A Study to Evaluate the Efficacy and Safety of Pemigatinib Versus Chemotherapy in Unresectable or Metastatic Cholangiocarcinoma (FIGHT-302)

 Bile Duct Cancers / Posted 3 weeks ago

The purpose of this study is to evaluate the efficacy and safety of pemigatinib versus gemcitabine plus cisplatin chemotherapy in first-line treatment of participants with unresectable or metastatic cholangiocarcinoma with FGFR2 rearrangement.

  • Inclusion Criteria :
    • Male and female participants at least 18 years of age at the time of signing the informed consent form (ICF); a legally minor participant from Japan needs written parental consent.
    • Histologically or cytologically confirmed cholangiocarcinoma that is previously untreated and considered unresectable and/or metastatic (Stage IV per the American Joint Committee on Cancer (AJCC) Cancer Staging Manual).
    • Radiographically measurable or evaluable disease by CT or MRI per RECIST v1.1 criteria.
    • Eastern Cooperative Oncology Group performance status 0 to 1.
    • Documented FGFR2 rearrangement.
    • Willingness to avoid pregnancy or fathering children.
  • Exclusion Criteria :
    • Received prior anticancer systemic therapy for unresectable and/or metastatic disease (not including adjuvant/neo-adjuvant treatment completed at least 6 months prior to enrollment, and participants that have received treatment for locally advanced disease with trans-arterial chemoembolization or selective internal radiation therapy, if clear evidence of radiological progression is observed before enrollment).
    • Child-Pugh B and C.
    • Toxicities related to prior therapy(ies) must be Common Terminology Criteria for Adverse Events (CTCAE) v5.0 ≤ Grade 1 at the time of screening.
    • Concurrent anticancer therapy, other than the therapies being tested in this study.
    • Participant is a candidate for potentially curative surgery.
    • Current evidence of clinically significant corneal (including but not limited to bullous/band keratopathy, corneal abrasion, inflammation/ulceration, and keratoconjunctivitis) or retinal disorder (including but not limited to central serous retinopathy, macular/retinal degeneration, diabetic retinopathy, retinal detachment) as confirmed by ophthalmologic examination.
    • Radiation therapy administered within 4 weeks of enrollment/randomization/first dose of study treatment.
    • Known central nervous system (CNS) metastases or history of uncontrolled seizures.
    • Known additional malignancy that is progressing or requires active treatment (exceptions: basal cell carcinoma of the skin, squamous cell carcinoma of the skin, or in situ cervical cancer that has undergone potentially curative therapy).
    • Laboratory values at screening outside the protocol-defined range.
    • History of calcium and phosphate hemostasis disorder or systemic mineral imbalance with ectopic calcification of soft tissues (exception: commonly observed calcifications in soft tissues, such as the skin, kidney, tendons or vessels due to injury, disease, and aging, in the absence of systemic mineral imbalance).
    • Significant gastrointestinal disorders that could interfere with absorption, metabolism, or excretion of pemigatinib.
    • Clinically significant or uncontrolled cardiac disease.
    • History or presence of an abnormal ECG, which, in the investigator's opinion, is clinically meaningful.
    • Chronic or current active infectious disease requiring systemic antibiotics or antifungal or antiviral treatment within 2 weeks prior to enrollment (participants with asymptomatic chronic infections on prophylactic treatment are allowed). Note: HIV-positive participants are allowed if all of the following criteria are met: CD4+ count ≥ 300/µL, undetectable viral load, receiving antiretroviral therapy that does not interact with study drug, and no HIV/AIDS-associated opportunistic infection in the last 12 months.
    • Use of any potent CYP3A4 inhibitors or inducers or moderate CYP3A4 inducers within 14 days or 5 half-lives (whichever is longer) before the first dose of study treatment. Note: Moderate CYP3A4 inhibitors are not prohibited
    • Known hypersensitivity or severe reaction to pemigatinib, gemcitabine, cisplatin, or their excipients.
    • Inadequate recovery from toxicity and/or complications from a major surgery before starting therapy.
  • Study end date : 28/06/2026
  • Wales-Based Study Contact : Velindre Cancer Centre
  • Principal Investigator : Peter Langmuir, MD Incyte Corporation
Contact details

Velindre Cancer Centre Cardiff, United Kingdom, CF14 2TL and United Kingdom WideVelindre Cancer Centre,Cardiff medinfo@incyte.com

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