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

• ClinicalTrials.gov Identifier: NCT01047475
• Recruitment Status: Completed
• First Posted: January 13, 2010
• Results First Posted: May 13, 2015
• Last Update Posted: May 13, 2015
• Sponsor: Microbio Co Ltd
• Information provided by (Responsible Party): Microbio Co Ltd

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Colorectal Cancer	Drug: MB-6; Drug: Placebo	Phase 2

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 72 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Participant, Investigator)
• Primary Purpose: Treatment
• Official Title: A Phase II Trial of MB-6 Plus FOLFOX4 for Metastatic Colorectal Cancer
• Study Start Date: October 2009
• Actual Primary Completion Date: April 2011
• Actual Study Completion Date: December 2011

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures :

1. The Primary Efficacy Endpoint of This Study is the Best Overall Response (Complete Response + Partial Response) [ Time Frame: 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.

Eligibility Criteria

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

Criteria

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.

Contacts and Locations

Locations

Taiwan

Microbio Co., Ltd.

Taipei, Taiwan

Sponsors and Collaborators

Microbio Co Ltd

Investigators

• Principal Investigator: William Chen, B.S.; China Medical University Hospital

More Information

• Responsible Party: Microbio Co Ltd
• ClinicalTrials.gov Identifier: NCT01047475
• Other Study ID Numbers: MB104CLCT01
• First Posted: January 13, 2010
• Results First Posted: May 13, 2015
• Last Update Posted: May 13, 2015
• Last Verified: April 2015

Keywords provided by Microbio Co Ltd:

MB-6; FOLFOX4; Metastatic Colorectal Cancer

Additional relevant MeSH terms:

Colorectal Neoplasms; Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases