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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Microbio Co Ltd
ClinicalTrials.gov Identifier:
NCT01047475
First received: December 22, 2009
Last updated: May 6, 2014
Last verified: May 2014
  Purpose

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
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, 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 ] [ Designated as safety issue: Yes ]

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

  Eligibility

Ages Eligible for Study:   20 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01047475

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

No publications provided

Responsible Party: Microbio Co Ltd
ClinicalTrials.gov Identifier: NCT01047475     History of Changes
Other Study ID Numbers: MB104CLCT01
Study First Received: December 22, 2009
Last Updated: May 6, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by Microbio Co Ltd:
A Phase II Trial of MB-6 plus FOLFOX4 for 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

ClinicalTrials.gov processed this record on October 01, 2014