Efficacy and Safety of Pemigatinib in Subjects With Advanced/Metastatic or Surgically Unresectable Cholangiocarcinoma Who Failed Previous Therapy - (FIGHT-202)
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ClinicalTrials.gov Identifier: NCT02924376 |
Recruitment Status :
Completed
First Posted : October 5, 2016
Last Update Posted : April 5, 2022
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Condition or disease | Intervention/treatment | Phase |
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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 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 |

Arm | Intervention/treatment |
---|---|
Experimental: Cohort A Pemigatinib
Pemigatinib in subjects with FGFR2 translocation with a documented fusion partner in central laboratory report
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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
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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
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Drug: Pemigatinib
Pemigatinibonce a day by mouth for 2 consecutive weeks and 1 week off therapy
Other Name: INCB054828 |
- Objective response rate (ORR) in subjects with FGFR2 translocations based on RECIST v1.1 [ Time Frame: Every 6 weeks for the first 2 cycles and every 9 weeks thereafter through end of treatment, up to 6 months. ]ORR defined as the proportion of subjects who achieved a complete response (disappearance of all target lesions) or a partial response (≥ 30% decrease in the sum of the longest diameters of target lesions) based on RECIST v1.1.
- ORR in subjects with FGF/FGFR alterations other than FGFR2 translocations, all subjects with FGF/FGFR alterations, and subjects negative for FGF/FGFR alterations, based on RECIST v1.1 [ Time Frame: Every 6 weeks for the first 2 cycles and every 9 weeks thereafter through end of treatment, up to 6 months ]ORR defined as the proportion of subjects who achieved a complete response (disappearance of all target lesions) or a partial response (≥ 30% decrease in the sum of the longest diameters of target lesions) based on RECIST v1.1.
- Progression-free survival based on RECIST v1.1 [ Time Frame: Every 6 weeks for the first 2 cycles and every 9 weeks thereafter through end of treatment, up to 6 months. ]Progression-free survival defined as the time from the first day of taking study drug to death or disease progression by RECIST v1.1.
- Safety and tolerability of pemigatinib as assessed by the frequency, duration, and severity of adverse events [ Time Frame: From screening through 30-35 days after end of treatment, up to 6 months. ]

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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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.

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

Study Director: | Luis Féliz Vinas, MD | Incyte Corporation |
Responsible Party: | Incyte Corporation |
ClinicalTrials.gov Identifier: | NCT02924376 |
Other Study ID Numbers: |
INCB 54828-202 |
First Posted: | October 5, 2016 Key Record Dates |
Last Update Posted: | April 5, 2022 |
Last Verified: | April 2022 |
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 |
Cholangiocarcinoma fibroblast growth factor (FGF) fibroblast growth factor receptor (FGFR) FGF/FGFR alterations |
Cholangiocarcinoma Adenocarcinoma Carcinoma |
Neoplasms, Glandular and Epithelial Neoplasms by Histologic Type Neoplasms |