CholangiocarcinomaPhase 2NCT02924376
Efficacy and Safety of Pemigatinib in Subjects With Advanced/Metastatic or Surgically Unresectable Cholangiocarcinoma Who Failed Previous Therapy - (FIGHT-202)
A Phase 2 study testing Pemigatinib in people with Cholangiocarcinoma, run by Incyte Corporation at 120 sites in 12 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cholangiocarcinoma
- What is being tested?
- Pemigatinib
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 147 participants
- Where
- 120 sitesin 12 countries
- Study dates
- 16 Jan 2017to 1 Feb 2022
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
120 sites in 12 countries.
120 sites in 12 countries
United States49 sites
Study site
Anchorage, Alaska
Study site
Ann Arbor, Michigan
Study site
Arlington, Texas
Study site
Aurora, Colorado
Study site
Baltimore, Maryland
Study site
Billings, Montana
Study site
Charlotte, North Carolina
Study site
Chicago, Illinois
Study site
Cincinnati, Ohio
Study site
Cleveland, Ohio
Study site
Dallas, Texas
Study site
Denver, Colorado
Study site
Detroit, Michigan
Study site
Evanston, Illinois
Study site
Fairfax, Virginia
Study site
Fort Wayne, Indiana
Study site
Gainesville, Florida
Study site
Goldsboro, North Carolina
Study site
Grapevine, Texas
Study site
Louisville, Kentucky
Study site
Madison, Wisconsin
Study site
Miami Beach, Florida
Study site
Morristown, New Jersey
Study site
New Haven, Connecticut
Study site
New York, New York
Study site
Newark, Delaware
Study site
Omaha, Nebraska
Study site
Orange, California
Study site
Philadelphia, Pennsylvania
Study site
Phoenix, Arizona
Study site
Pittsburgh, Pennsylvania
Study site
Portland, Oregon
Study site
Rochester, Minnesota
Study site
Rochester, New York
Study site
Salt Lake City, Utah
Study site
San Antonio, Texas
Study site
San Francisco, California
Study site
Seattle, Washington
Study site
Sioux City, Iowa
Study site
Sioux Falls, South Dakota
Study site
St Louis, Missouri
Study site
Tempe, Arizona
Study site
The Woodlands, Texas
Study site
Tucson, Arizona
Study site
Tyler, Texas
Study site
Waco, Texas
Study site
Washington D.C., District of Columbia
Study site
Westwood, Kansas
Study site
Woodbury, Minnesota
Italy14 sites
Study site
Bari, Castellana Grotte
Study site
Bergamo
Study site
Bologna
Study site
Candiolo
Study site
Catania
Study site
Faenza
Study site
Lecce
Study site
Meldola
Study site
Milan
Study site
Naples
Study site
Rimini
Study site
San Giovanni Rotondo, Foggia
Study site
Siena
Study site
Verona
Japan11 sites
Study site
Chiba, Chiba
Study site
Fukuoka, Fukuoka
Study site
Kitaadachi, Saitama
Study site
Kōtoku, Tokyo-To
Study site
Kyoto, Kyoto
Study site
Nagoya, Aichi-ken
Study site
Osaka, Osaka
Study site
Osakasayama-shi, Osaka
Study site
Shinjuku-ku, Tokyo-To
Study site
Sunto, Shizuoka
Study site
Yokohama, Kanagawa
United Kingdom9 sites
Study site
Aberdeen, Grampian Region
Study site
Bournemouth, Dorset
Study site
Cambridge, Cambridgeshire
Study site
Cardiff
Study site
Glasgow
Study site
London, Greater London
Study site
Manchester
Study site
Metropolitan Borough of Wirral
Study site
Sheffield
Germany8 sites
Study site
Berlin
Study site
Bonn
Study site
Dresden
Study site
Hanover
Study site
Homburg
Study site
Leipzig
Study site
Mainz
Study site
Tübingen
France6 sites
Study site
Avignon
Study site
Clichy
Study site
Montpellier, Herault
Study site
Paris
Study site
Toulouse
Study site
Villejuif, Herault
Thailand5 sites
Study site
Bangkok, Patumwan
Study site
Bangkoknoi
Study site
Chiang Mai, Muang
Study site
Khon Kaen, Muang
Study site
Udon Thani, Muang
Belgium4 sites
Study site
Brussels
Study site
Ghent
Study site
Kortrijk
Study site
Leuven
Israel4 sites
Study site
Jerusalem
Study site
Petah Tikva
Study site
Ramat Gan
Study site
Tel Aviv
Spain4 sites
Study site
Barcelona
Study site
Girona
Study site
Madrid
Study site
Pamplona, Navarre
South Korea3 sites
Study site
Goyang-si
Study site
Seongnam-si
Study site
Seoul
About this study
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)
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.
- Conditions
- Cholangiocarcinoma
- Being tested
- Pemigatinib
- Keywords
- Cholangiocarcinoma, fibroblast growth factor (FGF), fibroblast growth factor receptor (FGFR), FGF/FGFR alterations
- Medical subject headings
- Cholangiocarcinoma, Acrocephalosyndactylia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PemigatinibDrug
Also called INCB054828
Pemigatinibonce a day by mouth for 2 consecutive weeks and 1 week off therapy
| Study group | Role | What they receive |
|---|---|---|
| Cohort A Pemigatinib | Experimental | Pemigatinib in subjects with FGFR2 translocation with a documented fusion partner in central laboratory report Receives: Drug: Pemigatinib |
| Cohort B Pemigatinib | Experimental | Pemigatinibin subjects with other FGF/FGFR alterations Receives: Drug: Pemigatinib |
| Cohort C Pemigatinib | Experimental | Pemigatinib in subjects negative for FGF/FGFR alteration Receives: Drug: Pemigatinib |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: up to 1527 days
Secondary outcomes (12)
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.
