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

Phase 2

Completed

• Conditions: Colorectal Cancer
• Interventions: Drug: MB-6; Drug: Placebo

• Registration Number: NCT01047475
• Lead Sponsor: Microbio Co Ltd

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2009-10
• Study First Submitted: 2009-12-22
• Study First Submitted QC: 2010-01-12
• Study First Posted: 2010-01-13
• Primary Completion: 2011-04
• Study Completion: 2011-12
• Status Verified: 2015-04
• Results First Submitted: 2015-04-28
• Results First Submitted QC: 2015-04-28
• Last Update Submitted: 2015-04-28
• Results First Posted: 2015-05-13
• Last Update Posted: 2015-05-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 72

Inclusion Criteria

1. Patient with histologically confirmed colorectal cancer and/or clinical evidence of metastasis;
2. At least one measurable lesion either by computer tomography (CT) scan or magnetic resonance imaging (MRI);
3. Aged 20 years old or above;
4. Eastern Cooperative Oncology Group (ECOG) performance status < 2;
5. Adequate bone marrow reserve (hemoglobin > 9 g/dl, absolute neutrophil count > 1.5 x 109/L, platelets > 100 x 109/L);
6. 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;
7. Patients willing to participate in the trial and giving written informed consent.

Exclusion Criteria

1. Pregnant or lactating patients;
2. Patients (male or female) with reproductive potential not using adequate contraceptive measures;
3. Patients with evidence of central nervous system metastasis;
4. Subject with active infection which requires systemic treatment of antibiotic, antifungal, or antiviral agents
5. Current history of chronic diarrhea;
6. Other serious illness or medical conditions (e.g.: history of angina, myocardial infarction);
7. History of second primary malignancies except for adequately treated basal cell carcinoma of the skin or carcinoma in situ of the cervix;
8. Concurrent treatment with any other anticancer therapy;
9. 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;
10. Patients treated with another investigational drug within 4 weeks of entry into this study.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
MB-6+FOLFOX4	MB-6	MB-6 6 capsules tid be taken with meals plus FOLFOX4, will be given for 16 weeks
Placebo+FOLFOX4	Placebo	Placebo, 6 capsules tid be taken with meals plus FOLFOX4, will be given for 16 weeks

Primary Outcome Measures

Name	Time	Method
The Primary Efficacy Endpoint of This Study is the Best Overall Response (Complete Response + Partial Response)	16 weeks	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.

Trial Locations

Locations (1)

Microbio Co., Ltd.; 🇨🇳 Taipei, Taiwan