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
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
200
Subjects randomized to receive tinengotinib will receive a starting dose of either 8 mg QD., self-administered orally QD in 28-day cycles.
Subjects randomized to receive tinengotinib will receive a starting dose of either10 mg QD., self-administered orally QD in 28-day cycles.
For subjects receiving FOLFOX or FOLFIRI, the subject will receive treatment every two weeks, with two administrations per each 28-day cycle.
Part A: Incidence, duration, and severity of adverse events (AEs)
As assessed per Common Terminology Criteria for Adverse Events (CTCAE) v5.0 (or the most current version).
Time frame: Up to 30 days from study discontinuation
Part B: PFS by BICR
Progression-free survival (PFS) by BICR: PFS is defined as the time from date of randomization to the date of first documented disease progression as assessed by BICR per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1, or date of death due to any cause, whichever is earlier.
Time frame: From first study drug administration until the date of first documented progression assessed by BICR or date of death from any cause, whichever came first, assessed up to 24 months
Part A: ORR by Investigator
ORR:objective response rate (ORR), 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.
Part A: DOR by Investigator
Duration of response for CR or PR based on RECIST version 1.1.
Time frame: Through study completion, an average of 9 months.
Part B:Overall Survival (OS)
OS is defined as the time from date of randomization to date of death of any cause.
Time frame: From first study drug administration until the date of death from any cause, assessed up to 24 months.
Part B: Objective Response Rate (ORR) by BICR and by Investigator:
The proportion of subjects who achieved a complete response (CR) or a partial response (PR) based on RECIST version 1.1.
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UCLA Medical Center
Santa Monica, California, United States
RECRUITINGStanford Cancer Center
Stanford, California, United States
RECRUITINGThe University of Kansas Cancer Center
Westwood, Los Angeles, California, United States
RECRUITINGMount Sinai Comprehensive Cancer Center
Miami Beach, Florida, United States
RECRUITINGThe University of Chicago Hospitals
Chicago, Illinois, United States
RECRUITINGUMass Memorial Medical Center
Worcester, Massachusetts, United States
NOT_YET_RECRUITINGUniversity of Michigan
Ann Arbor, Michigan, United States
NOT_YET_RECRUITINGHenry Ford
Detroit, Michigan, United States
NOT_YET_RECRUITINGUniversity of Minnesota- Masonic Cancer Center, M Health Fairview
Minneapolis, Minnesota, United States
NOT_YET_RECRUITINGRoswell Park Comprehensive Cancer Center
Buffalo, New York, United States
RECRUITING...and 77 more locations
Time frame: Through study completion, an average of 9 months.
Part B: Duration of Response (DOR) by BICR and by Investigator
Duration of response for CR or PR based on RECIST version 1.1.
Time frame: Through study completion, an average of 9 months.
Part B: PFS by Investigators per RECIST v1.1.
PFS is defined as the time from date of randomization to the date of first documented disease progression as assessed by BICR per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1
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.