic chemotherapy. Patients will be assigned to 1 of 4 cohorts:

    • Cohort A1: FGFR2 fusions who have failed at least one previous treatment with an FGFR inhibitor
    • Cohort A2: FGFR2 fusions who have previously responded on at least one previous treatment with an FGFR inhibitor
    • Cohort B: other FGFR alterations, including FGFR2 mutations and FGFR1/3 alterations, including fusions
    • Cohort C: negative for FGFR alterations (FGFR wild-type)
  3. At least one measurable lesion as defined by RECIST V1.1 criteria for solid tumors5
  4. Documentation of FGFR gene alteration status
  5. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
  6. Adequate organ function confirmed at screening and within 10 days of initiating treatment, as evidenced by:

    • Absolute neutrophil count (ANC) ≥ 1.5 x 10^9/L
    • Hemoglobin (Hgb) ≥ 8 g/dl
    • Platelets (plt) ≥ 75 x 10^9/L
    • aspartate aminotransferase/serum glutamate oxaloacetate transaminase (AST/SGOT) and alanine aminotransferase/serum glutamate pyruvate transaminase (ALT/SGPT) ≤ 2.5 x Upper Limit of Normal (ULN) or ≤ 5.0 x ULN if liver metastases are present
    • Total bilirubin ≤ 1.5 x ULN
    • Calculated creatine clearance ≥ 50 mL/min (Cockcroft Gault formula
  7. Negative pregnancy test within 72 hours before starting study treatment in all premenopausal women and women < 12 months after the onset of menopause
  8. Must agree to take sufficient contraceptive methods to avoid pregnancy (including male and female participants) during the study and until at least 6 months after ceasing study treatment
  9. Able to sign informed consent and comply with the protocol

Exclusion Criteria:

  1. Women who are pregnant or lactating
  2. Women of child-bearing potential (WOCBP) who do not use adequate birth control
  3. Patients with untreated brain or central nervous system (CNS) metastases or brain/CNS metastases that have progressed (e.g. evidence of new or enlarging brain metastasis or new neurological symptoms attributable to brain/CNS metastases) Note: Patients with treated brain metastases that are off corticosteroids and have been clinically stable for 28 days are eligible for enrollment.
  4. Patients with a known concurrent malignancy that is progressing or requires active treatment. Exceptions include basal cell carcinoma of the skin, carcinoma in situ of the cervix or other noninvasive or indolent malignancy that has previously undergone potentially curative therapy.
  5. Patients with the following mood disorders as judged by the Investigator or a psychiatrist:

    • Medically documented history of or active major depressive episode, bipolar disorder (I or II), obsessive-compulsive disorder, schizophrenia; a history of suicidal attempt or ideation, or homicidal ideation (immediate risk of doing harm to others)
    • ≥ CTCAE grade 3 anxiety
  6. Impaired cardiac function or significant diseases, including but not limited to any of the following:

    • left ventricular ejection fraction (LVEF) < 45% as determined by multigated acquisition (MUGA) scan or echocardiogram (ECHO)
    • Congenital long QT syndrome
    • QTcF ≥ 480 msec on screening ECG
    • Unstable angina pectoris ≤ 3 months prior to starting study drug
    • Acute myocardial infarction ≤ 3 months prior to starting study drug
  7. Patients with uncontrolled hypertension (defined as blood pressure of ≥ 150 mmHg systolic and/or ≥ 90 mmHg diastolic at Screening)
  8. Patients with:

    • unresolved diarrhea ≥ CTCAE grade 2, or
    • impairment of gastrointestinal (GI) function, or
    • GI disease that may significantly alter the absorption of TT-00420.
  9. Other concurrent severe and/or uncontrolled concomitant medical conditions (e.g. uncontrolled hypertriglyceridemia [triglycerides > 500 mg/dL], or active or uncontrolled infection) that could cause unacceptable safety risks or compromise compliance with the protocol
  10. Patients who have received chemotherapy, targeted therapy, or immunotherapy ≤ 5 half-lives or 3 weeks, whichever is shorter, (6 weeks for nitrosourea or mitomycin-C) prior to starting study drug
  11. Patients who have received wide field radiotherapy ≤ 4 weeks or limited field radiation for palliation ≤ 2 weeks prior to starting study drug or who have not recovered from adverse events of prior therapy
  12. Patients who have undergone major surgery ≤ 4 weeks prior to starting study drug or who have not recovered from adverse events of prior therapy
  13. Patients who are currently receiving treatment with therapeutic doses of warfarin sodium (Coumadin®) or any other coumarin-derivative anticoagulants
  14. Patients who are currently receiving treatment with strong CYP3A inhibitors or inducers, or sensitive substrates of CYP3A4 ≤ 2 weeks prior to starting study drug.
  15. Patients who are using a proton pump inhibitor within 4 days prior to the start of study therapy or a histamine-2 blocker within 2 days prior to the start of study therapy.
  16. Known diagnosis of human immunodeficiency virus (HIV) infection (HIV testing is not mandatory; patients with well controlled HIV might be enrolled per investigator's discretion and Sponsor approval)
  17. Evidence of active infection with Hepatitis B or Hepatitis C that is not adequately controlled. For patients with known prior history of Hepatitis B or Hepatitis C, enrollment may be allowed per investigator's discretion and Sponsor approval.
  18. Inability to swallow or tolerate oral medication
  19. Has a history or current evidence of any condition, therapy, or laboratory abnormality that, in the opinion of the investigator, might confound the results of the trial, interfere with the patient's safe participation and compliance in the trial.

Sites / Locations

  • Providence Cancer CenterRecruiting
  • City of HopeRecruiting
  • University of California, Los Angeles, School of MedicineRecruiting
  • USO Oncology Network- Rocky Mountain Cancer CentersRecruiting
  • Mount Sinai Medical CenterRecruiting
  • University of Chicago Medical Center - Duchossis Center for Advanced MedicineRecruiting
  • University of Michigan Comprehensive Cancer CenterRecruiting
  • Henry Ford Health CenterRecruiting
  • Mayo ClinicRecruiting
  • Comprehensive Cancer Center of NevadaRecruiting
  • Summit Medical Group - Florham Park CampusRecruiting
  • Roswell Park Comprehensive Cancer CenterRecruiting
  • Stony Brook University - Long Island Cancer CenterRecruiting
  • University of Cincinnati Cancer InstituteRecruiting
  • University Hospitals Seidman Cancer CenterRecruiting
  • USO Oncology Network-Northwest Cancer Specialists, P.C.Recruiting
  • Medical College of South CarolinaRecruiting
  • The University of Tennessee Medical CenterRecruiting
  • Sarah Cannon Research Institute at Tennessee OncologyRecruiting
  • Methodist Dallas Medical CenterRecruiting
  • Parkland Health & Hospital SystemRecruiting
  • University of Texas Southwestern Harold C. Simmons Comprehensive Cancer CenterRecruiting
  • UT MD Anderson Cancer CenterRecruiting
  • USO Oncology Network-Texas OncologyRecruiting
  • USO Oncology Network-Virginia Oncology Associates - Brock Cancer Center - NorfolkRecruiting
  • USO Oncology Network-Oncology and Hematology Associates of Southwest Virginia, Inc.Recruiting
  • University of Wisconsin School of Medicine and Public HealthRecruiting
  • Medical College of WisconsinRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Experimental

Experimental

Experimental

Arm Label

Cohort A1

Cohort A2

Cohort B

Cohort C

Arm Description

FGFR2 fusions who have failed at least one previous treatment with an FGFR inhibitor

FGFR2 fusions who have previously responded on at least one previous treatment with an FGFR inhibitor and discontinued due to disease progression

Other FGFR alterations, including FGFR2 mutations and FGFR1/3 alterations, including fusions

Negative for FGFR alterations (FGFR wild-type)

Outcomes

Primary Outcome Measures

Objective Response Rate (ORR) in patients with FGFR2 fusions who have failed at least one previous treatment with an FGFR inhibitor (Cohort A1)
The proportion of subjects who achieved a complete response (CR) or a partial response (PR) based on RECIST version 1.1.
ORR in patients with FGFR2 fusions who have responded (CR or PR) on at least one previous treatment with an FGFR inhibitor and discontinued due to progressive disease (Cohort A2)
ORR in patients with FGFR alterations other than FGFR2 fusions (Cohort B)
ORR in patients without FGFR alterations (wild-type FGFR mutation status) (Cohort C)

Secondary Outcome Measures

ORR in all patients with FGFR alterations (Cohorts A and B)
Progression Free Survival (PFS) (All Cohorts)
Disease Control Rate (DCR) (All Cohorts)
Defined as CR + PR + stable disease (SD)
Overall Survival (OS) (All Cohorts)
Number of Participants With Abnormal Laboratory Values and/or Adverse Events That Are Related to Treatment (All Cohorts)
As assessed per CTCAE version 5.0
Concentration of TT-00420 at Protocol-Specified Timepoints (All Cohorts)

Full Information

First Posted
May 27, 2021
Last Updated
September 19, 2023
Sponsor
TransThera Sciences (Nanjing), Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT04919642
Brief Title
Study to Evaluate the Efficacy and Safety of TT-00420 in Cholangiocarcinoma
Official Title
A Phase II, Open Label, Multicenter Study to Evaluate the Efficacy and Safety of TT-00420 (Tinengotinib) Tablet in Adult Patients With Advanced Cholangiocarcinoma
Study Type
Interventional

2. Study Status

Record Verification Date
April 2023
Overall Recruitment Status
Recruiting
Study Start Date
December 7, 2021 (Actual)
Primary Completion Date
September 2023 (Anticipated)
Study Completion Date
September 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
TransThera Sciences (Nanjing), Inc.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
This study is an open-label, multicenter study to evaluate the efficacy and safety of TT-00420 tablet in adult patients with advanced cholangiocarcinoma.
Detailed Description
This is a Phase II, open-label study to evaluate the efficacy and safety of TT00420 in patients with advanced/metastatic and surgically unresectable cholangiocarcinoma (CCA) with 1) FGFR 2 fusions who failed prior FGFR inhibitor treatment, 2) FGFR2 fusions who responded on prior FGFR inhibitor treatment, 3) with other FGFR alterations, or 4) whose tumors do not contain a detectable FGFR alteration.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cholangiocarcinoma, FGFR2 Fusion, FGFR2 Gene Mutation, FGFR1 Alteration, FGFR3 Alteration

