NCT05281276

Chidamide + Celecoxib in Advanced Metastatic Colorectal Cancer (CCmCC)

A Phase Ib Study of Chidamide in Combination With Celecoxib in Patients With Metastatic Colorectal Cancer Who Had Progression or Were Intolerant of at Least Two Lines of Systemic Therapies (CCmCC)

• Status: Terminated
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 9 (actual)
• Sponsor: Taipei Medical University Shuang Ho Hospital · Academic / Other
• Sex: All
• Age: 20 Years
• Healthy volunteers: Not accepted

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.

Detailed 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.

Conditions

• Metastatic Colorectal Cancer

Interventions

Type	Name	Description
DRUG	chidamide	During the run-in period, the patients will take a single dose of chidamide on Day 3. In a 28-day treatment cycle, the dosing schedule is four/six table (20/30mg) BIW .
DRUG	celecoxib	During the run-in period, the patients will take a single dose of celecoxib on Day 1. In a treatment cycle, the dosing schedule is one capsule(200 mg) daily.

Timeline

• Start date: 2022-09-20
• Primary completion: 2024-03-26
• Completion: 2024-03-26
• First posted: 2022-03-16
• Last updated: 2024-12-20

Locations

1 site across 1 country: Taiwan