Colorectal CancerPhase 2NCT01047475
A Phase II Trial of MB-6 Plus FOLFOX4 for Metastatic Colorectal Cancer (FDA IND 103675)
A Phase 2 study testing MB-6 in people with Colorectal Cancer, run by Microbio Co Ltd at 1 site in Taiwan.
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. Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Colorectal Cancer
- What is being tested?
- MB-6
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 72 participants
- Where
- 1 siteTaiwan
- Study dates
- Oct 2009to Dec 2011
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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);
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- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase II Trial of MB-6 Plus FOLFOX4 for Metastatic Colorectal Cancer
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.
- Conditions
- Colorectal Cancer
- Being tested
- MB-6, Placebo
- Keywords
- MB-6, FOLFOX4, Metastatic Colorectal Cancer
- Medical subject headings
- Colorectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MB-6Drug
6# TID with meal
PlaceboDrug
6# TID with meal
| Study group | Role | What they receive |
|---|---|---|
| MB-6+FOLFOX4 | Active comparator | MB-6 6 capsules tid be taken with meals plus FOLFOX4, will be given for 16 weeks Receives: Drug: MB-6 |
| Placebo+FOLFOX4 | Placebo comparator | Placebo, 6 capsules tid be taken with meals plus FOLFOX4, will be given for 16 weeks Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 16 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jan 2010 (estimated)
- Study startOct 2009
- Primary completionApr 2011
- Study completionDec 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Colorectal CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 72 participants (actual)
Sponsor and investigators
- Lead sponsor
- Microbio Co Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- William Chen, B.S., Principal investigator, China Medical University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01047475
- Sponsor's protocol ID
- MB104CLCT01
- Status last verified
- Apr 2015
- First submitted
- 22 Dec 2009
- Last updated
- 13 May 2015
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 13 May 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II Trial of MB-6 Plus FOLFOX4 for Metastatic Colorectal Cancer
- ClinicalTrials.gov ID
- NCT01047475
- Acronym / sponsor ID
- MB104CLCT01
- Conditions
- Colorectal Cancer
- Keywords
- MB-6, FOLFOX4, Metastatic Colorectal Cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 72 participants (actual)
- Lead sponsor
- Microbio Co LtdIndustry (pharma, biotech, devices)
- Study start
- Oct 2009
- Primary completion
- Apr 2011 (actual)
- Study completion
- Dec 2011 (actual)
- First posted
- 13 Jan 2010 (estimated)
- Results
- Posted 13 May 2015
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| MB-6+FOLFOX4 | Active comparator | Drug: MB-6MB-6 6 capsules tid be taken with meals plus FOLFOX4, will be given for 16 weeks |
| Placebo+FOLFOX4 | Placebo comparator | Drug: PlaceboPlacebo, 6 capsules tid be taken with meals plus FOLFOX4, will be given for 16 weeks |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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);
Key exclusion criteria (10 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MB-66# TID with meal | Drug | MB-6+FOLFOX4 |
| Placebo6# TID with meal | Drug | Placebo+FOLFOX4 |
Primary outcome
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.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 May 2015.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
William Chen, B.S. principal investigator
China Medical University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing MB-6 in people with Colorectal Cancer, run by Microbio Co Ltd at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 May 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 13 May 2015). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The Primary Efficacy Endpoint of This Study is the Best Overall Response (Complete Response + Partial Response) (time frame: 16 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 May 2015.