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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01047475
Recruitment Status : Completed
First Posted : January 13, 2010
Results First Posted : May 13, 2015
Last Update Posted : May 13, 2015
Information provided by (Responsible Party):
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.

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

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

Resource links provided by the National Library of Medicine

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

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.

Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years and older   (Adult, Older Adult)
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01047475

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

Responsible Party: Microbio Co Ltd Identifier: NCT01047475     History of Changes
Other Study ID Numbers: MB104CLCT01
First Posted: January 13, 2010    Key Record Dates
Results First Posted: May 13, 2015
Last Update Posted: May 13, 2015
Last Verified: April 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