Efficacy and Safety of Pemigatinib in Subjects With Advanced/Metastatic or Surgically Unresectable Cholangiocarcinoma Who Failed Previous Therapy - (FIGHT-202)
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)
2 other identifiers
interventional
147
12 countries
120
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Jan 2017
Longer than P75 for phase_2
120 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 4, 2016
CompletedFirst Posted
Study publicly available on registry
October 5, 2016
CompletedStudy Start
First participant enrolled
January 16, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2022
CompletedResults Posted
Study results publicly available
February 23, 2023
CompletedAugust 14, 2025
August 1, 2025
5 years
October 4, 2016
January 26, 2023
August 12, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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.
up to 1527 days
Secondary Outcomes (12)
ORR in Participants FGF/FGFR Alterations Other Than FGFR2 Rearrangements or Fusions
up to 424 days
ORR in All Participants With FGF/FGFR Alterations
up to 1527 days
ORR in Participants Negative for FGF/FGFR Alterations
up to 143 days
Progression-free Survival (PFS)
up to 50.17 months
Duration of Response (DOR)
up to 47.11 months
- +7 more secondary outcomes
Study Arms (3)
Cohort A Pemigatinib
EXPERIMENTALPemigatinib in subjects with FGFR2 translocation with a documented fusion partner in central laboratory report
Cohort B Pemigatinib
EXPERIMENTALPemigatinibin subjects with other FGF/FGFR alterations
Cohort C Pemigatinib
EXPERIMENTALPemigatinib in subjects negative for FGF/FGFR alteration
Interventions
Pemigatinibonce a day by mouth for 2 consecutive weeks and 1 week off therapy
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (120)
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Anchorage, Alaska, United States
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Phoenix, Arizona, United States
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Tempe, Arizona, United States
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Tucson, Arizona, United States
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Orange, California, United States
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San Francisco, California, United States
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Aurora, Colorado, United States
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Denver, Colorado, United States
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New Haven, Connecticut, United States
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Newark, Delaware, United States
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Washington D.C., District of Columbia, United States
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Gainesville, Florida, United States
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Miami Beach, Florida, United States
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Chicago, Illinois, United States
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Evanston, Illinois, United States
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Fort Wayne, Indiana, United States
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Sioux City, Iowa, United States
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Westwood, Kansas, United States
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Louisville, Kentucky, United States
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Baltimore, Maryland, United States
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Ann Arbor, Michigan, United States
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Detroit, Michigan, United States
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Rochester, Minnesota, United States
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Woodbury, Minnesota, United States
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St Louis, Missouri, United States
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Billings, Montana, United States
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Omaha, Nebraska, United States
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Morristown, New Jersey, United States
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New York, New York, United States
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Rochester, New York, United States
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Charlotte, North Carolina, United States
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Goldsboro, North Carolina, United States
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Cincinnati, Ohio, United States
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Cleveland, Ohio, United States
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Portland, Oregon, United States
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Philadelphia, Pennsylvania, United States
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Pittsburgh, Pennsylvania, United States
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Sioux Falls, South Dakota, United States
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Arlington, Texas, United States
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Dallas, Texas, United States
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Grapevine, Texas, United States
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San Antonio, Texas, United States
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The Woodlands, Texas, United States
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Tyler, Texas, United States
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Waco, Texas, United States
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Salt Lake City, Utah, United States
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Fairfax, Virginia, United States
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Seattle, Washington, United States
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Madison, Wisconsin, United States
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Brussels, Belgium
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Ghent, Belgium
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Kortrijk, Belgium
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Leuven, Belgium
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Montpellier, Herault, France
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Villejuif, Herault, France
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Avignon, France
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Clichy, France
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Paris, France
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Toulouse, France
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Berlin, Germany
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Bonn, Germany
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Dresden, Germany
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Hanover, Germany
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Homburg, Germany
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Leipzig, Germany
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Mainz, Germany
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Tübingen, Germany
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Jerusalem, Israel
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Petah Tikva, Israel
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Ramat Gan, Israel
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Tel Aviv, Israel
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Bari, Castellana Grotte, Italy
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San Giovanni Rotondo, Foggia, Italy
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Bergamo, Italy
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Bologna, Italy
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Candiolo, Italy
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Catania, Italy
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Faenza, Italy
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Lecce, Italy
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Meldola, Italy
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Milan, Italy
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Napoli, Italy
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Rimini, Italy
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Siena, Italy
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Verona, Italy
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Nagoya, Aichi-ken, Japan
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Chiba, Chiba, Japan
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Fukuoka, Fukuoka, Japan
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Yokohama, Kanagawa, Japan
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Kyoto, Kyoto, Japan
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Osaka, Osaka, Japan
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Osakasayama-shi, Osaka, Japan
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Kitaadachi, Saitama, Japan
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Sunto, Shizuoka, Japan
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Kōtoku, Tokyo-To, Japan
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Shinjuku-ku, Tokyo-To, Japan
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Goyang-si, South Korea
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Seongnam-si, South Korea
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Seoul, South Korea
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Pamplona, Navarre, Spain
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Barcelona, Spain
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Girona, Spain
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Madrid, Spain
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Taichung, Taiwan
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Tainan, Taiwan
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Taipei, Taiwan
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Chiang Mai, Muang, Thailand
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Khon Kaen, Muang, Thailand
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Udon Thani, Muang, Thailand
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Bangkok, Patumwan, Thailand
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Bangkoknoi, Thailand
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Cambridge, Cambridgeshire, United Kingdom
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Bournemouth, Dorset, United Kingdom
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Aberdeen, Grampian Region, United Kingdom
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London, Greater London, United Kingdom
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Cardiff, United Kingdom
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Glasgow, United Kingdom
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Manchester, United Kingdom
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Metropolitan Borough of Wirral, United Kingdom
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Sheffield, United Kingdom
Related Publications (3)
Patel TH, Marcus L, Horiba MN, Donoghue M, Chatterjee S, Mishra-Kalyani PS, Schuck RN, Li Y, Zhang X, Fourie Zirkelbach J, Charlab R, Liu J, Yang Y, Lemery SJ, Pazdur R, Theoret MR, Fashoyin-Aje LA. FDA Approval Summary: Pemigatinib for Previously Treated, Unresectable Locally Advanced or Metastatic Cholangiocarcinoma with FGFR2 Fusion or Other Rearrangement. Clin Cancer Res. 2023 Mar 1;29(5):838-842. doi: 10.1158/1078-0432.CCR-22-2036.
PMID: 36206041DERIVEDBibeau 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.
PMID: 35544727DERIVEDAbou-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.
PMID: 32203698DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Study Director
- Organization
- Incyte Corporation
Study Officials
- STUDY DIRECTOR
Luis Féliz Vinas, MD
Incyte Corporation
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
- Expanded Access
- Yes
Study Record Dates
First Submitted
October 4, 2016
First Posted
October 5, 2016
Study Start
January 16, 2017
Primary Completion
February 1, 2022
Study Completion
February 1, 2022
Last Updated
August 14, 2025
Results First Posted
February 23, 2023
Record last verified: 2025-08
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, 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.
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