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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02924376
Recruitment Status : Completed
First Posted : October 5, 2016
Results First Posted : February 23, 2023
Last Update Posted : February 23, 2023
Sponsor:
Information provided by (Responsible Party):
Incyte Corporation

Study Description
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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.

Condition or disease Intervention/treatment Phase
Cholangiocarcinoma Drug: Pemigatinib Phase 2

Expanded Access : An investigational treatment associated with this study is no longer available outside the clinical trial.   More info ...

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 147 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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)
Actual Study Start Date : January 16, 2017
Actual Primary Completion Date : February 1, 2022
Actual Study Completion Date : February 1, 2022

Resource links provided by the National Library of Medicine

Drug Information available for: Pemigatinib

Arms and Interventions
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Arm Intervention/treatment
Experimental: Cohort A Pemigatinib
Pemigatinib in subjects with FGFR2 translocation with a documented fusion partner in central laboratory report
 Drug: Pemigatinib
Pemigatinibonce a day by mouth for 2 consecutive weeks and 1 week off therapy
Other Name: INCB054828
Experimental: Cohort B Pemigatinib
Pemigatinibin subjects with other FGF/FGFR alterations
 Drug: Pemigatinib
Pemigatinibonce a day by mouth for 2 consecutive weeks and 1 week off therapy
Other Name: INCB054828
Experimental: Cohort C Pemigatinib
Pemigatinib in subjects negative for FGF/FGFR alteration
 Drug: Pemigatinib
Pemigatinibonce a day by mouth for 2 consecutive weeks and 1 week off therapy
Other Name: INCB054828


Outcome Measures
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Primary Outcome Measures :
  1. Objective Response Rate (ORR) in Participants With FGFR2 Rearrangements or Fusions [ Time Frame: up to 1527 days ]
    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 :
  1. ORR in Participants FGF/FGFR Alterations Other Than FGFR2 Rearrangements or Fusions [ Time Frame: up to 424 days ]
    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.

  2. ORR in All Participants With FGF/FGFR Alterations [ Time Frame: up to 1527 days ]
    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.

  3. ORR in Participants Negative for FGF/FGFR Alterations [ Time Frame: up to 143 days ]
    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.

  4. Progression-free Survival (PFS) [ Time Frame: up to 50.17 months ]
    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.

  5. Duration of Response (DOR) [ Time Frame: up to 47.11 months ]
    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.

  6. Disease Control Rate (DCR) [ Time Frame: up to 1527 days ]
    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.

  7. Overall Survival [ Time Frame: up to 51.32 months ]
    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.

  8. Number of Participants With Any Treatment-emergent Adverse Event (TEAE) [ Time Frame: up to 1584 days ]
    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.

  9. First-order Absorption Rate Constant (ka) of Pemigatinib [ Time Frame: Predose; 1-2 hours post-dose; 4-12 hours post-dose ]
    First-order absorption rate constant is defined as the rate at which a drug enters into the system.

  10. CL/F of Pemigatinib [ Time Frame: Predose; 1-2 hours post-dose; 4-12 hours post-dose ]
    CL/F is defined as apparent oral clearance.

  11. Vc/F of Pemigatinib [ Time Frame: Predose; 1-2 hours post-dose; 4-12 hours post-dose ]
    Vc/F is defined as the apparent volume of distribution for the central compartment of pemigatinib.

  12. Vp/F of Pemigatinib [ Time Frame: Predose; 1-2 hours post-dose; 4-12 hours post-dose ]
    Vp/F is defined as the apparent volume of distribution for the tissue (peripheral) compartment.


Eligibility Criteria
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Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02924376


Locations
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Sponsors and Collaborators
Incyte Corporation
Investigators
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Study Director: Luis Féliz Vinas, MD Incyte Corporation
  Study Documents (Full-Text)

Documents provided by Incyte Corporation:
Study Protocol  [PDF] April 2, 2020
Statistical Analysis Plan  [PDF] April 15, 2019

More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Incyte Corporation
ClinicalTrials.gov Identifier: NCT02924376    
Other Study ID Numbers: INCB 54828-202
First Posted: October 5, 2016    Key Record Dates
Results First Posted: February 23, 2023
Last Update Posted: February 23, 2023
Last Verified: January 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
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
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Time Frame: Data will be shared after the primary publication or 2 years after the study has ended for market authorized products and indications.
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.
URL: https://www.incyte.com/our-company/compliance-and-transparency

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Studies a U.S. FDA-regulated Drug Product: Yes
Keywords provided by Incyte Corporation:
Cholangiocarcinoma
fibroblast growth factor (FGF)
fibroblast growth factor receptor (FGFR)
FGF/FGFR alterations
Additional relevant MeSH terms:
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Cholangiocarcinoma
Adenocarcinoma
Carcinoma
 Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms