Varlitinib in Combination With Gemcitabine and Cisplatin for Treatment naïve Advanced or Metastatic BTC
Status:
Terminated
Trial end date:
2020-11-24
Target enrollment:
Participant gender:
Summary
The study intends to evaluate the following objectives in patients with advanced or
metastatic biliary tract cancer who have not received systemic therapy for
advanced/metastatic disease.
Primary Objectives:
Phase 1B
- To determine the maximum tolerated dose (MTD), as determined by dose-limiting toxicities
(DLTs), and to characterise the safety profile of Varlitinib in combination with
Gemcitabine and Cisplatin.
Phase 2A
- To further evaluate the safety and tolerability of Varlitinib in combination with
Gemcitabine and Cisplatin at the recommended phase 2 dose (RP2D).
- To provide a preliminary assessment of the clinical activity of Varlitinib in
combination with Gemcitabine and Cisplatin at the RP2D as measured by Objective Response
Rate (ORR) and progression-free survival (PFS) (based on RECIST v1.1)
Phase 2B
- To compare the efficacy of Varlitinib in combination with Gemcitabine and Cisplatin to
placebo in combination with Gemcitabine and Cisplatin as measured by progression-free
survival (based on RECIST v1.1).