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Clinical Trial Detail

ARQ 087 in Subjects With FGFR2 Gene Fusion Positive Inoperable or Advanced Intrahepatic Cholangiocarcinoma

Complete title: A Pivotal Trial of ARQ 087 in Subjects with FGFR2 Gene Fusion Positive Inoperable or Advanced Intrahepatic Cholangiocarcinoma

Research Study Number 20171078
 
Principal Investigator William Harris
 
Phase III

Research Study Description

This pivotal, open-label, single-arm study will evaluate the anti-cancer activity of ARQ 087 by Objective Response Rate (ORR) by central radiology review as per RECIST v1.1 in subjects with inoperable or advanced intrahepatic cholangiocarcinoma (iCCA) whose tumors harbor FGFR2 gene fusions (by FISH performed by the central laboratory) and who received at least one prior regimen of systemic therapy. Subjects will be dosed orally once per day at 300 mg of ARQ 087 capsules.

Eligibility Criteria (must meet the following to participate in this study)

** For Eligibility information, please click on the "Look up trial at NIH" link above. **

Other eligibility criteria may apply.

Research Study Number 20171078
 
Contact Seattle Cancer Care Alliance Intake Office
 
Telephone 800-804-8824 / 206-606-1024
 

Keywords: Bile Duct Cancer; Liver Cancer; Solid Tumors; Neoplasms, Glandular and Epithelial; Adenocarcinoma; Carcinoma, Hepatocellular; Cholangiocarcinoma; Digestive System Diseases; Biliary Tract Neoplasms

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