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Protocol No. UW20046

Principal Investigator Uboha, Nataliya

Phase II

Age Group Adult

Scope National

Sponsor Type Industry

Title A Phase 2 Study of Futibatinib in Patients with Specific FGFR Aberrations

Objective The purpose of the study is to evaluate the efficacy and safety of futibatinib in patients with any of the 3 types of tumors harboring FGFR gene rearrangements. Pharmacokinetics allows us to examine how the body processes a drug (in other words, what the body does to the drug) and pharmacodynamics allows us to find out how the body reacts to a drug (in other words, what the drug does to the body)

Treatment You will be assigned to 1 of 3 treatment groups based on your diagnosis and FGFR genetic modification. You will receive futibatinib at an oral dose of 20 mg once a day on a continuous 28-day cycle. Treatment will continue until disease progression, unacceptable toxicity, or any other of the criteria for treatment discontinuation is met

Description Phase 2 Study of Futibatinib in Patients with Specific FGFR Aberrations

Key Eligibility
  • 18 years of age or older
  • ECOG Performance status 0-1
  • Known FGFR aberration status and tumor type that meet all of the criteria for 1 of the following cohorts:
  • Cohort A: Histologically-confirmed, locally-advanced, advanced, or metastatic solid tumors harboring a FGFR1-4 rearrangement determined in tumor tissue using next-generation sequencing (NGS), fluorescence in situ hybridization (FISH), or other assays that can determine gene rearrangements in tumor tissues. Patients with primary brain tumor or iCCA are not eligible, and measurable disease per RECIST 1.1 and disease progression/recurrence after standard treatment for their advanced or metastatic cancer
  • Cohort B:Histologically-confirmed, locally-advanced, advanced, or metastatic gastric or GEJ cancer harboring a FGFR2 amplification. The tumor must have an FGFR2/CEN10 ratio of greater than or equal to 5 or an FGFR2 copy number greater than or equal to 10 signals per cell determined in tumor tissue using NGS, FISH, or other assays that can determine gene amplification in tumor tissues, measurable disease per RECIST 1.1,Received at least 2 prior systemic regimens for advanced/metastatic disease, Experienced disease progression/recurrence during or after the most recent prior systemic treatment for advanced/metastatic gastric or GEJ cancer
  • Cohort C: Confirmed MLN with a FGFR1 rearrangement as defined by WHO criteria, not a candidate for hematological stem cell transplant (HSCT) or relapsed after HSCT and donor lymphocyte infusion, and progressed and not a candidate for other therapies
  • Archival or fresh tumor tissue (preferably in block format) available to send to central laboratory
  • Adequate organ function as defined by the protocol
  • Can not be pregnant or breastfeeding
  • Male and Female of child bearing potential must agree to adequate birth control as defined by the protocol
  • Ability to take medications orally (feeding tube is not permitted)
  • Willing and able to comply with scheduled visits and study procedures
  • Currently receiving an investigational drug in a clinical trial
  • Received strong inhibitors and inducers of CYP3A4 within 2 weeks of first dose
  • Prior treatment with an FGFR inhibitor
  • Serious illness or medical condition(s) as defined by the protocol
  • Active central nervous system (CNS) metastasis and/or carcinomatous meningitis. Patients with previously treated brain metastases that are clinically and radiologically stable (for at least 4 weeks prior to enrollment) are eligible
  • History and/or current evidence of any of the following disorders: Non-tumor related alteration of the calcium-phosphorus homeostasis that is considered clinically significant in the opinion of the Investigator, Ectopic mineralization/calcification including, but not limited to, soft tissue, kidneys, intestine, or myocardia and lung, considered clinically significant in the opinion of the Investigator, retinal or corneal disorder confirmed by retinal/corneal examination and considered clinically significant in the opinion of the Investigator
  • Treatment with any of the following within the specified time frame prior to the first dose of futibatinib: Major surgery within 4 weeks (surgical incision should be fully healed), Radiotherapy for extended field within 4 weeks or limited field radiotherapy within 2 weeks, A drug that has not received regulatory approval for any indication within 14 or 21 days of treatment for a nonmyelosuppressive or myelosuppressive agent, respectively
  • Corrected QT interval using Fridericia’s formula (QTcF) greater than 470 msec. Patients with an atrioventricular pacemaker or other condition (for example, right bundle branch block) that renders the QT measurement invalid are an exception and the criterion does not apply

  • Applicable Disease Sites Breast; Gastrointestinal cancers, other; Genitourinary cancers, other; Unknown Sites

    Status Open

    Participating Institutions UW Hospital and Clinics