Back to resultsEfficacy and Safety of Pemigatinib in Subjects With Advanced/Metastatic or Surgically Unresectable Cholangiocarcinoma Who Failed Previous Therapy - (FIGHT-202)
Primary Purpose
Cholangiocarcinoma
Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
Pemigatinib
Sponsored by
About this trial
This is an interventional treatment trial for Cholangiocarcinoma focused on measuring Cholangiocarcinoma, fibroblast growth factor (FGF), fibroblast growth factor receptor (FGFR), FGF/FGFR alterations
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.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
Experimental
Arm Label
Cohort A Pemigatinib
Cohort B Pemigatinib
Cohort C Pemigatinib
Arm Description
Pemigatinib in subjects with FGFR2 translocation with a documented fusion partner in central laboratory report
Pemigatinibin subjects with other FGF/FGFR alterations
Pemigatinib in subjects negative for FGF/FGFR alteration
Outcomes
Primary Outcome Measures
Objective Response Rate (ORR) in Participants With FGFR2 Rearrangements or Fusions
ORR was defined as the percentage of participants with a best overall response of complete response (CR) or partial response (PR) at any post-Baseline visit prior to first progressive disease (PD), per Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 (v1.1). CR: disappearance of all target and non-target lesions and no appearance of any new lesions. Any pathological lymph nodes (whether target or non-target) must have a reduction in the short axis to <10 millimeters (mm). PR: complete disappearance or at least a 30% decrease in the sum of the diameters of target lesions, taking as a reference the baseline sum diameters, no new lesions, and no progression of non-target lesions. ORR was based on central genomics laboratory results. Response was based on review of scans by an independent centralized radiological review committee.
Secondary Outcome Measures
ORR in Participants FGF/FGFR Alterations Other Than FGFR2 Rearrangements or Fusions
ORR was defined as the percentage of participants with a best overall response of CR or PR at any post-Baseline visit prior to first PD, per RECIST v1.1. CR: disappearance of all target and non-target lesions and no appearance of any new lesions. Any pathological lymph nodes (whether target or non-target) must have a reduction in the short axis to <10 mm. PR: complete disappearance or at least a 30% decrease in the sum of the diameters of target lesions, taking as a reference the baseline sum diameters, no new lesions, and no progression of non-target lesions. ORR was based on central genomics laboratory results. Response was based on review of scans by an independent centralized radiological review committee.
ORR in All Participants With FGF/FGFR Alterations
ORR was defined as the percentage of participants with a best overall response of CR or PR at any post-Baseline visit prior to first PD, per RECIST v1.1. CR: disappearance of all target and non-target lesions and no appearance of any new lesions. Any pathological lymph nodes (whether target or non-target) must have a reduction in the short axis to <10 mm. PR: complete disappearance or at least a 30% decrease in the sum of the diameters of target lesions, taking as a reference the baseline sum diameters, no new lesions, and no progression of non-target lesions. ORR was based on central genomics laboratory results. Response was based on review of scans by an independent centralized radiological review committee.
ORR in Participants Negative for FGF/FGFR Alterations
ORR was defined as the percentage of participants with a best overall response of CR or PR at any post-Baseline visit prior to first PD, per RECIST v1.1. CR: disappearance of all target and non-target lesions and no appearance of any new lesions. Any pathological lymph nodes (whether target or non-target) must have a reduction in the short axis to <10 mm. PR: complete disappearance or at least a 30% decrease in the sum of the diameters of target lesions, taking as a reference the baseline sum diameters, no new lesions, and no progression of non-target lesions. ORR was based on central genomics laboratory results. Response was based on review of scans by an independent centralized radiological review committee.
Progression-free Survival (PFS)
PFS was defined as the length of time from the first dose of study drug (Day 1) to the earlier of death or disease progression by RECIST v1.1, as assessed by the independent centralized radiological review committee.
