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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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04003623
Recruitment Status : Recruiting
First Posted : July 1, 2019
Last Update Posted : January 13, 2020
Sponsor:
Information provided by (Responsible Party):
Incyte Corporation

Study Description
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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 tumors harboring activating FGFR mutations or translocations.

Condition or disease Intervention/treatment Phase
Advanced or Metastatic Solid Tumors FGFR Mutations FGFR Translocations Drug: Pemigatinib Phase 2

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Allocation: N/A
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)
Primary Purpose: Treatment
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 2021
Estimated Study Completion Date : April 2022
Arms and Interventions
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Arm Intervention/treatment
Experimental: Pemigatinib Drug: Pemigatinib
Pemigatinib administered orally once daily.
Other Name: INCB054828


Outcome Measures
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Primary Outcome Measures :
  1. 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)


Secondary Outcome Measures :
  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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.


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

Inclusion Criteria:

  • Histologically or cytologically confirmed solid tumor malignancy that is advanced or metastatic (Stage IIIB or IV) or is surgically unresectable.
  • Radiographically measurable disease (per RECIST v1.1 or RANO for primary brain tumors).
  • Documentation of an FGFR1-3 gene mutation or translocation.
  • Objective disease progression after at least 1 prior therapy.
  • Not eligible or able to participate in any other Incyte-sponsored clinical trial.

Exclusion Criteria:

  • Advanced/metastatic bladder cancer or advanced/metastatic cholangiocarcinoma.
  • Prior receipt of a selective FGFR inhibitor.
  • Current evidence of clinically significant corneal or retinal disorder.
  • History of calcium and phosphate hemostasis disorder or systemic mineral imbalance with ectopic calcification of soft tissues.
Contacts and Locations
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Information from the National Library of Medicine

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


Contacts
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Contact: Incyte Corporation Call Center (US) 1.855.463.3463 medinfo@incyte.com
Contact: Incyte Corporation Call Center (ex-US) +800 00027423 eumedinfo@incyte.com

Locations
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United States, California
Compassionate Cancer Care Medical Group Recruiting
Fountain Valley, California, United States, 92708
United States, Florida
Ocala Oncology Center Recruiting
Ocala, Florida, United States, 34474
United States, Hawaii
Hawaii Cancer Care Recruiting
Honolulu, Hawaii, United States, 96813
United States, Illinois
Illinois Cancer Care Recruiting
Peoria, Illinois, United States, 61615
United States, Maryland
FMH James M Stockman Cancer Institute Recruiting
Frederick, Maryland, United States, 21702
United States, New Jersey
New Jersey Cancer Care and Blood Disorders Recruiting
Belleville, New Jersey, United States, 07109
United States, Ohio
TriHealth Recruiting
Cincinnati, Ohio, United States, 45220
United States, South Dakota
Sanford Cancer Center Recruiting
Sioux Falls, South Dakota, United States, 51704
United States, Texas
Mary Crowley Cancer Center Recruiting
Dallas, Texas, United States, 75230
Oncology Consultants Recruiting
Houston, Texas, United States, 77030
United States, Utah
Utah Cancer Specialists Recruiting
Salt Lake City, Utah, United States, 84106
Sponsors and Collaborators
Incyte Corporation
Investigators
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Study Director: Incyte Medical Monitor Incyte Corporation
More Information
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Responsible Party: Incyte Corporation
ClinicalTrials.gov Identifier: NCT04003623    
Other Study ID Numbers: INCB 54828-MA-TA-208
First Posted: July 1, 2019    Key Record Dates
Last Update Posted: January 13, 2020
Last Verified: January 2020

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Incyte Corporation:
Advanced solid tumor
metastatic solid tumor
FGFR inhibitor
FGFR mutation
FGFR translocation
Additional relevant MeSH terms:
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Neoplasms