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
80 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Cohort A1
Arm Type
Experimental
Arm Description
FGFR2 fusions who have failed at least one previous treatment with an FGFR inhibitor
Arm Title
Cohort A2
Arm Type
Experimental
Arm Description
FGFR2 fusions who have previously responded on at least one previous treatment with an FGFR inhibitor and discontinued due to disease progression
Arm Title
Cohort B
Arm Type
Experimental
Arm Description
Other FGFR alterations, including FGFR2 mutations and FGFR1/3 alterations, including fusions
Arm Title
Cohort C
Arm Type
Experimental
Arm Description
Negative for FGFR alterations (FGFR wild-type)
Intervention Type
Drug
Intervention Name(s)
TT-00420
Intervention Description
TT-00420 tablet, administered orally once daily
Primary Outcome Measure Information:
Title
Objective Response Rate (ORR) in patients with FGFR2 fusions who have failed at least one previous treatment with an FGFR inhibitor (Cohort A1)
Description
The proportion of subjects who achieved a complete response (CR) or a partial response (PR) based on RECIST version 1.1.
Time Frame
Through study completion, an average of 9 months.
Title
ORR in patients with FGFR2 fusions who have responded (CR or PR) on at least one previous treatment with an FGFR inhibitor and discontinued due to progressive disease (Cohort A2)
Time Frame
Through study completion, an average of 9 months.
Title
ORR in patients with FGFR alterations other than FGFR2 fusions (Cohort B)
Time Frame
Through study completion, an average of 9 months.
Title
ORR in patients without FGFR alterations (wild-type FGFR mutation status) (Cohort C)
Time Frame
Through study completion, an average of 9 months.
Secondary Outcome Measure Information:
Title
ORR in all patients with FGFR alterations (Cohorts A and B)
Time Frame
Through study completion, an average of 9 months.
Title
Progression Free Survival (PFS) (All Cohorts)
Time Frame
From first study drug administration until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 24 months
Title
Disease Control Rate (DCR) (All Cohorts)
Description
Defined as CR + PR + stable disease (SD)
Time Frame
Through study completion, an average of 9 months.
Title
Overall Survival (OS) (All Cohorts)
Time Frame
From first study drug administration until the date of death from any cause, assessed up to 24 months
Title
Number of Participants With Abnormal Laboratory Values and/or Adverse Events That Are Related to Treatment (All Cohorts)
Description
As assessed per CTCAE version 5.0
Time Frame
Up to 30 days from study discontinuation
Title
Concentration of TT-00420 at Protocol-Specified Timepoints (All Cohorts)
Time Frame
From Cycle 1 to Cycle 4, an average of 4 months (each cycle is 28 days)
Other Pre-specified Outcome Measures:
Title
Genetic Alteration Status
Description
Evaluation of biomarkers, including but not limited to, FGFR mutation status
Time Frame
Through study completion, an average of 9 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: ≥ 18 years of age, at the time of signing informed consent Histologically or cytologically documented advanced/metastatic or surgically unresectable cholangiocarcinoma who have received at least one line of prior systemic chemotherapy. Patients will be assigned to 1 of 4 cohorts: Cohort A1: FGFR2 fusions who have failed at least one previous treatment with an FGFR inhibitor Cohort A2: FGFR2 fusions who have previously responded on at least one previous treatment with an FGFR inhibitor Cohort B: other FGFR alterations, including FGFR2 mutations and FGFR1/3 alterations, including fusions Cohort C: negative for FGFR alterations (FGFR wild-type) At least one measurable lesion as defined by RECIST V1.1 criteria for solid tumors5 Documentation of FGFR gene alteration status Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 Adequate organ function confirmed at screening and within 10 days of initiating treatment, as evidenced by: Absolute neutrophil count (ANC) ≥ 1.5 x 10^9/L Hemoglobin (Hgb) ≥ 8 g/dl Platelets (plt) ≥ 75 x 10^9/L aspartate aminotransferase/serum glutamate oxaloacetate transaminase (AST/SGOT) and alanine aminotransferase/serum glutamate pyruvate transaminase (ALT/SGPT) ≤ 2.5 x Upper Limit of Normal (ULN) or ≤ 5.0 x ULN if liver metastases are present Total bilirubin ≤ 1.5 x ULN Calculated creatine clearance ≥ 50 mL/min (Cockcroft Gault formula Negative pregnancy test within 72 hours before starting study treatment in all premenopausal women and women < 12 months after the onset of menopause Must agree to take sufficient contraceptive methods to avoid pregnancy (including male and female participants) during the study and until at least 6 months after ceasing study treatment Able to sign informed consent and comply with the protocol Exclusion Criteria: Women who are pregnant or lactating Women of child-bearing potential (WOCBP) who do not use adequate birth control Patients with untreated brain or central nervous system (CNS) metastases or brain/CNS metastases that have progressed (e.g. evidence of new or enlarging brain metastasis or new neurological symptoms attributable to brain/CNS metastases) Note: Patients with treated brain metastases that are off corticosteroids and have been clinically stable for 28 days are eligible for enrollment. Patients with a known concurrent malignancy that is progressing or requires active treatment. Exceptions include