A Study to Evaluate the Efficacy and Safety of Pemigatinib Versus Chemotherapy in Unresectable or Metastatic Cholangiocarcinoma - (FIGHT-302)
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|ClinicalTrials.gov Identifier: NCT03656536|
Recruitment Status : Recruiting
First Posted : September 3, 2018
Last Update Posted : May 2, 2019
|Condition or disease||Intervention/treatment||Phase|
|Unresectable Cholangiocarcinoma Metastatic Cholangiocarcinoma||Drug: Pemigatinib Drug: Gemcitabine Drug: Cisplatin||Phase 3|
Expanded Access : An investigational treatment associated with this study is no longer available outside the clinical trial. More info ...
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||432 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase 3, Open-Label, Randomized, Active-Controlled, Multicenter Study to Evaluate the Efficacy and Safety of Pemigatinib Versus Gemcitabine Plus Cisplatin Chemotherapy in First-Line Treatment of Participants With Unresectable or Metastatic Cholangiocarcinoma With FGFR2 Rearrangement (FIGHT-302)|
|Actual Study Start Date :||December 13, 2018|
|Estimated Primary Completion Date :||March 2022|
|Estimated Study Completion Date :||March 2023|
Pemigatinib at the protocol-defined dose administered orally once daily as continuous therapy schedule (a cycle is 3 weeks).
Other Name: INCB054828
Active Comparator: Gemcitabine + Cisplatin
Participants who experience disease progression while receiving gemcitabine + cisplatin or during the follow-up period and before starting a new anticancer therapy will be eligible allowed to cross over and receive pemigatinib.
Gemcitabine 1000 mg/m^2 administered as an intravenous infusion on Days 1 and 8 of every 3-week cycle for up to 8 cycles.
Cisplatin 25 mg/m^2 administered as an intravenous infusion on Days 1 and 8 of every 3-week cycle for up to 8 cycles.
- Progression-free survival [ Time Frame: Up to approximately 12 months ]Defined as the time from date of randomization until date of disease progression (according to Response Evaluation Criteria in Solid Tumors [RECIST] v1.1 and assessed by an independent central reviewer (ICR)) or death, whichever occurs first.
- Overall response rate [ Time Frame: Up to approximately 12 months ]Defined as the proportion of participants with best overall response of complete response (CR) or partial response (PR) per RECIST v1.1 as assessed by an ICR.
- Overall survival [ Time Frame: Up to approximately 12 months ]Defined as the time from date of randomization until death due to any cause.
- Duration of response [ Time Frame: Up to approximately 12 months ]Defined as the time from the date of the first assessment of CR or PR until the date of the first disease progression by an ICR per RECIST v1.1 or death, whichever occurs first.
- Disease control rate [ Time Frame: Up to approximately 12 months ]Defined as the proportion of participants who achieved best overall response of CR, PR, or stable disease (SD) per RECIST v1.1 as assessed by an ICR.
- Number of treatment-emergent adverse events [ Time Frame: Up to approximately 12 months ]Defined as adverse events reported for the first time or worsening of a pre-existing event after first dose of study drug.
- Quality of Life impact as assessed by the EQ-5D-3L questionnaire [ Time Frame: Up to 12 months ]
- Quality of Life impact as assessed by the European Organisation for Research and Treatment of Cancer (EORTC) QLQ-30 questionnaire [ Time Frame: Up to 12 months ]
- Quality of Life impact as assessed by the EORTC QLQ-BIL21 questionnaire [ Time Frame: Up to 12 months ]
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): NCT03656536
|Contact: Incyte Corporation Call Center (US)||email@example.com|
|Contact: Incyte Corporation Call Center (ex-US)||+800 firstname.lastname@example.org|
|United States, Florida|
|Mount Sinai Comprehensive Cancer Center||Recruiting|
|Miami Beach, Florida, United States, 33140|
|Contact: Study Coordinator 305-674-2625|
|United States, Illinois|
|The University of Chicago Medical Center||Recruiting|
|Chicago, Illinois, United States, 60637|
|Contact: Study Coordinator 773-702-7763|
|United States, Maryland|
|The Sidney Kimmel Comprehensive Cancer Center at John Hopkins||Recruiting|
|Baltimore, Maryland, United States, 21287|
|Contact: Study Coordinator 410-502-5327|
|United States, New Jersey|
|Summit Medical Group PA||Recruiting|
|Florham Park, New Jersey, United States, 07932|
|Contact: Study Coordinator 973-436-1755|
|United States, Oregon|
|Oregon Health and Science University||Recruiting|
|Portland, Oregon, United States, 97239|
|Contact: Study Coordinator 503-494-3175|
|United States, Pennsylvania|
|Fox Chase Cancer Center||Recruiting|
|Philadelphia, Pennsylvania, United States, 19111|
|Contact: Study Coordinator 215-214-1660|
|United States, South Carolina|
|Greenville Health System Cancer Institute||Recruiting|
|Greenville, South Carolina, United States, 29605|
|Contact: Study Coordinator 864-699-5731|
|United States, Washington|
|Virginia Mason Medical Center||Recruiting|
|Seattle, Washington, United States, 98101|
|Contact: Study Coordinator 206-287-5671|
|Study Director:||Luis Féliz, MD||Incyte Corporation|