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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT02135887
Other study ID # MB104CLCT02
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date November 4, 2013
Est. completion date December 31, 2022

Study information

Verified date December 2020
Source Microbio Co Ltd
Contact William Chen, M.D.
Phone 886-4-22052121
Email wtchen@mail.cmuh.org.tw
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

This is a randomized, double-blind, placebo-controlled multi-center phaseⅢstudy to evaluate efficacy and safety of oxaliplatin-based chemotherapy plus MB-6(320 mg/capsule, 6 capsules tid) in patients with stage 3 colorectal cancer who underwent surgical excision of their primary tumor.


Description:

The investigational new drug, MB-6, in the proposed clinical trial is to be used as an adjuvant therapy for metastatic colorectal cancer patients. All of six extracts have been used in human with a long history, and many literatures reported the medicinal use either individually or as ingredients of formulations. MB-6 may provide its therapeutic benefits via inhibition of tumor induction or enhancing the efficacy of chemotherapy in colorectal cancer.


Recruitment information / eligibility

Status Recruiting
Enrollment 184
Est. completion date December 31, 2022
Est. primary completion date March 31, 2022
Accepts healthy volunteers No
Gender All
Age group 20 Years to 80 Years
Eligibility Inclusion Criteria: 1. Men or women 20 years of age or older. 2. Histologically or cytologically confirmed stage 3 colorectal adenocarcinoma. 3. Complete resection of the primary tumor without gross or microscopic evidence of residual disease. 4. No more than 8 weeks have elapsed from the time of surgery and have recovered from the effects. 5. Eastern Cooperative Oncology Group Performance Status (ECOG PS) < 2 at the time of screening. 6. Hematological function: ANC=1500/mm3, Hemoglobin =9.0 g/dL, Platelet count =100000/mm3. 7. Kidney function:Serum creatinine <2 mg/dL. 8. Liver function: AST =3 times ULN, ALT =3 times ULN, Total Bilirubin =2 times ULN. 9. Ability to understand and the willingness to sign a written informed consent document according to institutional guidelines. 10. Men and women of childbearing potential must agree to employ adequate contraception during the study period. Exclusion Criteria: 1. History of second primary malignancies except for adequately treated basal cell carcinoma of the skin or carcinoma in situ of the cervix. 2. Systemic chemotherapy, immune therapy or experimental or approved antibodies/proteins (e.g. bevacizumab) administered after surgery and prior to randomization. 3. Concurrent treatment with any other anticancer therapy. 4. Radiotherapy =14 days prior to randomization. 5. Any unresolved toxicity > CTC (Common Toxicity Criteria) grade 1 from previous anti-cancer therapy (including radiotherapy) except haematological toxicity and alopecia. 6. Patients with congestive heart failure, epilepsy, or other significant medical conditions as judged by the investigator. 7. Contraindications to FOLFOX chemotherapy: peripheral neuropathy NCI CTC >1, liver failure, uncontrolled coronary heart disease, myocardial infarction within the previous 6 months before randomization. 8. Patient of child-bearing potential is evidently pregnant or is breast feeding.

Study Design


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 endpoint is the incidence of grade 4 neutropenia during the chemotherapy period, defined as an absolute neutrophil count (ANC) <500/mm3. The primary endpoint is the incidence of grade 4 neutropenia during the chemotherapy, defined as an absolute neutrophil count (ANC)<500/mm3 18 weeks
Secondary Time to first Grade 4 Neutropenia To determine the time interval from randomization to the first episode of grade 4 Neutropenia.
The analyses for incidence of study event will be conducted using logistic regression model method to adjust for gender and the regimen of chemotherapy (e.g., FOLFOX4 or FOLFOX6).
18 weeks
Secondary Incidence of Febrile Neutropenia The febrile neutropenia is defined as an ANC <1000/mm3 and a single temperature =38.3 degree of C or a sustained temperature of =38.0 degree C for more than one hour. 18 weeks
Secondary Incidence of Grade 3 or 4 Neutropenia The grade 3 or 4 neutropenia during the chemotherapy period is defined as an absolute neutrophil count (ANC) <1000/mm3. 18 weeks
Secondary Change in Serum Creatinine level Any change in Serum Creatinine level during the chemotherapy period 18 weeks
Secondary Health-Related Quality of Life (HRQoL) - QLQ-C30 Health-Related Quality of Life (HRQoL) - QLQ-C30 should be completed at baseline, day 71 and end of study. 18 weeks
Secondary Quality of Life -VAS on Fatigue, Constipation, Appetite Quality of Life -VAS on Fatigue, Constipation, Appetite will be assessed by patients every two weeks until end of study. 18 weeks
Secondary Compliance with Chemotherapy The compliance with chemotherapy will be summarized by descriptive statistic and listed by each cycle and overall period. 18 weeks
Secondary Increase in Body Weight Any increased body weight during the chemotherapy period. 18 weeks
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