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

Trial Status: Active

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.

Arizona

Scottsdale
Mayo Clinic in Arizona
Status: ACTIVE

California

Orange
UC Irvine Health / Chao Family Comprehensive Cancer Center
Status: APPROVED

Florida

Jacksonville
Mayo Clinic in Florida
Status: ACTIVE

Georgia

Atlanta
Emory Saint Joseph's Hospital
Status: APPROVED
Emory University Hospital / Winship Cancer Institute
Status: ACTIVE
Emory University Hospital Midtown
Status: APPROVED
Johns Creek
Emory Johns Creek Hospital
Status: APPROVED

Illinois

Chicago
University of Chicago Comprehensive Cancer Center
Status: ACTIVE

Iowa

Iowa City
University of Iowa / Holden Comprehensive Cancer Center
Status: ACTIVE

Kansas

Kansas City
University of Kansas Cancer Center
Status: ACTIVE
Contact: Benjamin R. Roberts
Phone: 913-588-6939

Maryland

Baltimore
Johns Hopkins University / Sidney Kimmel Cancer Center
Status: ACTIVE

Massachusetts

Boston
Beth Israel Deaconess Medical Center
Status: ACTIVE

Michigan

Detroit
Wayne State University / Karmanos Cancer Institute
Status: ACTIVE

Minnesota

Rochester
Mayo Clinic in Rochester
Status: ACTIVE

Ohio

Cleveland
Case Comprehensive Cancer Center
Status: ACTIVE

Oregon

Portland
OHSU Knight Cancer Institute
Status: ACTIVE

Pennsylvania

Philadelphia
Fox Chase Cancer Center
Status: ACTIVE
Contact: systems coordinator
Phone: 215-214-1558

Trial Phase Phase III

Trial Type Treatment

Lead Organization
Incyte Corporation

  • Primary ID INCB 54828-302
  • Secondary IDs NCI-2019-01725
  • Clinicaltrials.gov ID NCT03656536