Measured: up to 424 days
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.
Measured: up to 1527 days
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.
Measured: up to 143 days
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.
Measured: up to 50.17 months
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.
Measured: up to 47.11 months
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.
Measured: up to 1527 days
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.
Measured: up to 51.32 months
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.
Measured: up to 1584 days
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.
Measured: Predose; 1-2 hours post-dose; 4-12 hours post-dose
CL/F of Pemigatinib
CL/F is defined as apparent oral clearance.
Measured: Predose; 1-2 hours post-dose; 4-12 hours post-dose
Vc/F of Pemigatinib
Vc/F is defined as the apparent volume of distribution for the central compartment of pemigatinib.
Measured: Predose; 1-2 hours post-dose; 4-12 hours post-dose
Vp/F of Pemigatinib
Vp/F is defined as the apparent volume of distribution for the tissue (peripheral) compartment.
Measured: Predose; 1-2 hours post-dose; 4-12 hours post-dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Oct 2016 (estimated)
- Study start16 Jan 2017
- Primary completion1 Feb 2022
- Study completion1 Feb 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for CholangiocarcinomaStudies of the same condition, open and under way.
- More trials run by Incyte CorporationThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 147 participants (actual)
Sponsor and investigators
- Lead sponsor
- Incyte Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Luis Féliz Vinas, MD, Study director, Incyte Corporation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02924376
- Sponsor's protocol ID
- INCB 54828-202
- Other IDs
- 2016-002422-36, 2016
- Status last verified
- Aug 2025
- First submitted
- 4 Oct 2016
- Last updated
- 14 Aug 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- Individual data sharing
- Yes: 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
- Expanded access
- Available
Publications
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.
PubMed 36206041Bibeau 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.
PubMed 35544727Abou-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.
PubMed 32203698
Study at a glance
From the registry record, last updated by the sponsor on 14 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT02924376
- Acronym / sponsor ID
- INCB 54828-202
- Conditions
- Cholangiocarcinoma
- Keywords
- Cholangiocarcinoma, fibroblast growth factor (FGF), fibroblast growth factor receptor (FGFR), FGF/FGFR alterations
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 147 participants (actual)
- Lead sponsor
- Incyte CorporationIndustry (pharma, biotech, devices)
- Study start
- 16 Jan 2017 (actual)
- Primary completion
- 1 Feb 2022 (actual)
- Study completion
- 1 Feb 2022 (actual)
- First posted
- 5 Oct 2016 (estimated)
- Results
- Posted 23 Feb 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Cohort A Pemigatinib | Experimental | Drug: PemigatinibPemigatinib in subjects with FGFR2 translocation with a documented fusion partner in central laboratory report |
| Cohort B Pemigatinib | Experimental | Drug: PemigatinibPemigatinibin subjects with other FGF/FGFR alterations |
| Cohort C Pemigatinib | Experimental | Drug: PemigatinibPemigatinib in subjects negative for FGF/FGFR alteration |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PemigatinibAlso: INCB054828Pemigatinibonce a day by mouth for 2 consecutive weeks and 1 week off therapy | Drug | Cohort A Pemigatinib, Cohort B Pemigatinib, Cohort C Pemigatinib |
Primary outcome
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.
12 secondary outcomes
ORR in Participants FGF/FGFR Alterations Other Than FGFR2 Rearrangements or Fusions
Time frame: up to 424 days
ORR in All Participants With FGF/FGFR Alterations
Time frame: up to 1527 days
ORR in Participants Negative for FGF/FGFR Alterations
Time frame: up to 143 days
Progression-free Survival (PFS)
Time frame: up to 50.17 months
Duration of Response (DOR)
Time frame: up to 47.11 months
Disease Control Rate (DCR)
Time frame: up to 1527 days
Overall Survival
Time frame: up to 51.32 months
Number of Participants With Any Treatment-emergent Adverse Event (TEAE)
Time frame: up to 1584 days
First-order Absorption Rate Constant (ka) of Pemigatinib
Time frame: Predose; 1-2 hours post-dose; 4-12 hours post-dose
CL/F of Pemigatinib
Time frame: Predose; 1-2 hours post-dose; 4-12 hours post-dose
Vc/F of Pemigatinib
Time frame: Predose; 1-2 hours post-dose; 4-12 hours post-dose
Vp/F of Pemigatinib
Time frame: Predose; 1-2 hours post-dose; 4-12 hours post-dose
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Aug 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 36206041Patel 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.
- Derived from this study: PubMed 35544727Bibeau 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.
- Derived from this study: PubMed 32203698Abou-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.
- Individual participant dataSharing planned: Yes. 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
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Luis Féliz Vinas, MD study director
Incyte Corporation
120 sites in 12 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Pemigatinib in people with Cholangiocarcinoma, run by Incyte Corporation at 120 sites in 12 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 120 sites in United States, Italy, Japan, United Kingdom, Germany and 7 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 23 Feb 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Objective Response Rate (ORR) in Participants With FGFR2 Rearrangements or Fusions (time frame: up to 1527 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02924376, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Aug 2025.