Trial Outcomes & Findings for A Phase II Trial of MB-6 Plus FOLFOX4 for Metastatic Colorectal Cancer (FDA IND 103675) (NCT NCT01047475)
NCT ID: NCT01047475
Last Updated: 2015-05-13
Results Overview
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.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
72 participants
Primary outcome timeframe
16 weeks
Results posted on
2015-05-13
Participant Flow
Participant milestones
| Measure |
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
|
Placebo+FOLFOX4
Placebo, 6 capsules tid be taken with meals plus FOLFOX4, will be given for 16 weeks
Placebo: 6# TID with meal
|
|---|---|---|
|
Overall Study
STARTED
|
34
|
38
|
|
Overall Study
COMPLETED
|
29
|
31
|
|
Overall Study
NOT COMPLETED
|
5
|
7
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
A Phase II Trial of MB-6 Plus FOLFOX4 for Metastatic Colorectal Cancer (FDA IND 103675)
Baseline characteristics by cohort
| Measure |
MB-6+FOLFOX4
n=34 Participants
MB-6 6 capsules tid be taken with meals plus FOLFOX4, will be given for 16 weeks
MB-6: 6# TID with meal
|
Placebo+FOLFOX4
n=38 Participants
Placebo, 6 capsules tid be taken with meals plus FOLFOX4, will be given for 16 weeks
Placebo: 6# TID with meal
|
Total
n=72 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
17 Participants
n=99 Participants
|
17 Participants
n=107 Participants
|
34 Participants
n=206 Participants
|
|
Age, Categorical
>=65 years
|
17 Participants
n=99 Participants
|
21 Participants
n=107 Participants
|
38 Participants
n=206 Participants
|
|
Age, Continuous
Age
|
62.2 years
STANDARD_DEVIATION 13.71 • n=99 Participants
|
63.0 years
STANDARD_DEVIATION 13.42 • n=107 Participants
|
62.6 years
STANDARD_DEVIATION 13.46 • n=206 Participants
|
|
Sex: Female, Male
Female
|
12 Participants
n=99 Participants
|
16 Participants
n=107 Participants
|
28 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
22 Participants
n=99 Participants
|
22 Participants
n=107 Participants
|
44 Participants
n=206 Participants
|
|
Region of Enrollment
Taiwan
|
34 participants
n=99 Participants
|
38 participants
n=107 Participants
|
72 participants
n=206 Participants
|
PRIMARY outcome
Timeframe: 16 weeksThe 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.
Outcome measures
| Measure |
MB-6+FOLFOX4
n=34 Participants
MB-6 6 capsules tid be taken with meals plus FOLFOX4, will be given for 16 weeks
MB-6: 6# TID with meal
|
Placebo+FOLFOX4
n=38 Participants
Placebo, 6 capsules tid be taken with meals plus FOLFOX4, will be given for 16 weeks
Placebo: 6# TID with meal
|
|---|---|---|
|
The Primary Efficacy Endpoint of This Study is the Best Overall Response (Complete Response + Partial Response)
|
61.76 percentage of Best overall Response
Interval 43.56 to 77.83
|
68.42 percentage of Best overall Response
Interval 51.35 to 82.5
|
Adverse Events
MB-6+FOLFOX4
Serious events: 6 serious events
Other events: 34 other events
Deaths: 0 deaths
Placebo+FOLFOX4
Serious events: 13 serious events
Other events: 38 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
MB-6+FOLFOX4
n=34 participants at risk
MB-6 6 capsules tid be taken with meals plus FOLFOX4, will be given for 16 weeks
MB-6: 6# TID with meal
|
Placebo+FOLFOX4
n=38 participants at risk
Placebo, 6 capsules tid be taken with meals plus FOLFOX4, will be given for 16 weeks
Placebo: 6# TID with meal
|
|---|---|---|
|
Investigations
Neutropenia
|
2.9%
1/34 • 16 weeks
|
10.5%
4/38 • 16 weeks
|
|
General disorders
Pyrexia
|
2.9%
1/34 • 16 weeks
|
2.6%
1/38 • 16 weeks
|
|
Gastrointestinal disorders
Ascites
|
2.9%
1/34 • 16 weeks
|
0.00%
0/38 • 16 weeks
|
|
Gastrointestinal disorders
Small intestinal haemorrhage
|
2.9%
1/34 • 16 weeks
|
0.00%
0/38 • 16 weeks
|
|
Surgical and medical procedures
Device occlusion
|
2.9%
1/34 • 16 weeks
|
0.00%
0/38 • 16 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Upper respiratory tract infection
|
2.9%
1/34 • 16 weeks
|
0.00%
0/38 • 16 weeks
|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.00%
0/34 • 16 weeks
|
2.6%
1/38 • 16 weeks
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/34 • 16 weeks
|
2.6%
1/38 • 16 weeks
|
|
Gastrointestinal disorders
Eteritis
|
0.00%
0/34 • 16 weeks
|
2.6%
1/38 • 16 weeks
|
|
Gastrointestinal disorders
