bile duct cancer Cholangiocarcinoma
Conditions
Interventions
Sponsors
Quintiles
Eligibility
Age
18 Years to 64 Years
Inclusion criteria
Inclusion criteria: * Men and women, aged 18 or older.;* Histologically or cytologically confirmed cholangiocarcinoma. Subjects will be assigned to 1 of 3 cohorts:;a. Cohort A: FGFR2 translocations.;b. Cohort B: other FGF/FGFR alterations.;c. Cohort C (US only): negative for FGF/FGFR alterations.;* Radiographically measurable disease per RECIST v1.1.;* Documentation of FGF/FGFR gene alteration status.;* Documented disease progression after at least 1 line of prior systemic therapy.;* ECOG performance status of 0 to 2.;* Life expectancy * 12 weeks.
Exclusion criteria
Exclusion criteria: * Prior receipt of a selective FGFR inhibitor.;* History of and/or current evidence of ectopic mineralization/calcification, including but not limited to soft tissue, kidneys, intestine, myocardia, or lung, excepting calcified lymph nodes and asymptomatic arterial or cartilage/tendon calcifications.;* Current evidence of clinically significant corneal or retinal disorder confirmed by ophthalmologic examination.;* Use of any potent CYP3A4 inhibitors or inducers within 14 days or 5 half-lives, whichever is shorter, before the first dose of study drug.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary endpoint of this study is to determine the objective response rate (ORR) in subjects with FGFR2 translocations based on the central genomics laboratory results. Objective response rate is defined as the proportion of subjects who achieved a complete response (CR; disappearance of all target lesions) or a partial response (PR; *30% decrease in the sum of the longest diameters of target lesions) based on RECIST version 1.1. Clinical response will be determined by an independent radiological review committee. | — |
Secondary
| Measure | Time frame |
|---|---|
| * ORR in subjects with fibroblast growth factor (FGF)/FGFR alterations other than FGFR2 translocations (Cohort B). * ORR in all subjects with FGF/FGFR alterations (Cohorts A and B). * Progression-free survival (PFS = first dose to progressive disease [PD] or death; all cohorts). * Duration of response (DOR = time from the date of CR or PR until PD; all cohorts). * Disease control rate (DCR = CR + PR + stable disease; all cohorts). * Overall survival (OS = first dose to death of any cause; all cohorts). * Safety and tolerability will be assessed by evaluating the frequency, duration, and severity of adverse events; through review of findings of physical examinations, changes in vital signs, and electrocardiograms; and through clinical laboratory blood and urine sample evaluations (all cohorts). * Population pharmacokinetics (all cohorts). | — |
Countries
The Netherlands
Outcome results
None listed