Duration of Response (DOR)
DOR was defined as the time from the first overall response contributing to an objective response (CR or PR) as assessed by an independent centralized radiological review committee to the earlier of death or first overall response of PD occurring after the first overall response contributing to the objective response. CR: disappearance of all target and non-target lesions and no appearance of any new lesions. Any pathological lymph nodes (whether target or non-target) must have a reduction in the short axis to <10 millimeters (mm). PR: complete disappearance or at least a 30% decrease in the sum of the diameters of target lesions, taking as a reference the baseline sum diameters, no new lesions, and no progression of non-target lesions. PD: progression of a target or non-target lesion or presence of a new lesion.
Disease Control Rate (DCR)
DCR was defined as the proportion of participants with an overall response of CR, PR, or stable disease (SD), per RECIST v1.1. CR: disappearance of all target and non-target lesions and no appearance of any new lesions. Any pathological lymph nodes (whether target or non-target) must have a reduction in the short axis to <10 mm. PR: complete disappearance or at least a 30% decrease in the sum of the diameters of target lesions, taking as a reference the baseline sum diameters, no new lesions, and no progression of non-target lesions. PD: progression of a target or non-target lesion or presence of a new lesion. SD: no change in target lesions to qualify for CR, PR, or PD.
Overall Survival
Overall survival was defined as the length of time from the first dose of study drug (Day 1) until the date of death due to any cause.
Number of Participants With Any Treatment-emergent Adverse Event (TEAE)
An adverse event (AE) was defined as any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related, that occurred after a participant provided informed consent. Abnormal laboratory values or test results occurring after informed consent constituted AEs only if they induced clinical signs or symptoms, were considered clinically meaningful, required therapy (e.g., hematologic abnormality that required transfusion), or required changes in the study drug(s). A TEAE was defined as any adverse event either reported for the first time or the worsening of a pre-existing event after the first dose of study drug and within 30 days of the last dose of study drug.
First-order Absorption Rate Constant (ka) of Pemigatinib
First-order absorption rate constant is defined as the rate at which a drug enters into the system.
CL/F of Pemigatinib
CL/F is defined as apparent oral clearance.
Vc/F of Pemigatinib
Vc/F is defined as the apparent volume of distribution for the central compartment of pemigatinib.
Vp/F of Pemigatinib
Vp/F is defined as the apparent volume of distribution for the tissue (peripheral) compartment.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02924376
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)
Study Type
Interventional
2. Study Status
Record Verification Date
January 2023
Overall Recruitment Status
Completed
Study Start Date
January 16, 2017 (Actual)
Primary Completion Date
February 1, 2022 (Actual)
Study Completion Date
February 1, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Incyte Corporation
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cholangiocarcinoma
Keywords
Cholangiocarcinoma, fibroblast growth factor (FGF), fibroblast growth factor receptor (FGFR), FGF/FGFR alterations
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
147 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Cohort A Pemigatinib
Arm Type
Experimental
Arm Description
Pemigatinib in subjects with FGFR2 translocation with a documented fusion partner in central laboratory report
Arm Title
Cohort B Pemigatinib
Arm Type
Experimental
Arm Description
Pemigatinibin subjects with other FGF/FGFR alterations
Arm Title
Cohort C Pemigatinib
Arm Type
Experimental
Arm Description
Pemigatinib in subjects negative for FGF/FGFR alteration
Intervention Type
Drug
Intervention Name(s)
Pemigatinib
Other Intervention Name(s)
INCB054828
Intervention Description
Pemigatinibonce a day by mouth for 2 consecutive weeks and 1 week off therapy
Primary Outcome Measure Information:
Title
Objective Response Rate (ORR) in Participants With FGFR2 Rearrangements or Fusions
Description
ORR was defined as the percentage of participants with a best overall response of complete response (CR) or partial response (PR) at any post-Baseline visit prior to first progressive disease (PD), per Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 (v1.1). CR: disappearance of all target and non-target lesions and no appearance of any new lesions. Any pathological lymph nodes (whether target or non-target) must have a reduction in the short axis to <10 millimeters (mm). PR: complete disappearance or at least a 30% decrease in the sum of the diameters of target lesions, taking as a reference the baseline sum diameters, no new lesions, and no progression of non-target lesions. ORR was based on central genomics laboratory results. Response was based on review of scans by an independent centralized radiological review committee.
