Study of Tinengotinib VS. Physician's Choice a Treatment of Subjects With FGFR-altered in Cholangiocarcinoma
Purpose
This study is a Phase III, Randomized, Controlled, Global Multicenter Study to Evaluate the Efficacy and Safety of Oral Tinengotinib versus Physician's Choice in Subjects with Fibroblast Growth Factor Receptor (FGFR)-altered, Chemotherapy- and FGFR Inhibitor-Refractory/Relapsed Cholangiocarcinoma
Condition
- Cholangiocarcinoma
Eligibility
- Eligible Ages
- Over 18 Years
- Eligible Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- ≥ 18 years of age at the time of signing the informed consent form (ICF). 2. Histologically or cytologically confirmed CCA/adenocarcinoma of biliary origin with radiological evidence of unresectable or metastatic disease. 3. Documentation of FGFR2 fusion/rearrangement gene status 4. Subjects must have received at least one line of prior chemotherapy and exactly one FDA approved FGFR inhibitor.
Exclusion Criteria
- Prior receipt of two or more FGFR inhibitors, either approved or investigational drugs. 2. Subjects with known brain or central nervous system (CNS) metastases that have radiologically or clinically progressed in the 28 days prior to initiation of therapy. Subjects with asymptomatic brain/CNS metastases or treated brain/CNS metastases that have been clinically stable for 14 days on steroids without escalation of steroids are eligible for enrollment. 3. Subjects 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, including those that have previously undergone potentially curative therapy. 4. Subjects who have received prior systemic therapy or investigational study drug ≤ 5 half-lives or 14 days, whichever is shorter, prior to starting the study drug or who have not recovered (grade ≤ 1 or at pretreatment baseline except tolerable grade 2 alopecia, fatigue/asthenia, and neuropathy due to trauma) from adverse events (AEs) of prior therapy. 5. Concurrent anticancer therapy including chemo-, immune-, or radiotherapy. Hormone therapy may be allowed with Sponsor approval. 6. Subjects who have received wide field radiotherapy ≤ 4 weeks or limited field radiation for palliation ≤ 2 weeks prior to starting the study drug or who have not recovered from AEs of prior therapy. 7. Subjects with uncontrolled hypertension (defined as blood pressure of ≥ 150 mm Hg systolic and/or ≥ 90 mm Hg diastolic despite adequate treatment with antihypertensive medications at screening)
Study Design
- Phase
- Phase 3
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel Assignment
- Primary Purpose
- Treatment
- Masking
- None (Open Label)
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
|
Experimental Tinengotinib 8 mg QD |
Tinengotinib will be administered in 28-day cycles. |
|
|
Experimental Tinengotinib 10 mg QD |
Tinengotinib will be administered in 28-day cycles. |
|
|
Active Comparator Physician's Choice |
Physician's Choice treatments include FOLFOX or FOLFIRI |
|
Recruiting Locations
UCLA Medical Center
Santa Monica, California 90401
Santa Monica, California 90401
Stanford Cancer Center
Stanford, California 94305
Stanford, California 94305
The University of Kansas Cancer Center
Westwood, Los Angeles, California 90024
Westwood, Los Angeles, California 90024
Mount Sinai Comprehensive Cancer Center
Miami Beach, Florida 33140
Miami Beach, Florida 33140
The University of Chicago Hospitals
Chicago, Illinois 60601
Chicago, Illinois 60601
Roswell Park Comprehensive Cancer Center
Buffalo, New York 14263
Buffalo, New York 14263
Messino Cancer Centers
Asheville, North Carolina 28806
Asheville, North Carolina 28806
University Hospitals Cleveland Medical Center
Cleveland, Ohio 44106
Cleveland, Ohio 44106
Tennessee Oncology- Nashville
Nashville, Tennessee 37203
Nashville, Tennessee 37203
Vanderbilt-Ingram Cancer Center
Nashville, Tennessee 37203
Nashville, Tennessee 37203
The University of Texas MD Anderson Cancer Center
Houston, Texas 77002
Houston, Texas 77002
University of Virginia Cancer Center
Charlottesville, Virginia 22908
Charlottesville, Virginia 22908
More Details
- Status
- Recruiting
- Sponsor
- TransThera Sciences (Nanjing), Inc.
Detailed Description
Approximately 200 subjects will be enrolled. Eligible subjects will be randomized in a 2:2:1 ratio to receive tinengotinib 8 mg QD, tinengotinib 10 mg QD or Physician's Choice in Part A; and eligible subjects will be randomized in a 2:1 ratio to receive the recommended Part B dose or selected dose or Physician's Choice in Part B.