Colorectal Cancer
Conditions
Keywords
MB-6, FOLFOX4, Metastatic Colorectal Cancer
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.
Interventions
DRUGMB-6
6# TID with meal
DRUGPlacebo
6# TID with meal
Sponsors
Microbio Co Ltd
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
20 Years to No maximum
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The Primary Efficacy Endpoint of This Study is the Best Overall Response (Complete Response + Partial Response) | 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. |
Countries
Taiwan
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| MB-6+FOLFOX4 MB-6 6 capsules tid be taken with meals plus FOLFOX4, will be given for 16 weeks
MB-6: 6# TID with meal | 34 |
| Placebo+FOLFOX4 Placebo, 6 capsules tid be taken with meals plus FOLFOX4, will be given for 16 weeks
Placebo: 6# TID with meal | 38 |
| Total | 72 |
Baseline characteristics
| Characteristic | Placebo+FOLFOX4 | MB-6+FOLFOX4 | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 21 Participants | 17 Participants | 38 Participants |
| Age, Categorical Between 18 and 65 years | 17 Participants | 17 Participants | 34 Participants |
| Age, Continuous Age | 63.0 years STANDARD_DEVIATION 13.42 | 62.2 years STANDARD_DEVIATION 13.71 | 62.6 years STANDARD_DEVIATION 13.46 |
| Region of Enrollment Taiwan | 38 participants | 34 participants | 72 participants |
| Sex: Female, Male Female | 16 Participants | 12 Participants | 28 Participants |
| Sex: Female, Male Male | 22 Participants | 22 Participants | 44 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 34 / 34 | 38 / 38 |
| serious Total, serious adverse events | 6 / 34 | 13 / 38 |
Outcome results
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.
Time frame: 16 weeks
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| MB-6+FOLFOX4 | The Primary Efficacy Endpoint of This Study is the Best Overall Response (Complete Response + Partial Response) | 61.76 percentage of Best overall Response |
| Placebo+FOLFOX4 | The Primary Efficacy Endpoint of This Study is the Best Overall Response (Complete Response + Partial Response) | 68.42 percentage of Best overall Response |