Gastrointestinal haemorrhage
|
0.00%
0/34 • 16 weeks
|
2.6%
1/38 • 16 weeks
|
|
General disorders
Haematochezia
|
0.00%
0/34 • 16 weeks
|
2.6%
1/38 • 16 weeks
|
|
Gastrointestinal disorders
Ileus
|
0.00%
0/34 • 16 weeks
|
2.6%
1/38 • 16 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonia
|
0.00%
0/34 • 16 weeks
|
2.6%
1/38 • 16 weeks
|
|
Infections and infestations
Staphylococcal infection
|
0.00%
0/34 • 16 weeks
|
2.6%
1/38 • 16 weeks
|
|
Blood and lymphatic system disorders
Blood potassium decreased
|
0.00%
0/34 • 16 weeks
|
2.6%
1/38 • 16 weeks
|
|
Investigations
Neutrophil count decreased
|
0.00%
0/34 • 16 weeks
|
2.6%
1/38 • 16 weeks
|
|
Blood and lymphatic system disorders
Platelet count decreased
|
0.00%
0/34 • 16 weeks
|
2.6%
1/38 • 16 weeks
|
|
General disorders
Decreased appetite
|
0.00%
0/34 • 16 weeks
|
2.6%
1/38 • 16 weeks
|
|
Nervous system disorders
Cerebral haematoma
|
0.00%
0/34 • 16 weeks
|
2.6%
1/38 • 16 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonia aspiration
|
0.00%
0/34 • 16 weeks
|
2.6%
1/38 • 16 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
0.00%
0/34 • 16 weeks
|
2.6%
1/38 • 16 weeks
|
Other adverse events
| Measure |
MB-6+FOLFOX4
n=34 participants at risk
MB-6 6 capsules tid be taken with meals plus FOLFOX4, will be given for 16 weeks
MB-6: 6# TID with meal
|
Placebo+FOLFOX4
n=38 participants at risk
Placebo, 6 capsules tid be taken with meals plus FOLFOX4, will be given for 16 weeks
Placebo: 6# TID with meal
|
|---|---|---|
|
Investigations
Neutropenia
|
52.9%
18/34 • 16 weeks
|
60.5%
23/38 • 16 weeks
|
|
Blood and lymphatic system disorders
Platelet count decreased
|
61.8%
21/34 • 16 weeks
|
52.6%
20/38 • 16 weeks
|
|
Blood and lymphatic system disorders
Anaemia
|
35.3%
12/34 • 16 weeks
|
52.6%
20/38 • 16 weeks
|
|
Gastrointestinal disorders
Diarrhoea
|
41.2%
14/34 • 16 weeks
|
47.4%
18/38 • 16 weeks
|
|
General disorders
Decreased appetite
|
41.2%
14/34 • 16 weeks
|
39.5%
15/38 • 16 weeks
|
|
Hepatobiliary disorders
Aspartate aminotransferase increased
|
41.2%
14/34 • 16 weeks
|
36.8%
14/38 • 16 weeks
|
|
General disorders
Fatigue
|
38.2%
13/34 • 16 weeks
|
36.8%
14/38 • 16 weeks
|
|
General disorders
Mucosal inflammation
|
38.2%
13/34 • 16 weeks
|
31.6%
12/38 • 16 weeks
|
|
Gastrointestinal disorders
Nausea
|
38.2%
13/34 • 16 weeks
|
28.9%
11/38 • 16 weeks
|
|
General disorders
Vomiting
|
14.7%
5/34 • 16 weeks
|
28.9%
11/38 • 16 weeks
|
|
Hepatobiliary disorders
Alanine aminotransferase increased
|
26.5%
9/34 • 16 weeks
|
18.4%
7/38 • 16 weeks
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
23.5%
8/34 • 16 weeks
|
18.4%
7/38 • 16 weeks
|
|
Investigations
White blood cell count decreased
|
11.8%
4/34 • 16 weeks
|
21.1%
8/38 • 16 weeks
|
|
Investigations
Blood creatinine increased
|
5.9%
2/34 • 16 weeks
|
18.4%
7/38 • 16 weeks
|
|
General disorders
Pyrexia
|
11.8%
4/34 • 16 weeks
|
10.5%
4/38 • 16 weeks
|
|
Investigations
Neutrophil count decreased
|
8.8%
3/34 • 16 weeks
|
13.2%
5/38 • 16 weeks
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
14.7%
5/34 • 16 weeks
|
5.3%
2/38 • 16 weeks
|
|
Nervous system disorders
Neuropathy peripheral
|
5.9%
2/34 • 16 weeks
|
13.2%
5/38 • 16 weeks
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
5.9%
2/34 • 16 weeks
|
13.2%
5/38 • 16 weeks
|
|
Blood and lymphatic system disorders
Haemoglobin decreased
|
5.9%
2/34 • 16 weeks
|
10.5%
4/38 • 16 weeks
|
|
General disorders
Hiccups
|
8.8%
3/34 • 16 weeks
|
7.9%
3/38 • 16 weeks
|
|
Skin and subcutaneous tissue disorders
Palmar-plantar erythrodysaesthesia syndrome
|
8.8%
3/34 • 16 weeks
|
7.9%
3/38 • 16 weeks
|
|
Gastrointestinal disorders
Constipation
|
5.9%
2/34 • 16 weeks
|
7.9%
3/38 • 16 weeks
|
|
Gastrointestinal disorders
Dyspepsia
|
2.9%
1/34 • 16 weeks
|
10.5%
4/38 • 16 weeks
|
|
Skin and subcutaneous tissue disorders
Rash
|
14.7%
5/34 • 16 weeks
|
5.3%
2/38 • 16 weeks
|
|
Gastrointestinal disorders
Abdominal distension
|
5.9%
2/34 • 16 weeks
|
5.3%
2/38 • 16 weeks
|
|
General disorders
Oedema peripheral
|
5.9%
2/34 • 16 weeks
|
5.3%
2/38 • 16 weeks
|
|
General disorders
Weight decreased
|
2.9%
1/34 • 16 weeks
|
7.9%
3/38 • 16 weeks
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: OTHER