Name: DZB-CS-301 (Formerly ARQ 087-301)

About this trial

This trial will investigate the effects of the drug derazantinib (formerly ARQ 087) in patients who have a type of bile duct cancer that cannot be operated on, or has spread, called Advanced Intrahepatic Cholangiocarcinoma. Patients must have a positive genetic test for FGFR2 Gene Fusion or FGFR2 gene mutations or amplifications and have received at least one prior regimen of systemic therapy to be eligible to participate in the trial.

Approximately 143 patients will participate in this trial internationally.
This is an open-label, single arm study meaning both the patient and study doctor are aware of the treatment being given and all patients will receive the same treatment, derazantinib.

The aim of this study is to evaluate the anti-cancer activity of the drug derazantinib. The study will evaluate the anti-tumour activity of derazantinib by progression-free survival at 3 months, overall survival, overall response rate, duration of response, quality of life and by documenting all side effects.

Patient Profile

Male or Female patients over the age of 18 with locally advanced, inoperable or metastatic Advanced Intrahepatic Cholangiocarcinoma whose tumours harbour FGFR2 gene mutations or amplifications, and who received at least one prior regimen of systemic therapy.

Where’s this trial being run?

St James’s 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

Summary Data

Name:	DZB-CS-301 (Formerly ARQ 087-301)
Number:	18-10
Full Title:	DZB-CS-301 (Formerly ARQ 087-301) A pivotal phase 2 study of derazantinib in patients with inoperable or advanced intrahepatic cholangiocarcinoma and FGFR2 gene fusions or FGFR2 gene mutations or amplifications.

Principal Investigator:	Prof Maeve Lowery (St James's Hospital)
Type:	Industry Sponsored
Sponsor:	Basilea Pharmaceutica
Recruitment Started:	Global: 10 November 2017 Ireland: 17 December 2019

Global Recruitment Target:	143
Ireland Recruitment Target:	3-5