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

NCT01047475 | Completed Phase 2 Results DMC

• 1 other identifier: MB104CLCT01
• Study Type: interventional
• Target: 72
• Locations: 1 country
• Sites: 1

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.

Conditions

Colorectal Cancer

Keywords

MB-6; FOLFOX4; Metastatic Colorectal Cancer

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

MB-6+FOLFOX4

ACTIVE COMPARATOR

MB-6 6 capsules tid be taken with meals plus FOLFOX4, will be given for 16 weeks

Drug: MB-6

Placebo+FOLFOX4

PLACEBO COMPARATOR

Placebo, 6 capsules tid be taken with meals plus FOLFOX4, will be given for 16 weeks

Drug: Placebo

Interventions

MB-6 DRUG

6# TID with meal

MB-6+FOLFOX4

Placebo DRUG

6# TID with meal

Placebo+FOLFOX4

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Microbio Co Ltd: lead

Study Sites (1)

Microbio Co., Ltd.

Taipei, Taiwan

Location

MeSH Terms

Conditions

Colorectal Neoplasms

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases

Results Point of Contact

• Title: Director of Clinical Trials
• Organization: Microbio / Sophie Chang

sophie_chang@fountainmab.com

886-2-2570-5596

Study Officials

• William Chen, B.S.

  China Medical University Hospital

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 22, 2009
• First Posted: January 13, 2010
• Study Start: October 1, 2009
• Primary Completion: April 1, 2011
• Study Completion: December 1, 2011
• Last Updated: May 13, 2015
• Results First Posted: May 13, 2015

Record last verified: 2015-04

Locations

TW (1)