A Phase 2, Open-Label, Single-Arm, Multicenter Study to Evaluate the Efficacy and Safety of INCB054828 in Subjects With Advanced/Metastatic or Surgically Unresectable Cholangiocarcinoma Including FGFR2 Translocations Who Failed Previous Therapy
- Conditions
- 10017991bile duct cancerCholangiocarcinoma
- Registration Number
- NL-OMON44339
- Lead Sponsor
- Quintiles
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Withdrawn
- Sex
- Not specified
- Target Recruitment
- 4
* 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.
* 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.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>The primary endpoint of this study is to determine the objective response rate<br /><br>(ORR) in subjects with FGFR2 translocations based on the central genomics<br /><br>laboratory results. Objective response rate is defined as the proportion of<br /><br>subjects who achieved a complete response (CR; disappearance of all target<br /><br>lesions) or a partial response (PR; *30% decrease in the sum of the longest<br /><br>diameters of target lesions) based on RECIST version 1.1. Clinical response<br /><br>will be determined by an independent radiological review committee.</p><br>
- Secondary Outcome Measures
Name Time Method <p>* ORR in subjects with fibroblast growth factor (FGF)/FGFR alterations other<br /><br>than FGFR2 translocations (Cohort B).<br /><br>* ORR in all subjects with FGF/FGFR alterations (Cohorts A and B).<br /><br>* Progression-free survival (PFS = first dose to progressive disease [PD] or<br /><br>death; all cohorts).<br /><br>* Duration of response (DOR = time from the date of CR or PR until PD; all<br /><br>cohorts).<br /><br>* Disease control rate (DCR = CR + PR + stable disease; all cohorts).<br /><br>* Overall survival (OS = first dose to death of any cause; all cohorts).<br /><br>* Safety and tolerability will be assessed by evaluating the frequency,<br /><br>duration, and severity of adverse events; through review of findings of<br /><br>physical examinations, changes in vital signs, and electrocardiograms; and<br /><br>through clinical laboratory blood and urine sample evaluations (all cohorts).<br /><br>* Population pharmacokinetics (all cohorts).</p><br>