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

This study has been completed.
Information provided by (Responsible Party):
Microbio Co Ltd Identifier:
First received: December 22, 2009
Last updated: April 28, 2015
Last verified: April 2015
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 Intervention Phase
Colorectal Cancer Drug: MB-6 Drug: Placebo Phase 2

Study Type: Interventional
Study Design: 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

Resource links provided by NLM:

Further study details as provided by Microbio Co Ltd:

Primary Outcome Measures:
  • 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.

Enrollment: 72
Study Start Date: October 2009
Study Completion Date: December 2011
Primary Completion Date: April 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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


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

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
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Please refer to this study by its identifier: NCT01047475

Microbio Co., Ltd.
Taipei, Taiwan
Sponsors and Collaborators
Microbio Co Ltd
Principal Investigator: William Chen, B.S. China Medical University Hospital
  More Information

Responsible Party: Microbio Co Ltd Identifier: NCT01047475     History of Changes
Other Study ID Numbers: MB104CLCT01
Study First Received: December 22, 2009
Results First Received: April 28, 2015
Last Updated: April 28, 2015

Keywords provided by Microbio Co Ltd:
Metastatic Colorectal Cancer

Additional relevant MeSH terms:
Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases processed this record on September 20, 2017