A Phase II Trial of MB-6 Plus FOLFOX4 for Metastatic Colorectal Cancer (FDA IND 103675)
Primary Purpose
Colorectal Cancer
Status
Completed
Phase
Phase 2
Locations
Taiwan
Study Type
Interventional
Intervention
MB-6
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Colorectal Cancer focused on measuring MB-6, FOLFOX4, Metastatic Colorectal Cancer
Eligibility Criteria
Inclusion Criteria:
- Patient with histologically confirmed colorectal cancer and/or clinical evidence of metastasis;
- At least one measurable lesion either by computer tomography (CT) scan or magnetic resonance imaging (MRI);
- Aged 20 years old or above;
- Eastern Cooperative Oncology Group (ECOG) performance status < 2;
- Adequate bone marrow reserve (hemoglobin > 9 g/dl, absolute neutrophil count > 1.5 x 109/L, platelets > 100 x 109/L);
- 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;
- Patients willing to participate in the trial and giving written informed consent.
Exclusion Criteria:
- Pregnant or lactating patients;
- Patients (male or female) with reproductive potential not using adequate contraceptive measures;
- Patients with evidence of central nervous system metastasis;
- Subject with active infection which requires systemic treatment of antibiotic, antifungal, or antiviral agents
- Current history of chronic diarrhea;
- Other serious illness or medical conditions (e.g.: history of angina, myocardial infarction);
- History of second primary malignancies except for adequately treated basal cell carcinoma of the skin or carcinoma in situ of the cervix;
- Concurrent treatment with any other anticancer therapy;
- 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;
- Patients treated with another investigational drug within 4 weeks of entry into this study.
Sites / Locations
- Microbio Co., Ltd.
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Placebo Comparator
Arm Label
MB-6+FOLFOX4
Placebo+FOLFOX4
Arm Description
MB-6 6 capsules tid be taken with meals plus FOLFOX4, will be given for 16 weeks
Placebo, 6 capsules tid be taken with meals plus FOLFOX4, will be given for 16 weeks
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01047475
Brief Title
A Phase II Trial of MB-6 Plus FOLFOX4 for Metastatic Colorectal Cancer (FDA IND 103675)
Official Title
A Phase II Trial of MB-6 Plus FOLFOX4 for Metastatic Colorectal Cancer
Study Type
Interventional
2. Study Status
Record Verification Date
April 2015
Overall Recruitment Status
Completed
Study Start Date
October 2009 (undefined)
Primary Completion Date
April 2011 (Actual)
Study Completion Date
December 2011 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Microbio Co Ltd
4. Oversight
Data Monitoring Committee
Yes
5. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Colorectal Cancer
Keywords
MB-6, FOLFOX4, Metastatic Colorectal Cancer
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
72 (Actual)
8. Arms, Groups, and Interventions
Arm Title
MB-6+FOLFOX4
Arm Type
Active Comparator
Arm Description
MB-6 6 capsules tid be taken with meals plus FOLFOX4, will be given for 16 weeks
Arm Title
Placebo+FOLFOX4
Arm Type
Placebo Comparator
Arm Description
Placebo, 6 capsules tid be taken with meals plus FOLFOX4, will be given for 16 weeks
Intervention Type
Drug
Intervention Name(s)
MB-6
Intervention Description
6# TID with meal
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
6# TID with meal
Primary Outcome Measure Information:
Title
The Primary Efficacy Endpoint of This Study is the Best Overall Response (Complete Response + Partial Response)
Description
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.
Time Frame
16 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Patient with histologically confirmed colorectal cancer and/or clinical evidence of metastasis;
At least one measurable lesion either by computer tomography (CT) scan or magnetic resonance imaging (MRI);
Aged 20 years old or above;
Eastern Cooperative Oncology Group (ECOG) performance status < 2;
Adequate bone marrow reserve (hemoglobin > 9 g/dl, absolute neutrophil count > 1.5 x 109/L, platelets > 100 x 109/L);
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;
Patients willing to participate in the trial and giving written informed consent.
Exclusion Criteria:
Pregnant or lactating patients;
Patients (male or female) with reproductive potential not using adequate contraceptive measures;
Patients with evidence of central nervous system metastasis;
Subject with active infection which requires systemic treatment of antibiotic, antifungal, or antiviral agents
Current history of chronic diarrhea;
Other serious illness or medical conditions (e.g.: history of angina, myocardial infarction);
History of second primary malignancies except for adequately treated basal cell carcinoma of the skin or carcinoma in situ of the cervix;
Concurrent treatment with any other anticancer therapy;
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;
Patients treated with another investigational drug within 4 weeks of entry into this study.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
William Chen, B.S.
Organizational Affiliation
China Medical University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Microbio Co., Ltd.
City
Taipei
Country
Taiwan
12. IPD Sharing Statement
Learn more about this trial
A Phase II Trial of MB-6 Plus FOLFOX4 for Metastatic Colorectal Cancer (FDA IND 103675)
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