Time Frame
up to 1527 days
Secondary Outcome Measure Information:
Title
ORR in Participants FGF/FGFR Alterations Other Than FGFR2 Rearrangements or Fusions
Description
ORR was defined as the percentage of participants with a best overall response of CR or PR at any post-Baseline visit prior to first PD, per RECIST v1.1. CR: disappearance of all target and non-target lesions and no appearance of any new lesions. Any pathological lymph nodes (whether target or non-target) must have a reduction in the short axis to <10 mm. PR: complete disappearance or at least a 30% decrease in the sum of the diameters of target lesions, taking as a reference the baseline sum diameters, no new lesions, and no progression of non-target lesions. ORR was based on central genomics laboratory results. Response was based on review of scans by an independent centralized radiological review committee.
Time Frame
up to 424 days
Title
ORR in All Participants With FGF/FGFR Alterations
Description
ORR was defined as the percentage of participants with a best overall response of CR or PR at any post-Baseline visit prior to first PD, per RECIST v1.1. CR: disappearance of all target and non-target lesions and no appearance of any new lesions. Any pathological lymph nodes (whether target or non-target) must have a reduction in the short axis to <10 mm. PR: complete disappearance or at least a 30% decrease in the sum of the diameters of target lesions, taking as a reference the baseline sum diameters, no new lesions, and no progression of non-target lesions. ORR was based on central genomics laboratory results. Response was based on review of scans by an independent centralized radiological review committee.
Time Frame
up to 1527 days
Title
ORR in Participants Negative for FGF/FGFR Alterations
Description
ORR was defined as the percentage of participants with a best overall response of CR or PR at any post-Baseline visit prior to first PD, per RECIST v1.1. CR: disappearance of all target and non-target lesions and no appearance of any new lesions. Any pathological lymph nodes (whether target or non-target) must have a reduction in the short axis to <10 mm. PR: complete disappearance or at least a 30% decrease in the sum of the diameters of target lesions, taking as a reference the baseline sum diameters, no new lesions, and no progression of non-target lesions. ORR was based on central genomics laboratory results. Response was based on review of scans by an independent centralized radiological review committee.
Time Frame
up to 143 days
Title
Progression-free Survival (PFS)
Description
PFS was defined as the length of time from the first dose of study drug (Day 1) to the earlier of death or disease progression by RECIST v1.1, as assessed by the independent centralized radiological review committee.
Time Frame
up to 50.17 months
Title
Duration of Response (DOR)
Description
DOR was defined as the time from the first overall response contributing to an objective response (CR or PR) as assessed by an independent centralized radiological review committee to the earlier of death or first overall response of PD occurring after the first overall response contributing to the objective response. CR: disappearance of all target and non-target lesions and no appearance of any new lesions. Any pathological lymph nodes (whether target or non-target) must have a reduction in the short axis to <10 millimeters (mm). PR: complete disappearance or at least a 30% decrease in the sum of the diameters of target lesions, taking as a reference the baseline sum diameters, no new lesions, and no progression of non-target lesions. PD: progression of a target or non-target lesion or presence of a new lesion.
Time Frame
up to 47.11 months
Title
Disease Control Rate (DCR)
Description
DCR was defined as the proportion of participants with an overall response of CR, PR, or stable disease (SD), per RECIST v1.1. CR: disappearance of all target and non-target lesions and no appearance of any new lesions. Any pathological lymph nodes (whether target or non-target) must have a reduction in the short axis to <10 mm. PR: complete disappearance or at least a 30% decrease in the sum of the diameters of target lesions, taking as a reference the baseline sum diameters, no new lesions, and no progression of non-target lesions. PD: progression of a target or non-target lesion or presence of a new lesion. SD: no change in target lesions to qualify for CR, PR, or PD.
