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Protocol No. UW19136

Principal Investigator Uboha, Nataliya

Phase II

Age Group Adult

Scope National

Sponsor Type Industry

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 Tumor Malignancies Harboring Activating FGFR Mutations or Translocations (FIGHT-207)

Objective The purpose of this Study is to compare the effects, good and/or bad, that the Study Drug has on locally advanced/metastatic or surgically unresectable solid tumor malignancy with an activating fibroblast growth factor receptor (FGFR) mutation and/or translocation
  • This Study is Open-Label, which means that, during the study, you and your Study Doctor will know what treatment you are receiving
  • In this study you and all other participants will receive Study Drug

  • Treatment Pemigatinib once a day, every day, by mouth for 3 weeks. This 3 week period is called a cycle. The cycle will be repeated until Study Drug no longer works for you.

    Description Phase II Study of Pemigatinib in patients with Solid Tumor Malignancies Harboring FGFR Mutations or Translocations

    Key Eligibility
  • Age 18 years or older 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. Participants will be assigned to 1 of 3 cohorts:
  • Cohort A: FGFR1-3 in-frame fusions or FGFR2 rearrangements
  • Cohort B: Known or likely activating mutations (excluding kinase domain) in FGFR1-3
  • Cohort C: Known activating mutations in the kinase domain of FGFR1-3, other likely activating FGFR1-3 mutations or FGFR1/FGFR3 rearrangements (requires consultation with the sponsor)
  • Only FGFR fusions or rearrangements with an intact kinase domain are eligible
  • Objective progression after at least 1 prior therapy, and must have no therapy available that is likely to provide clinical benefit
  • ECOG performance status 0 to 2
  • Archival tumor specimen (if less than 12 months from date of screening) or willingness to undergo a pretreatment tumor biopsy to obtain the specimen
  • Can not be pregnant or breastfeeding and must agree to adequate birth control as defined by the protocol
  • Adequate hematologic, renal, hepatic and kidney function as defined by the protocol
    EXCLUSION
  • Prior receipt of a selective FGFR inhibitor
  • Candidate for potentially curative surgery
  • Current evidence of clinically significant corneal or retinal disorder as defined by the protocol
  • Untreated brain or CNS metastases or brain or CNS metastases that have progressed
  • Gastrointestinal condition/disorders that may raise gastric and/or small intestinal pH that could interfere with absorption, metabolism, or excretion of pemigatinib
  • Inability to swallow and retain oral medication
  • Clinically significant or uncontrolled cardiac disease as defined by the protocol
  • History or presence of an abnormal ECG that, in the investigator's opinion, is clinically meaningful
  • Active chronic or current infectious disease requiring systemic antibiotic, antifungal, or antiviral treatment within 2 weeks before enrollment
  • Evidence of active HBV or HCV infection or known HIV infection
  • Current use of prohibited medication as defined by the protocol
  • History of hypovitaminosis D requiring supraphysiologic doses (eg, 50,000 UI/weekly) to replenish the deficiency. Vitamin D supplements are allowed
  • Inability or unlikeliness of the participant to comply with the dose schedule and study evaluations, in the opinion of the investigator

  • Applicable Disease Sites Anal; Any Site; Bladder; Brain/Central Nervous System; Breast; Cervix; Colon and Rectum; Endocrine cancers; Esophagus; Gastrointestinal cancers, other; Genitourinary cancers, other; Head and Neck; Ill-Defined Sites; Kidney; Liver; Lung; Melanoma/Skin cancer; Ovary; Pancreas; Prostate; Sarcoma; Stomach; Thyroid; Unknown Sites; Uterus

    Status Open

    Participating Institutions UW Hospital and Clinics