Efficacy and Safety of Pemigatinib in Previously Treated Locally Advanced/Metastatic or Surgically Unresectable Solid Tumor Malignancies Harboring Activating FGFR Mutations or Translocations (FIGHT-207)
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ClinicalTrials.gov Identifier: NCT03822117 |
Recruitment Status :
Terminated
(A business decision was made to to discontinue further enrollment. There were no safety concerns that contributed to this decision.)
First Posted : January 30, 2019
Last Update Posted : June 21, 2022
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Tracking Information | |||||||||||||||
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First Submitted Date ICMJE | January 28, 2019 | ||||||||||||||
First Posted Date ICMJE | January 30, 2019 | ||||||||||||||
Last Update Posted Date | June 21, 2022 | ||||||||||||||
Actual Study Start Date ICMJE | October 17, 2019 | ||||||||||||||
Actual Primary Completion Date | March 29, 2022 (Final data collection date for primary outcome measure) | ||||||||||||||
Current Primary Outcome Measures ICMJE |
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Original Primary Outcome Measures ICMJE | Same as current | ||||||||||||||
Change History | |||||||||||||||
Current Secondary Outcome Measures ICMJE |
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Original Secondary Outcome Measures ICMJE | Same as current | ||||||||||||||
Current Other Pre-specified Outcome Measures | Not Provided | ||||||||||||||
Original Other Pre-specified Outcome Measures | Not Provided | ||||||||||||||
Descriptive Information | |||||||||||||||
Brief Title ICMJE | Efficacy and Safety of Pemigatinib in Previously Treated Locally Advanced/Metastatic or Surgically Unresectable Solid Tumor Malignancies Harboring Activating FGFR Mutations or Translocations (FIGHT-207) | ||||||||||||||
Official Title ICMJE | 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 Tumor Malignancies Harboring Activating FGFR Mutations or Translocations (FIGHT-207) | ||||||||||||||
Brief Summary | The purpose of this study is to evaluate the efficacy and safety of pemigatinib in participants with previously treated locally advanced/metastatic or surgically unresectable solid tumor malignancies harboring activating FGFR mutations or translocations. | ||||||||||||||
Detailed Description | Not Provided | ||||||||||||||
Study Type ICMJE | Interventional | ||||||||||||||
Study Phase ICMJE | Phase 2 | ||||||||||||||
Study Design ICMJE | Allocation: N/A Intervention Model: Single Group Assignment Intervention Model Description: This study consists of 3 cohorts that will have study drug administered in parallel, Cohort A, Cohort B, and Cohort C. There is no difference in the treatment regimen between the cohorts. Masking: None (Open Label)Primary Purpose: Treatment |
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Condition ICMJE | Solid Tumor Malignancy | ||||||||||||||
Intervention ICMJE | Drug: Pemigatinib
Pemigatinib administered orally once daily (QD).
Other Name: INCB054828
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Study Arms ICMJE | Experimental: Pemigatinib
Cohort A (Solid tumor malignancies with FGFR1-3 in frame fusions; any FGFR2 rearrangement; FGFR1/3 rearrangement with known partner*). Cohort B (Solid tumor malignancies with known or likely activating mutations (excluding kinase domain) in FGFR1-3) Cohort C (Solid tumor malignancies with FGFR1-3 known activating mutations in kinase domain; FGFR1-3 putatively activating mutations; other FGFR1/3 rearrangements* (not eligible for Cohort A)). *Only FGFR fusions or rearrangements with an intact kinase domain are eligible Intervention: Drug: Pemigatinib
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Publications * | Not Provided | ||||||||||||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |||||||||||||||
Recruitment Status ICMJE | Terminated | ||||||||||||||
Actual Enrollment ICMJE |
111 | ||||||||||||||
Original Estimated Enrollment ICMJE |
170 | ||||||||||||||
Actual Study Completion Date ICMJE | March 29, 2022 | ||||||||||||||
Actual Primary Completion Date | March 29, 2022 (Final data collection date for primary outcome measure) | ||||||||||||||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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Sex/Gender ICMJE |
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Ages ICMJE | 18 Years and older (Adult, Older Adult) | ||||||||||||||
Accepts Healthy Volunteers ICMJE | No | ||||||||||||||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||||||||||||
Listed Location Countries ICMJE | Denmark, France, Germany, Israel, Italy, Japan, Korea, Republic of, Spain, Switzerland, United Kingdom, United States | ||||||||||||||
Removed Location Countries | |||||||||||||||
Administrative Information | |||||||||||||||
NCT Number ICMJE | NCT03822117 | ||||||||||||||
Other Study ID Numbers ICMJE | INCB 54828-207 | ||||||||||||||
Has Data Monitoring Committee | Yes | ||||||||||||||
U.S. FDA-regulated Product |
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IPD Sharing Statement ICMJE |
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Current Responsible Party | Incyte Corporation | ||||||||||||||
Original Responsible Party | Same as current | ||||||||||||||
Current Study Sponsor ICMJE | Incyte Corporation | ||||||||||||||
Original Study Sponsor ICMJE | Same as current | ||||||||||||||
Collaborators ICMJE | Not Provided | ||||||||||||||
Investigators ICMJE |
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PRS Account | Incyte Corporation | ||||||||||||||
Verification Date | June 2022 | ||||||||||||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |