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Title:
J18160 - 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)
Protocol Number:
J18160
Phase:
Phase III
Physician:
Adrian Murphy
Sites:
Johns Hopkins Kimmel Cancer Center in Baltimore
Purpose:
Evaluate the efficacy of pemigatinib versus gemcitabine plus cisplatin in the first-line treatment of participants with cholangiocarcinoma with FGFR2 rearrangement.
Eligibility:
Must be 18 years or older and have histologically or cytologically confirmed cholangiocarcinoma that is previously untreated and considered unresectable and/or metastatic. Radiographically measurable or evaluable disease by CT or MRI per RECIST v1.1 criteria and documented FGFR2 rearrangement. No prior anticancer systemic therapy for unresectable and/or metastatic disease (not including adjuvant/neo-adjuvant treatment completed at least 6 months prior to enrollment. No concurrent anticancer therapy (eg, chemotherapy, radiation therapy, surgery, immunotherapy, biologic therapy, hormonal therapy, investigational therapy, or tumor embolization), other than the therapies being tested in this study. Must not have current evidence of clinically significant corneal or retinal disorder. Must not have had radiation therapy administered within 4 weeks of enrollment. No known CNS metastases or history of uncontrolled seizures.
Treatment:
There are two treatment groups on this study. Subjects will be randomized to either treatment group A or treatment group B. Subjects on treatment group A will receive pemigantinib as continuous therapy schedule and subjects on treatment group B will receive gemcitabine and cisplatin administered as an intravenous infusion on days 1 and 8 of every 3 week cycle for up to 8 cycles
Population:
Adult
Last Update
08/08/2020 05:02 AM