TriangleNCT02924376 · CITED IN SOURCE DOCUMENTS
Efficacy and Safety of Pemigatinib in Subjects With Advanced/Metastatic or Surgically Unresectable Cholangiocarcinoma Who Failed Previous Therapy - (FIGHT-202)
An NCI or FDA source cites this study. A citation does not establish that it applies to an individual diagnosis.
- Phase
- PHASE2
- Status at capture
- COMPLETED
- Registry last update
- 2025-08-14
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.
Open the original ClinicalTrials.gov record → · Download preserved record
What did the study report?
Outcomes, safety and baseline populations are separate source sections. Quality-of-life measures appear under their original outcome titles.
Participant flow
Baseline characteristics
Objective Response Rate (ORR) in Participants With FGFR2 Rearrangements or Fusions
ORR in Participants FGF/FGFR Alterations Other Than FGFR2 Rearrangements or Fusions
ORR in All Participants With FGF/FGFR Alterations
ORR in Participants Negative for FGF/FGFR Alterations
Progression-free Survival (PFS)
Duration of Response (DOR)
Disease Control Rate (DCR)
Overall Survival
Number of Participants With Any Treatment-emergent Adverse Event (TEAE)
First-order Absorption Rate Constant (ka) of Pemigatinib
CL/F of Pemigatinib
Vc/F of Pemigatinib
Vp/F of Pemigatinib
Adverse events
Limitations, agreements, and source contact
Who could take part
- 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.
- healthy Volunteers
- false
- minimum Age
- 18 Years
- sex
- ALL
- std Ages
- ADULT
- OLDER_ADULT
Treatment arms and interventions
- arm Groups
- description
- Pemigatinib in subjects with FGFR2 translocation with a documented fusion partner in central laboratory report
- intervention Names
- Drug: Pemigatinib
- label
- Cohort A Pemigatinib
- type
- EXPERIMENTAL
- description
- Pemigatinibin subjects with other FGF/FGFR alterations
- intervention Names
- Drug: Pemigatinib
- label
- Cohort B Pemigatinib
- type
- EXPERIMENTAL
- description
- Pemigatinib in subjects negative for FGF/FGFR alteration
- intervention Names
- Drug: Pemigatinib
- label
- Cohort C Pemigatinib
- type
- EXPERIMENTAL
- interventions
- arm Group Labels
- Cohort A Pemigatinib
- Cohort B Pemigatinib
- Cohort C Pemigatinib
- description
- Pemigatinibonce a day by mouth for 2 consecutive weeks and 1 week off therapy
- name
- Pemigatinib
- other Names
- INCB054828
- type
- DRUG
Study design
- allocation
- NON_RANDOMIZED
- intervention Model
- PARALLEL
- masking Info
- masking
- NONE
- primary Purpose
- TREATMENT
Enrollment
- count
- 147
- type
- ACTUAL
Registered outcome plans (not posted results)
- primary Outcomes
- 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.
- measure
- Objective Response Rate (ORR) in Participants With FGFR2 Rearrangements or Fusions
- time Frame
- up to 1527 days
- secondary Outcomes
- 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.
- measure
- ORR in Participants FGF/FGFR Alterations Other Than FGFR2 Rearrangements or Fusions
- time Frame
- up to 424 days
- 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.
- measure
- ORR in All Participants With FGF/FGFR Alterations
- time Frame
- up to 1527 days
- 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.
- measure
- ORR in Participants Negative for FGF/FGFR Alterations
- time Frame
- up to 143 days
- 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.
- measure
- Progression-free Survival (PFS)
- time Frame
- up to 50.17 months
- 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.
- measure
- Duration of Response (DOR)
- time Frame
- up to 47.11 months
- 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.
- measure
- Disease Control Rate (DCR)
- time Frame
- up to 1527 days
- 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.
- measure
- Overall Survival
- time Frame
- up to 51.32 months
- 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.
- measure
- Number of Participants With Any Treatment-emergent Adverse Event (TEAE)
- time Frame
- up to 1584 days
- description
- First-order absorption rate constant is defined as the rate at which a drug enters into the system.
- measure
- First-order Absorption Rate Constant (ka) of Pemigatinib
- time Frame
- Predose; 1-2 hours post-dose; 4-12 hours post-dose
- description
- CL/F is defined as apparent oral clearance.
- measure
- CL/F of Pemigatinib
- time Frame
- Predose; 1-2 hours post-dose; 4-12 hours post-dose
- description
- Vc/F is defined as the apparent volume of distribution for the central compartment of pemigatinib.
- measure
- Vc/F of Pemigatinib
- time Frame
- Predose; 1-2 hours post-dose; 4-12 hours post-dose
- description
- Vp/F is defined as the apparent volume of distribution for the tissue (peripheral) compartment.
- measure
- Vp/F of Pemigatinib
- time Frame
- Predose; 1-2 hours post-dose; 4-12 hours post-dose
Full 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.
Source references
- references
- citation
- 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
- 36206041
- type
- DERIVED
- 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.
- pmid
- 35544727
- type
- DERIVED
- 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.
- pmid
- 32203698
- type
- DERIVED
Source notices and limitations
Discovery and provenance
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Preserved source evidence · Not medical advice