Efficacy and Safety of Pemigatinib in Participants With Solid Tumors With FGFR Mutations or Translocations (FIGHT-208)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT04003623|
Recruitment Status : Active, not recruiting
First Posted : July 1, 2019
Last Update Posted : July 16, 2021
|Condition or disease||Intervention/treatment||Phase|
|Advanced or Metastatic Solid Tumors FGFR Mutations FGFR Translocations||Drug: Pemigatinib||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||50 participants|
|Intervention Model:||Single Group Assignment|
|Intervention Model Description:||Participants will be assigned to 1 of 2 cohorts (Cohort A: FGFR1-3 in-frame fusions or FGFR2 intron 17 rearrangements; Cohort B: Known/predicted activating point mutations in FGFR1-3 [excluding kinase domain]) but there is no difference in the treatment regimen between the cohorts.|
|Masking:||None (Open Label)|
|Official Title:||A Phase 2, Open-Label, Single-Arm, Multicenter Study to Evaluate the Efficacy and Safety of Pemigatinib in Participants With Previously Treated Locally Advanced/Metastatic or Surgically Unresectable Solid Tumors Harboring Activating FGFR Mutations or Translocations (FIGHT-208)|
|Actual Study Start Date :||October 31, 2019|
|Estimated Primary Completion Date :||October 31, 2021|
|Estimated Study Completion Date :||April 30, 2022|
Pemigatinib administered orally once daily.
Other Name: INCB054828
- Objective response rate (ORR) [ Time Frame: Up to approximately 6 months ]Defined as the proportion of participants in each cohort who achieve a complete response (CR) or partial response (PR) based on Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1)
- Progression-free survival (PFS) [ Time Frame: Up to approximately 6 months ]Defined as the time from first dose until progressive disease (per RECIST v1.1 or Response Assessment in Neuro-Oncology [RANO]) or death (whichever is first) in each cohort.
- Duration of response (DOR) [ Time Frame: Up to approximately 6 months ]Defined as the time from the date of first assessment of CR or PR until the date of the first progressive disease (per RECIST v1.1 or RANO) or death (whichever is first) in each cohort.
- Disease control rate (DCR) [ Time Frame: Up to approximately 6 months ]Defined as the proportion of participants who achieved best overall response of CR, PR, or stable disease per RECIST v1.1 or RANO.
- Overall survival (OS) [ Time Frame: Up to approximately 6 months ]Defined as the time from first dose of study drug to death of any cause in each cohort.
- Number of treatment-related adverse events [ Time Frame: Up to approximately 6 months ]Adverse events reported for the first time or worsening of a pre-existing event after first dose of study drug/treatment.
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): NCT04003623
|United States, California|
|Compassionate Cancer Care Medical Group|
|Fountain Valley, California, United States, 92708|
|United States, Florida|
|Ocala Oncology Center|
|Ocala, Florida, United States, 34474|
|United States, Hawaii|
|Hawaii Cancer Care|
|Honolulu, Hawaii, United States, 96813|
|United States, Illinois|
|Illinois Cancer Care|
|Peoria, Illinois, United States, 61615|
|United States, Maryland|
|FMH James M Stockman Cancer Institute|
|Frederick, Maryland, United States, 21702|
|United States, New Jersey|
|New Jersey Cancer Care and Blood Disorders|
|Belleville, New Jersey, United States, 07109|
|United States, Ohio|
|Cincinnati, Ohio, United States, 45220|
|United States, South Dakota|
|Sanford Cancer Center|
|Sioux Falls, South Dakota, United States, 51704|
|United States, Texas|
|Mary Crowley Cancer Center|
|Dallas, Texas, United States, 75230|
|Houston, Texas, United States, 77030|
|United States, Utah|
|Utah Cancer Specialists|
|Salt Lake City, Utah, United States, 84106|
|Study Director:||Incyte Medical Monitor||Incyte Corporation|