Florham Park, New Jersey 07932


Purpose:

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.


Criteria:

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.


NCT ID:

NCT03656536


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

Modifications to this listing: Only selected fields are shown, please use the link below to view all information about this clinical trial.


Click to view Full Listing

If you would like to be contacted by the clinical trial representative please fill out the form below.