basal cell carcinoma of the skin, carcinoma in situ of the cervix or other noninvasive or indolent malignancy that has previously undergone potentially curative therapy. Patients with the following mood disorders as judged by the Investigator or a psychiatrist: Medically documented history of or active major depressive episode, bipolar disorder (I or II), obsessive-compulsive disorder, schizophrenia; a history of suicidal attempt or ideation, or homicidal ideation (immediate risk of doing harm to others) ≥ CTCAE grade 3 anxiety Impaired cardiac function or significant diseases, including but not limited to any of the following: left ventricular ejection fraction (LVEF) < 45% as determined by multigated acquisition (MUGA) scan or echocardiogram (ECHO) Congenital long QT syndrome QTcF ≥ 480 msec on screening ECG Unstable angina pectoris ≤ 3 months prior to starting study drug Acute myocardial infarction ≤ 3 months prior to starting study drug Patients with uncontrolled hypertension (defined as blood pressure of ≥ 150 mmHg systolic and/or ≥ 90 mmHg diastolic at Screening) Patients with: unresolved diarrhea ≥ CTCAE grade 2, or impairment of gastrointestinal (GI) function, or GI disease that may significantly alter the absorption of TT-00420. Other concurrent severe and/or uncontrolled concomitant medical conditions (e.g. uncontrolled hypertriglyceridemia [triglycerides > 500 mg/dL], or active or uncontrolled infection) that could cause unacceptable safety risks or compromise compliance with the protocol Patients who have received chemotherapy, targeted therapy, or immunotherapy ≤ 5 half-lives or 3 weeks, whichever is shorter, (6 weeks for nitrosourea or mitomycin-C) prior to starting study drug Patients who have received wide field radiotherapy ≤ 4 weeks or limited field radiation for palliation ≤ 2 weeks prior to starting study drug or who have not recovered from adverse events of prior therapy Patients who have undergone major surgery ≤ 4 weeks prior to starting study drug or who have not recovered from adverse events of prior therapy Patients who are currently receiving treatment with therapeutic doses of warfarin sodium (Coumadin®) or any other coumarin-derivative anticoagulants Patients who are currently receiving treatment with strong CYP3A inhibitors or inducers, or sensitive substrates of CYP3A4 ≤ 2 weeks prior to starting study drug. Patients who are using a proton pump inhibitor within 4 days prior to the start of study therapy or a histamine-2 blocker within 2 days prior to the start of study therapy. Known diagnosis of human immunodeficiency virus (HIV) infection (HIV testing is not mandatory; patients with well controlled HIV might be enrolled per investigator's discretion and Sponsor approval) Evidence of active infection with Hepatitis B or Hepatitis C that is not adequately controlled. For patients with known prior history of Hepatitis B or Hepatitis C, enrollment may be allowed per investigator's discretion and Sponsor approval. Inability to swallow or tolerate oral medication Has a history or current evidence of any condition, therapy, or laboratory abnormality that, in the opinion of the investigator, might confound the results of the trial, interfere with the patient's safe participation and compliance in the trial.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Peng Peng (Sponsor), Ph.D.
Phone
86-25-86901107
Email
peng_peng@transtherabio.com
First Name & Middle Initial & Last Name or Official Title & Degree
Hui Wang (Sponsor)
Phone
86-25-86901159
Email
wang_hui@transtherabio.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Milind Javle, MD
Organizational Affiliation
M.D. Anderson Cancer Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Providence Cancer Center
City
Anchorage
State/Province
Alaska
ZIP/Postal Code
99508
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Providence Cancer Institute
Phone
503-215-2614
Email
CanClinRsrchStudies@providence.org
Facility Name
City of Hope
City
Duarte
State/Province
California
ZIP/Postal Code
91010
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Daneng Li, MD
Phone
626-471-9200
Email
danli@coh.org
First Name & Middle Initial & Last Name & Degree
Daneng Li
Facility Name
University of California, Los Angeles, School of Medicine
City
Santa Monica
State/Province
California
ZIP/Postal Code
90404
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Barbara Kahn-Mills
Phone
310-825-2520
Email
BKahnMills@mednet.ucla.edu
Facility Name
USO Oncology Network- Rocky Mountain Cancer Centers
City
Denver
State/Province
Colorado
ZIP/Postal Code
80218-1237
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jennifer Hege
Email
jennifer.hege@usoncology.com
Facility Name
Mount Sinai Medical Center
City
Miami Beach
State/Province
Florida
ZIP/Postal Code
33140
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mayra Ortiz
Phone
305-674-2625
Email
Mayra.Ortiz@msmc.com
Facility Name
University of Chicago Medical Center - Duchossis Center for Advanced Medicine
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60637-1426
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
University of Chicago Medical Center
Phone
855-702-8222
Email
Cancerclinicaltrials@bsd.uchicago.edu
Facility Name
University of Michigan Comprehensive Cancer Center
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48109
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
University of Michigan Rogel Cancer AnswerLine
Phone
