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

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

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.

Study Overview

• Status: Completed
• Conditions: Colorectal Cancer
• Intervention / Treatment: Drug: MB-6; Drug: Placebo

• Study Type: Interventional
• Enrollment (Actual): 72
• Phase: Phase 2

Contacts and Locations

Study Locations

• Taiwan
  • Taipei, Taiwan
    • Microbio Co., Ltd.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Microbio Co Ltd
• Investigators: Principal Investigator: William Chen, B.S., China Medical University Hospital

Study record dates

Study Major Dates

• Study Start: October 1, 2009
• Primary Completion (Actual): April 1, 2011
• Study Completion (Actual): December 1, 2011

Study Registration Dates

• First Submitted: December 22, 2009
• First Submitted That Met QC Criteria: January 12, 2010
• First Posted (Estimate): January 13, 2010

Study Record Updates

• Last Update Posted (Estimate): May 13, 2015
• Last Update Submitted That Met QC Criteria: April 28, 2015
• Last Verified: April 1, 2015

More Information

Terms related to this study

• Keywords: Metastatic Colorectal Cancer; FOLFOX4; MB-6
• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms; Neoplasms by Site; Gastrointestinal Neoplasms; Digestive System Neoplasms; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Intestinal Neoplasms; Rectal Diseases; Colorectal Neoplasms
• Other Study ID Numbers: MB104CLCT01