ME-344 and Bevacizumab in Previously Treated Metastatic Colorectal Cancer
Part of paid clinical trials in Los Angeles, California.
- Sponsor
- MEI Pharma, Inc.
- Study ID
- NCT05824559
- Phase
- PHASE1
- Status
- Terminated
Conditions
Eligibility Criteria
- Sex
- ALL
- Age
- 18 Years - N/A
- Healthy Volunteers
- Not accepted
Interventions
- ME-344 — DRUGME-344 will be administered intravenously (IV)
- Bevacizumab — DRUGBevacizumab will be administered intravenously (IV)
Study Details
This is a Phase 1b open-label, multiple dose/schedule sequential study to determine the safety and efficacy of the oxidative phosphorylation (OxPhos) pathway inhibitor ME-344 in combination with bevacizumab in subjects with recurrent mCRC.
Key Dates
- First listed
- Apr 21, 2023
- Start date
- Aug 7, 2023
- Status verified
- Jun 2024
- Primary completion
- Jul 9, 2024
- Completion
- Jul 23, 2024
Study Design
- Enrollment
- 23 participants (actual)
- Allocation
- NA
- Intervention model
- SINGLE_GROUP
- Primary purpose
- TREATMENT
Arms
- Experimental: ME-344 and BevacizumabME-344 (IV) Cohort 1: Days 1, 8, and 15 of each 28-day cycle. Cohort 2: Days 1 and 15 of each 28-day cycle. Bevacizumab (IV) Cohorts 1 and 2: Days 1 and 15 of each 28-day cycle.
Primary Outcome Measure
Progression Free Survival (PFS) Rate at 16 Weeks [ Time Frame: 16 weeks ]
Locations (7)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| University of Southern California | Los Angeles | California | 90033 | - |
| Mount Sinai Miami | Miami Beach | Florida | 33140 | - |
| Johns Hopkins | Baltimore | Maryland | 21218 | - |
| Rutgers University | New Brunswick | New Jersey | 08901 | - |
| Mt Sinai New York | New York | New York | 10029 | - |
| Vanderbilt -Ingram Cancer Center | Nashville | Tennessee | 37232 | - |
| University of Utah | Salt Lake City | Utah | 84108 | - |
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