Time Frame
up to 1527 days
Title
Overall Survival
Description
Overall survival was defined as the length of time from the first dose of study drug (Day 1) until the date of death due to any cause.
Time Frame
up to 51.32 months
Title
Number of Participants With Any Treatment-emergent Adverse Event (TEAE)
Description
An adverse event (AE) was defined as any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related, that occurred after a participant provided informed consent. Abnormal laboratory values or test results occurring after informed consent constituted AEs only if they induced clinical signs or symptoms, were considered clinically meaningful, required therapy (e.g., hematologic abnormality that required transfusion), or required changes in the study drug(s). A TEAE was defined as any adverse event either reported for the first time or the worsening of a pre-existing event after the first dose of study drug and within 30 days of the last dose of study drug.
Time Frame
up to 1584 days
Title
First-order Absorption Rate Constant (ka) of Pemigatinib
Description
First-order absorption rate constant is defined as the rate at which a drug enters into the system.
Time Frame
Predose; 1-2 hours post-dose; 4-12 hours post-dose
Title
CL/F of Pemigatinib
Description
CL/F is defined as apparent oral clearance.
Time Frame
Predose; 1-2 hours post-dose; 4-12 hours post-dose
Title
Vc/F of Pemigatinib
Description
Vc/F is defined as the apparent volume of distribution for the central compartment of pemigatinib.
Time Frame
Predose; 1-2 hours post-dose; 4-12 hours post-dose
Title
Vp/F of Pemigatinib
Description
Vp/F is defined as the apparent volume of distribution for the tissue (peripheral) compartment.
Time Frame
Predose; 1-2 hours post-dose; 4-12 hours post-dose
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Luis Féliz Vinas, MD
Organizational Affiliation
Incyte Corporation
Official's Role
Study Director
Facility Information:
City
Anchorage
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Alaska
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United States
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Phoenix
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Tempe
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Tucson
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Orange
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San Francisco
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Aurora
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Denver
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Newark
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Gainesville
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Miami Beach
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Chicago
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Illinois
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Evanston
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Fort Wayne
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Indiana
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Sioux City
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Iowa
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Westwood
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Louisville
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Baltimore
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Ann Arbor
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Detroit
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Rochester
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Woodbury
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Saint Louis
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Billings
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Omaha
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Morristown
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New York
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New York
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Rochester
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Charlotte
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Goldsboro
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Cincinnati
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Ohio
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Cleveland
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Portland
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Oregon
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Philadelphia
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Pennsylvania
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Pittsburgh
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Pennsylvania
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Sioux Falls
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Arlington
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Dallas
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Grapevine
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San Antonio
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United States
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The Woodlands
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Tyler
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Waco
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Salt Lake City
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Utah
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Fairfax
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Virginia
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Seattle
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Madison
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Wisconsin
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United States
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Brussels
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Belgium
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Gent
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Belgium
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Kortrijk
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Belgium
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Leuven
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Belgium
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Montpellier
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Herault
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France
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Villejuif
State/Province
Herault
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France
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Avignon
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France
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Clichy
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France
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Paris
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France
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Toulouse
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France
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Berlin
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Germany
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Bonn
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Germany
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Dresden
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Germany
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Hannover
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Germany
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Homburg
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Germany
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Leipzig
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Germany
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Mainz
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Germany
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Tuebingen
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Germany
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Jerusalem
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Israel
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Petach Tikva
