Spots Global Cancer Trial Database for Chidamide + Celecoxib in Advanced Metastatic Colorectal Cancer (CCmCC)
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Trial Identification
Brief Title: Chidamide + Celecoxib in Advanced Metastatic Colorectal Cancer (CCmCC)
Official Title: 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)
Study ID: NCT05281276
Conditions
Study Description
Brief 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.
Keywords
Eligibility
Minimum Age: 20 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
Taipei Medical University Shuang Ho Hospital, New Taipei City, , Taiwan
Contact Details
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