Clinical Trials /

Efficacy and Safety of Pemigatinib in Subjects With Advanced/Metastatic or Surgically Unresectable Cholangiocarcinoma Who Failed Previous Therapy - (FIGHT-202)

NCT02924376

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.

Related Conditions:
  • Cholangiocarcinoma
Recruiting Status:

Active, not recruiting

Phase:

Phase 2

Trial Eligibility

Document

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

  • Cholangiocarcinoma

Interventions

DrugSynonymsArms
PemigatinibINCB054828Cohort 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

NameTypeDescriptionInterventions
Cohort A PemigatinibExperimentalPemigatinib in subjects with FGFR2 translocation with a documented fusion partner in central laboratory report
  • Pemigatinib
Cohort B PemigatinibExperimentalPemigatinibin subjects with other FGF/FGFR alterations
  • Pemigatinib
Cohort C PemigatinibExperimentalPemigatinib in subjects negative for FGF/FGFR alteration
  • Pemigatinib

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:Recruiting
Lead Sponsor:Incyte Corporation

Trial Keywords

  • Cholangiocarcinoma
  • fibroblast growth factor (FGF)
  • fibroblast growth factor receptor (FGFR)
  • FGF/FGFR alterations

Last Updated

August 16, 2019