Pemigatinib vs Chemotherapy for Bile Duct Cancer
(FIGHT-302 Trial)

Recruiting in Palo Alto (17 mi)

+278 other locations

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 3

Waitlist Available

Sponsor: Incyte Corporation

No Placebo Group

Pivotal Trial (Near Approval)

Prior Safety Data

Breakthrough Therapy

Trial Summary

What is the purpose of this trial?This trial is testing a new drug called pemigatinib against the usual cancer treatment. It focuses on patients with advanced bile duct cancer who have a specific change in their genes. The goal is to see if pemigatinib is more effective and safer than the usual treatment. Pemigatinib is the first of its kind approved in the US, receiving approval recently.

Eligibility Criteria

Adults with previously untreated, inoperable or metastatic cholangiocarcinoma (bile duct cancer) and confirmed FGFR2 rearrangement can join. They must have a good performance status, meaning they're relatively active and able to care for themselves. Participants should be willing to prevent pregnancy.

Inclusion Criteria

Willingness to avoid pregnancy or fathering children

My cholangiocarcinoma is in stage IV and has not been treated.

My cancer has a specific genetic change known as FGFR2 rearrangement.

+3 more

Exclusion Criteria

I have had treatment for cancer that couldn't be removed by surgery.

I have another cancer that is getting worse or needs treatment.

I have a history of calcium or phosphate balance issues leading to soft tissue calcification.

+15 more

Participant Groups

The trial is testing the effectiveness and safety of pemigatinib compared to standard chemotherapy (gemcitabine plus cisplatin). It's for first-line treatment, which means it's the first therapy given after diagnosis.

2Treatment groups

Experimental Treatment

Active Control

Group I: PemigatinibExperimental Treatment1 Intervention

Group II: Gemcitabine + CisplatinActive Control2 Interventions

Participants who experience disease progression while receiving gemcitabine + cisplatin or during the follow-up period and before starting a new anticancer therapy will be eligible to cross over and receive pemigatinib.

Cisplatin is already approved in European Union, United States, Canada, Japan for the following indications:

🇪🇺 Approved in European Union as Platinol for: