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)
To study the good and bad effects of INCB054828 vs gemcitabine plus cisplatin chemotherapy in participants with unresectable or metastatic cholangiocarcinoma with FGFR2 rearrangement who have not received treatment.
INCB054828, Cholangiocarcinoma, chemotherapy
-Histologically or cytologically confirmed cholangiocarcinoma that is previously untreated and considered unresectable and/or metastatic (Stage IV)
-Documented FGFR rearrangement
-No prior anticancer systemic therapy for unresectable and/or metastatic disease
18 - 120
Healthy Volunteers Needed
Duration of Participation
You will receive the study drug until your disease worsens, you have unacceptable side effects, or you withdraw from the study; or chemotherapy for up to 24 weeks or until your disease worsens, you have unacceptable side effects, or you withdraw from the study. After you finish dosing, your investigator will continue to watch you for side effects and follow your condition until your disease worsens, you start a new anticancer therapy, you withdrawal consent, or the end of the study, whichever occurs first.
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