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Clinical Trial Summary

This study is designed as an open-label, dose-escalation manner to determine the MFD of chidamide in combination with celecoxib in patients with advanced mCRC.


Clinical Trial Description

This is a monocentric, open-label, non-randomized dose feasibility study trial to characterize the safety, tolerability, pharmacokinetics, and preliminary efficacy of chidamide in combination with celecoxib in patients with advanced mCRC. Each cohort will have up to 6 subjects. Eligible patients will be assigned to 1 of up to 2 sequential cohorts. The planned dose levels of the two cohorts include (1) 20 mg chidamide plus 200 mg celecoxib; and (2) 30 mg chidamide plus 200 mg celecoxib. For each subject, the treatment period is divided into two periods, a run-in period and a combination therapy period. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT05281276
Study type Interventional
Source Taipei Medical University Shuang Ho Hospital
Contact Tsu-Yi Chao
Phone +886-970746900
Email 10575@s.tmu.edu.tw
Status Recruiting
Phase Phase 1
Start date September 20, 2022
Completion date December 31, 2024

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