INCB 54828-302

About this trial

The purpose of this trial is to evaluate the efficacy of pemigatinib compared to standard chemotherapy (Gemcitabine Plus Cisplatin) in the first-line treatment of patients with a type of the bile duct cancer (Cholangiocarcinoma) that is not amenable to surgery and/or has spread. All potential patients must have documented FGFR2 gene rearrangement by genetic testing.

Approximately 432 patients will participate in this trial internationally.
This is an open label randomised trial. This means that both the patient and their study doctor will know which treatment they are receiving. Patients will be randomly assigned to one of the two treatment groups. 50% of patients will receive the study drug, pemigatinib, and 50% of patients will receive gemcitabine and cisplatin chemotherapy which is the standard treatment for patients with unresectable and/or metastatic cholangiocarcinoma.

The main aims of this trial are to compare progression-free survival and overall survival between the two groups. Other aims of this trial include comparing the overall response rate and duration of response to treatment between the two groups, documenting side effects to treatment and comparing Quality of Life between the two groups.

Patient Profile

Male and female participants at least 18 years of age who have unresectable and/or metastatic cholangiocarcinoma with FGFR2 rearrangement

Where’s this trial being run?

St Vincents University Hospital

Can I join this study / trial?

The first thing you do is to talk to your doctor and/or the cancer trials research team in your hospital. The contact details for the cancer trials research units in Ireland is here.

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Questions?

Here’s a list of questions you may have for your doctor or local cancer research team.

Questions

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Summary Data

Name:	INCB 54828-302
Number:	18-45
Full Title:	INCB 54828-302 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:	Prof Ray McDermott (SVUH)
Type:	Industry Sponsored
Sponsor:	Incyte Corporation
Recruitment Started:	Global: 13 December 2018 Ireland: 16 December 2019

Global Recruitment Target:	432
Ireland Recruitment Target: