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

  • Interventional
  • Not Recruiting
  • NCT03656536
Eligibility Details Visit Clinicaltrials.gov

A Phase 3, Open-Label, Randomized, Active-Controlled, Multicenter Study 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 (FIGHT-302)

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.

Gender
All

Age Group
18 Years and up

Accepting Healthy Volunteers?
No

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.

At a Glance

National Government IDNCT03656536

IRB#IRB18-1351

Lead SponsorIncyte Corporation

Lead PhysicianChih-Yi Liao

Collaborator(s)N/A

EligibilityAll
18 Years and up
Not Recruiting