Florham Park, New Jersey 07932


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. - Must not be 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). - Gastrointestinal conditions/disorders that may raise gastric and/or small intestinal pH 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, antifungal or antiviral treatment within 2 weeks prior to enrollment. - Use of any potent CYP3A4 inhibitors or inducers within 14 days or 5 half-lives (whichever is longer) before the first dose of study treatment. - 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.



Primary Contact:

Study Director
Luis Féliz, MD
Incyte Corporation

Incyte Corporation Call Center (US)
Phone: 1.855.463.3463
Email: medinfo@incyte.com

Backup Contact:

Email: globalmedinfo@incyte.com
Incyte Corporation Call Center (ex-US)
Phone: +800 00027423

Location Contact:

Florham Park, New Jersey 07932
United States

Study Coordinator
Phone: 973-436-1755

Site Status: Recruiting

Data Source: ClinicalTrials.gov

Date Processed: February 04, 2019

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