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)

  • End date
    Jun 25, 2022
  • participants needed
  • sponsor
    Incyte Corporation
Updated on 1 April 2021
Incyte Corporation Call Center
Primary Contact
Institut Universitaire du Cancer de Toulouse Oncopole (0.5 mi away) Contact
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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.

Condition Solid Tumor Malignancy
Treatment pemigatinib
Clinical Study IdentifierNCT03822117
SponsorIncyte Corporation
Last Modified on1 April 2021


Yes No Not Sure

Inclusion Criteria

Histologically or cytologically confirmed solid tumor malignancy that is advanced or metastatic or is surgically unresectable
Radiographically measurable disease (per RECIST v1.1 or RANO for primary brain tumors). Tumor lesions located in a previously irradiated area or in an area subjected to other loco-regional therapy are considered measureable if progression has been clearly demonstrated in the lesion
Documentation of an FGFR1-3 gene mutation or translocation
Objective progression after at least 1 prior therapy and no therapy available that is likely to provide clinical benefit. Participants who are intolerant to or decline the approved therapy are eligible only if they have no therapy available that is likely to provide clinical benefit
Eastern Cooperative Oncology Group performance status 0 to 2
Baseline archival tumor specimen (if less than 24 months from date of screening) or willingness to undergo a pretreatment tumor biopsy to obtain the specimen. Must be a tumor block or approximately 15 unstained slides from biopsy or resection of primary tumor or metastasis
Willingness to avoid pregnancy or fathering children

Exclusion Criteria

Prior receipt of a selective FGFR inhibitor in the past 6 months
Receipt of anticancer medications or investigational drugs for any indication or reason within 28 days before first dose of pemigatinib
Cannot be a candidate for potentially curative surgery
Current evidence of clinically significant corneal or retinal disorder as confirmed by ophthalmologic examination
Radiation therapy administered within 2 weeks of enrollment/first dose of study treatment
Untreated brain or central nervous system (CNS) metastases or brain or CNS metastases that have progressed (eg, evidence of new or enlarging brain metastasis or new neurological symptoms attributable to brain or CNS metastases)
Known additional malignancy that is progressing or requires active treatment
History of calcium and phosphate hemostasis disorder or systemic mineral imbalance with ectopic calcification of soft tissues
Clinically significant or uncontrolled cardiac disease
Active chronic or current infectious disease requiring systemic antibiotic, antifungal, or antiviral treatment within 2 weeks before enrollment (participants with asymptomatic chronic infections on prophylactic treatment are allowed)
Evidence of active hepatitis B virus (HBV) or hepatitis C virus (HCV) infection (defined as elevated transaminases or cirrhosis; chronic HBV/HCV infection with no cirrhosis and no elevated transaminases is allowed)
Known HIV infection
Use of any potent CYP3A4 inhibitors or inducers or moderate CYP3A4 inducers within 14 days or five half-lives (whichever is longer) before the first dose of study drug/treatment
Women who are pregnant or breastfeeding
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