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

Colorectal Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01047475
• Other study ID #: MB104CLCT01
• Status: Completed
• Phase: Phase 2
• First received: December 22, 2009
• Last updated: April 28, 2015
• Start date: October 2009
• Est. completion date: December 2011

Study information

• Verified date: April 2015
• Source: Microbio Co Ltd
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 72
• Est. completion date: December 2011
• Est. primary completion date: April 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Colorectal Cancer
• Colorectal Neoplasms

Intervention

Drug:
• MB-6
6# TID with meal
• Placebo
6# TID with meal

Locations

Country	Name	City	State
Taiwan	Microbio Co., Ltd.	Taipei

Sponsors (1)

Lead Sponsor	Collaborator
Microbio Co Ltd

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Yes