Description:
The purpose of this study is evaluate the efficacy of pemigatinib in subjects with
advanced/metastatic or surgically unresectable cholangiocarcinoma with FGFR2 translocation
who have failed at least 1 previous treatment.
Title
- Brief Title: Efficacy and Safety of Pemigatinib in Subjects With Advanced/Metastatic or Surgically Unresectable Cholangiocarcinoma Who Failed Previous Therapy - (FIGHT-202)
- Official Title: A Phase 2, Open-Label, Single-Arm, Multicenter Study to Evaluate the Efficacy and Safety of Pemigatinib in Subjects With Advanced/Metastatic or Surgically Unresectable Cholangiocarcinoma Including FGFR2 Translocations Who Failed Previous Therapy - (FIGHT-202)
Clinical Trial IDs
- ORG STUDY ID:
INCB 54828-202
- NCT ID:
NCT02924376
Conditions
Interventions
Drug | Synonyms | Arms |
---|
Pemigatinib | INCB054828 | Cohort A Pemigatinib |
Purpose
The purpose of this study is evaluate the efficacy of pemigatinib in subjects with
advanced/metastatic or surgically unresectable cholangiocarcinoma with FGFR2 translocation
who have failed at least 1 previous treatment.
Trial Arms
Name | Type | Description | Interventions |
---|
Cohort A Pemigatinib | Experimental | Pemigatinib in subjects with FGFR2 translocation with a documented fusion partner in central laboratory report | |
Cohort B Pemigatinib | Experimental | Pemigatinibin subjects with other FGF/FGFR alterations | |
Cohort C Pemigatinib | Experimental | Pemigatinib in subjects negative for FGF/FGFR alteration | |
Eligibility Criteria
Inclusion Criteria:
- Histologically or cytologically confirmed cholangiocarcinoma.
- Radiographically measurable or evaluable disease per RECIST v1.1.
- Tumor assessment for FGF/FGFR gene alteration status.
- Documented disease progression after at least 1 line of prior systemic therapy.
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2.
- Life expectancy ≥ 12 weeks.
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. Topical ketoconazole will
be allowed.
Maximum Eligible Age: | N/A |
Minimum Eligible Age: | 18 Years |
Eligible Gender: | All |
Healthy Volunteers: | No |
Primary Outcome Measures
Measure: | Objective response rate (ORR) in subjects with FGFR2 translocations based on RECIST v1.1 |
Time Frame: | Every 6 weeks for the first 2 cycles and every 9 weeks thereafter through end of treatment, up to 6 months. |
Safety Issue: | |
Description: | ORR defined as the proportion of subjects who achieved a complete response (disappearance of all target lesions) or a partial response (≥ 30% decrease in the sum of the longest diameters of target lesions) based on RECIST v1.1. |
Secondary Outcome Measures
Measure: | ORR in subjects with FGF/FGFR alterations other than FGFR2 translocations, all subjects with FGF/FGFR alterations, and subjects negative for FGF/FGFR alterations, based on RECIST v1.1 |
Time Frame: | Every 6 weeks for the first 2 cycles and every 9 weeks thereafter through end of treatment, up to 6 months |
Safety Issue: | |
Description: | ORR defined as the proportion of subjects who achieved a complete response (disappearance of all target lesions) or a partial response (≥ 30% decrease in the sum of the longest diameters of target lesions) based on RECIST v1.1. |
Measure: | Progression-free survival based on RECIST v1.1 |
Time Frame: | Every 6 weeks for the first 2 cycles and every 9 weeks thereafter through end of treatment, up to 6 months. |
Safety Issue: | |
Description: | Progression-free survival defined as the time from the first day of taking study drug to death or disease progression by RECIST v1.1. |
Measure: | Safety and tolerability of pemigatinib as assessed by the frequency, duration, and severity of adverse events |
Time Frame: | From screening through 30-35 days after end of treatment, up to 6 months. |
Safety Issue: | |
Description: | |
Details
Phase: | Phase 2 |
Primary Purpose: | Interventional |
Overall Status: | Active, not recruiting |
Lead Sponsor: | Incyte Corporation |
Trial Keywords
- Cholangiocarcinoma
- fibroblast growth factor (FGF)
- fibroblast growth factor receptor (FGFR)
- FGF/FGFR alterations
Last Updated
August 27, 2021