Colorectal Cancer Clinical Trial
Official title:
A Phase 1b Study of the OxPhos Inhibitor ME-344 Combined With Bevacizumab in Previously Treated Metastatic Colorectal Cancer
Verified date | March 2024 |
Source | MEI Pharma, Inc. |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Active, not recruiting |
Enrollment | 40 |
Est. completion date | June 30, 2024 |
Est. primary completion date | April 30, 2024 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - Age =18 years - Histological or cytological documentation of adenocarcinoma of the colon or rectum that is metastatic (all other histological types are excluded) - Subjects who progressed or demonstrated intolerability to prior standard approved therapies which include fluoropyrimidine, oxaliplatin, and irinotecan-based chemotherapies, cetuximab/panitumumab (if clinically indicated e.g., RAS wild-type tumors) PD-1 or BRAF inhibitors (if clinically indicated), and/or other checkpoint inhibitors in the metastatic setting. - Previous treatment with any investigational drug or anticancer treatment must be completed >28 days or 5 half-lives, whichever is longer, before the first dose of study treatment. - Adequate bone marrow, liver, and renal function Exclusion Criteria: - Untreated brain metastases, spinal cord compression, or primary brain tumor - Symptomatic brain metastases, leptomeningeal disease, spinal cord compression, or primary brain tumor - Evidence of uncontrolled or unstable cardiovascular disease, myocardial infarction (within 6 months), unstable angina pectoris, congestive heart failure, serious arrhythmias requiring drug therapy - History of CNS disease - Bevacizumab or aflibercept therapy = 3 weeks prior to starting study treatment - Peripheral neuropathy Grade = 2 - Uncontrolled hypertension or diabetes mellitus, active peptic ulcers, unhealed wounds, clinically significant disease or systemic infections - Known seropositive for, or active infection with hepatitis B or C virus - Symptomatic or uncontrolled infection with human T-cell leukemia virus - Venous thromboembolism (unless appropriately treated and stable on anticoagulant for at least 2 weeks). |
Country | Name | City | State |
---|---|---|---|
United States | Johns Hopkins | Baltimore | Maryland |
United States | University of Southern California | Los Angeles | California |
United States | Mount Sinai Miami | Miami Beach | Florida |
United States | Vanderbilt -Ingram Cancer Center | Nashville | Tennessee |
United States | Rutgers University | New Brunswick | New Jersey |
United States | Mt Sinai New York | New York | New York |
United States | University of Utah | Salt Lake City | Utah |
Lead Sponsor | Collaborator |
---|---|
MEI Pharma, Inc. |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Progression Free Survival (PFS) rate at 16 weeks | This will be measured using the Kaplan Meir (KM) method, and calculated from day of first study drug until observation of disease progression. | 16 weeks | |
Secondary | Overall Response Rate (ORR) | This will be measure by the proportion of patients achieving complete response [CR] or partial response [PR] per RECIST v.1.1). | 6 months | |
Secondary | Safety and tolerability of ME-344 administered in combination with bevacizumab | This will be measured by the number of participants with treatment emergent Adverse Events, with abnormal physical examination findings, abnormal vital signs, abnormal ECG QT interval and abnormal clinical laboratory results | 1 year |
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