A Phase II Trial of MB-6 Plus FOLFOX4 for Metastatic Colorectal Cancer (FDA IND 103675)

Study Overview
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Brief Summary
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This is a randomized, double-blind, parallel group, placebo-controlled study evaluate the preliminary efficacy and safety of MB-6 (320 mg/capsule, 6 capsules tid) versus placebo in addition to standard chemotherapy in the treatment of patients with metastatic colorectal cancer.

Official Title
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A Phase II Trial of MB-6 Plus FOLFOX4 for Metastatic Colorectal Cancer

Conditions
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Colorectal Cancer

Intervention / Treatment
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* Drug: MB-6
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patient with histologically confirmed colorectal cancer and/or clinical evidence of metastasis; At least one measurable lesion either by computer tomography (CT) scan or magnetic resonance imaging (MRI); Aged 20 years old or above; Eastern Cooperative Oncology Group (ECOG) performance status < 2; Adequate bone marrow reserve (hemoglobin > 9 g/dl, absolute neutrophil count > 1.5 x 109/L, platelets > 100 x 109/L); Adequate renal and hepatic functions: total bilirubin < 1.25 x upper normal limit, creatinine < 1.25 x upper normal limit, alanine aminotransferase (ALT) or aspartate aminotransferase (AST) < 2.5 x upper normal limit; Patients willing to participate in the trial and giving written informed consent. Exclusion Criteria: Pregnant or lactating patients; Patients (male or female) with reproductive potential not using adequate contraceptive measures; Patients with evidence of central nervous system metastasis; Subject with active infection which requires systemic treatment of antibiotic, antifungal, or antiviral agents Current history of chronic diarrhea; Other serious illness or medical conditions (e.g.: history of angina, myocardial infarction); History of second primary malignancies except for adequately treated basal cell carcinoma of the skin or carcinoma in situ of the cervix; Concurrent treatment with any other anticancer therapy; Patients with congestive heart failure (New York Heart Association Functional Classification III or IV), epilepsy, or other significant medical conditions as judged by the investigator; Patients treated with another investigational drug within 4 weeks of entry into this study.

Ages Eligible for Study
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Minimum Age: 20 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: MB-6+FOLFOX4<br>MB-6 6 capsules tid be taken with meals plus FOLFOX4, will be given for 16 weeks | Drug: MB-6<br>* 6# TID with meal<br>|
| Placebo Comparator: Placebo+FOLFOX4<br>Placebo, 6 capsules tid be taken with meals plus FOLFOX4, will be given for 16 weeks | Drug: Placebo<br>* 6# TID with meal<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The Primary Efficacy Endpoint of This Study is the Best Overall Response (Complete Response + Partial Response) | The primary efficacy analysis, the incidence of best overall response during the study period, was based on the Fisher's exact test for the binary response that was used to test for the differences in the treatment efficacy between MB-6 and Placebo. | 16 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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MB-6, FOLFOX4, Metastatic Colorectal Cancer