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A Study of Selective HDAC6 Inhibition With KA2507 in Advanced Biliary Tract Cancer

Biliary Tract Cancer Clinical Trial

Official title:
A Phase II Study of Selective HDAC6 Inhibition With KA2507 in Advanced Biliary Tract Cancer Previously Treated With Standard of Care Chemotherapy (ABC-11)

Clinical Trial Summary

To evaluate the preliminary efficacy of KA2507 (an orally active potent and selective HDAC6 inhibitor) in patients with advanced biliary tract cancer (BTC) previously treated with standard of care chemotherapy.

Clinical Trial Description

To evaluate the efficacy of KA2507 (an orally active potent and selective HDAC6 inhibitor) in patients with advanced biliary tract cancer (BTC) previously treated with standard of care chemotherapy. ABC-11 is an open-label, multi-centre study of HDAC6 inhibition using KA2507 in patients with advanced biliary tract cancer previously treated with standard of care chemotherapy. This is a single-arm single-stage phase II study designed using A'Hern's methodology. The primary objective of this study is to assess the preliminary efficacy of KA2507 in patients with advanced BTC previously treated with standard of care chemotherapy A fixed daily dose of KA2507 (800mg BID) will be administered to all patients based on a phase I study, KTP-003. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT04186156
Study type Interventional
Source Karus Therapeutics Limited
Contact
Status Withdrawn
Phase Phase 2
Start date March 5, 2020
Completion date October 2023
View Details
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