800-865-1125
Facility Name
Henry Ford Health Center
City
Detroit
State/Province
Michigan
ZIP/Postal Code
48202
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Cesar Figueras
Phone
313-556-8731
Email
cfiguer1@hfhs.org
Facility Name
Mayo Clinic
City
Rochester
State/Province
Minnesota
ZIP/Postal Code
55905
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Lionel Fonkoua
Email
Kankeufonkoua.lionel@mayo.edu
First Name & Middle Initial & Last Name & Degree
Lionel Fonkoua
Facility Name
Comprehensive Cancer Center of Nevada
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89169
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Melissa Vicuna
Phone
702-952-3400
Email
melissa.vicuna@usoncology.com
Facility Name
Summit Medical Group - Florham Park Campus
City
Florham Park
State/Province
New Jersey
ZIP/Postal Code
07932
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Michelle Mackenzie
Phone
973-436-1755
Email
mmackenzie@summithealth.com
Facility Name
Roswell Park Comprehensive Cancer Center
City
Buffalo
State/Province
New York
ZIP/Postal Code
14203
Country
United States
Individual Site Status
Recruiting
Facility Contact:
Phone
800-767-9355
First Name & Middle Initial & Last Name & Degree
Christos Fountzilas
Facility Name
Stony Brook University - Long Island Cancer Center
City
Stony Brook
State/Province
New York
ZIP/Postal Code
11794
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sumbul Yousafi
Email
Sumbul.Yousafi@stonybrookmedicine.edu
Facility Name
University of Cincinnati Cancer Institute
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45219
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
UCCC CTO
Phone
513-584-7698
Email
cancer@uchealth.com
Facility Name
University Hospitals Seidman Cancer Center
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44106
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Rachel Carney
Phone
216-844-7704
Email
Rachel.Carney@UHhospitals.org
Facility Name
USO Oncology Network-Northwest Cancer Specialists, P.C.
City
Portland
State/Province
Oregon
ZIP/Postal Code
97227
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Papenfuse Susan
Email
Susan.Papenfuse@USOncology.com
First Name & Middle Initial & Last Name & Degree
Thompson Jennifer
Email
Jennifer.Thompson@USONCOLOGY.COM
Facility Name
Medical College of South Carolina
City
Charleston
State/Province
South Carolina
ZIP/Postal Code
29425
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Kim Williams
Email
Kim.Williams3@prismahealth.org
Facility Name
The University of Tennessee Medical Center
City
Knoxville
State/Province
Tennessee
ZIP/Postal Code
37920
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
James Mosley
Phone
865-305-8780
First Name & Middle Initial & Last Name & Degree
Jessica Riggs
Phone
865-305-6284
Email
JRiggs@utmck.edu
Facility Name
Sarah Cannon Research Institute at Tennessee Oncology
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37203
Country
United States
Individual Site Status
Recruiting
Facility Contact:
Email
Referrals-DDUreferrals@sarahcannon.com
Facility Name
Methodist Dallas Medical Center
City
Dallas
State/Province
Texas
ZIP/Postal Code
75203
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Colette G Ngo Ndjom
Phone
214-947-4681
Email
ColetteNgoNdjom@mhd.com
Facility Name
Parkland Health & Hospital System
City
Dallas
State/Province
Texas
ZIP/Postal Code
75235
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ellen Siglinsky
Phone
214-645-9684
Email
Ellen.Siglinsky@UTSouthwestern.edu
Facility Name
University of Texas Southwestern Harold C. Simmons Comprehensive Cancer Center
City
Dallas
State/Province
Texas
ZIP/Postal Code
75235
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ellen Siglinsky
Phone
214-645-9684
Email
Ellen.Siglinsky@UTSouthwestern.edu
Facility Name
UT MD Anderson Cancer Center
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Chimela Ohaji
Phone
832-468-1772
Email
GIClinicalTrials@mdanderson.org
First Name & Middle Initial & Last Name & Degree
Milind Javle
Facility Name
USO Oncology Network-Texas Oncology
City
Tyler
State/Province
Texas
ZIP/Postal Code
75702-8363
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Shelly Maxfield
Email
Shelly.Maxfield@USOncology.com
Facility Name
USO Oncology Network-Virginia Oncology Associates - Brock Cancer Center - Norfolk
City
Norfolk
State/Province
Virginia
ZIP/Postal Code
23502-2824
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Angel Kidd
Email
angel.kidd@usoncology.com
Facility Name
USO Oncology Network-Oncology and Hematology Associates of Southwest Virginia, Inc.
City
Roanoke
State/Province
Virginia
ZIP/Postal Code
24014
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Natasha Holt
Email
natasha.holt@usoncology.com
Facility Name
University of Wisconsin School of Medicine and Public Health
City
Madison
State/Province
Wisconsin
ZIP/Postal Code
53705
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
UW Carbone Cancer Center
Phone
800-622-8922
Email
cancerconnect@uwcarbone.wisc.edu
Facility Name
Medical College of Wisconsin
City
Milwaukee
State/Province
Wisconsin
ZIP/Postal Code
53226
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Medical College of Wisconsin Clinical Trials Office
Phone
866-680-0505
Ext
8900
Email
cccto@mcw.edu

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Study to Evaluate the Efficacy and Safety of TT-00420 in Cholangiocarcinoma

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