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Israel
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Ramat Gan
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Israel
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Tel Aviv
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Israel
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Bari
State/Province
Castellana Grotte
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Italy
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San Giovanni Rotondo
State/Province
Foggia
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Italy
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Bergamo
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Italy
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Bologna
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Italy
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Candiolo
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Italy
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Catania
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Italy
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Faenza
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Italy
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Lecce
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Italy
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Meldola
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Italy
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Milano
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Italy
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Napoli
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Italy
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Rimini
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Italy
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Siena
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Italy
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Verona
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Italy
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Nagoya-shi
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Aichi-Ken
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Japan
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Chiba-shi
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Chiba-Ken
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Japan
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Fukuoka-shi
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Fukuoka-Ken
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Japan
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Yokohama-shi
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Kanagawa-Ken
Country
Japan
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Kyoto-shi
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Kyoto-Fu
Country
Japan
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Osaka-shi
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Osaka-Fu
Country
Japan
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Osakasayama-shi
State/Province
Osaka-Fu
Country
Japan
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Kitaadachi
State/Province
Saitama-Ken
Country
Japan
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Sunto
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Shizuoka-Ken
Country
Japan
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Koto-ku
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Tokyo-To
Country
Japan
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Shinjuku-ku
State/Province
Tokyo-To
Country
Japan
City
Goyang-si
Country
Korea, Republic of
City
Seongnam-si
Country
Korea, Republic of
City
Seoul
Country
Korea, Republic of
City
Pamplona
State/Province
Navarra
Country
Spain
City
Barcelona
Country
Spain
City
Girona
Country
Spain
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Madrid
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Spain
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Taichung
Country
Taiwan
City
Tainan
Country
Taiwan
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Taipei
Country
Taiwan
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Chiang Mai
State/Province
Muang
Country
Thailand
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Khon Kaen
State/Province
Muang
Country
Thailand
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Udon Thani
State/Province
Muang
Country
Thailand
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Bangkok
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Patumwan
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Thailand
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Bangkoknoi
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Thailand
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Cambridge
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Cambridgeshire
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United Kingdom
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Bournemouth
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Dorset
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United Kingdom
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Aberdeen
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Grampian Region
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United Kingdom
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London
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Greater London
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United Kingdom
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Cardiff
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United Kingdom
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Glasgow
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United Kingdom
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Manchester
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United Kingdom
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Sheffield
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United Kingdom
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Wirral
Country
United Kingdom
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
Incyte shares data with qualified external researchers after a research proposal is submitted. These requests are reviewed and approved by a review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations.
The trial data availability is according to the criteria and process described on https://www.incyte.com/our-company/compliance-and-transparency
IPD Sharing Time Frame
Data will be shared after the primary publication or 2 years after the study has ended for market authorized products and indications.
IPD Sharing Access Criteria
Data from eligible studies will be shared with qualified researchers according to the criteria and process described in the Data Sharing section of the www.incyteclinicaltrials.com website. For approved requests, the researchers will be granted access to anonymized data under the terms of a data sharing agreement.
IPD Sharing URL
https://www.incyte.com/our-company/compliance-and-transparency
Citations:
PubMed Identifier
35544727
Citation
Bibeau K, Feliz L, Lihou CF, Ren H, Abou-Alfa GK. Progression-Free Survival in Patients With Cholangiocarcinoma With or Without FGF/FGFR Alterations: A FIGHT-202 Post Hoc Analysis of Prior Systemic Therapy Response. JCO Precis Oncol. 2022 Apr;6:e2100414. doi: 10.1200/PO.21.00414.
Results Reference
derived
PubMed Identifier
32203698
Citation
Abou-Alfa GK, Sahai V, Hollebecque A, Vaccaro G, Melisi D, Al-Rajabi R, Paulson AS, Borad MJ, Gallinson D, Murphy AG, Oh DY, Dotan E, Catenacci DV, Van Cutsem E, Ji T, Lihou CF, Zhen H, Feliz L, Vogel A. Pemigatinib for previously treated, locally advanced or metastatic cholangiocarcinoma: a multicentre, open-label, phase 2 study. Lancet Oncol. 2020 May;21(5):671-684. doi: 10.1016/S1470-2045(20)30109-1. Epub 2020 Mar 20.
Results Reference
derived
Learn more about this trial
Efficacy and Safety of Pemigatinib in Subjects With Advanced/Metastatic or Surgically Unresectable Cholangiocarcinoma Who Failed Previous Therapy - (FIGHT-202)
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