A Multi-Center Randomized Phase IB/II Study of Gemcitabine and Cisplatin With or Without CPI-613 as First Line Therapy for Patients With Advanced Unresectable Biliary Tract Cancer (BilT-04)

Status: Completed

Phase of Trial: Phase I/II

Latest Information Update: 19 Jul 2024

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Drugs Cisplatin (Primary) ; Devimistat (Primary) ; Gemcitabine (Primary)
Indications Biliary cancer; Carcinoma; Cholangiocarcinoma; Gallbladder cancer
Focus Adverse reactions; Therapeutic Use
Acronyms BilT-04

11 Jul 2024 Status changed from active, no longer recruiting to completed.
05 Jun 2024 Planned End Date changed from 1 Nov 2025 to 1 May 2025.
04 Jun 2024 Primary endpoint (Phase 2: Overall Response Rate (ORR) has not been met, according to Results presented at the 60th Annual Meeting of the American Society of Clinical Oncology.

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