IRB #

STUDY00019095

Title

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)

Principal Investigator

Charles Lopez

Study Purpose

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.

Medical Condition(s)

INCB054828, Cholangiocarcinoma, chemotherapy

Eligibility Criteria

-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

Age Range

18 - 120

Healthy Volunteers Needed

No

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.

Minors Included

No

Contact

Knight Clinical Trials Information Line
503-494-1080

Sponsor

Incyte Corporation

Recruitment End

09/01/2025

Compensation Provided

No


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