Trial Outcomes & Findings for A Phase I/II Clinical Trial Assessing Safety and Efficacy of BZL101 for Metastatic Breast Cancer (NCT NCT00454532)
NCT ID: NCT00454532
Last Updated: 2012-03-16
Results Overview
Dose-Limiting Toxicities graded according to Common Terminology Criteria for Adverse Events, version 3.0
Recruitment status
COMPLETED
Study phase
PHASE1/PHASE2
Target enrollment
27 participants
Primary outcome timeframe
Monthly
Results posted on
2012-03-16
Participant Flow
Participant milestones
| Measure |
Level 1
10g/day
|
Level 2
20g/day
|
Level 3
30g/day
|
Level 4
40g/day
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
11
|
6
|
3
|
7
|
|
Overall Study
COMPLETED
|
11
|
6
|
3
|
7
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
A Phase I/II Clinical Trial Assessing Safety and Efficacy of BZL101 for Metastatic Breast Cancer
Baseline characteristics by cohort
| Measure |
Level 1
n=11 Participants
10g/day
|
Level 2
n=6 Participants
20g/day
|
Level 3
n=3 Participants
30g/day
|
Level 4
n=7 Participants
40g/day
|
Total
n=27 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age Continuous
|
57 years
n=93 Participants
|
67 years
n=4 Participants
|
55 years
n=27 Participants
|
61 years
n=483 Participants
|
59 years
n=36 Participants
|
|
Sex: Female, Male
Female
|
11 Participants
n=93 Participants
|
6 Participants
n=4 Participants
|
3 Participants
n=27 Participants
|
7 Participants
n=483 Participants
|
27 Participants
n=36 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
0 Participants
n=36 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
2 Participants
n=93 Participants
|
2 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
1 Participants
n=483 Participants
|
5 Participants
n=36 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
9 Participants
n=93 Participants
|
4 Participants
n=4 Participants
|
3 Participants
n=27 Participants
|
6 Participants
n=483 Participants
|
22 Participants
n=36 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
0 Participants
n=36 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
0 Participants
n=36 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
0 Participants
n=36 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
0 Participants
n=36 Participants
|
|
Race (NIH/OMB)
Black or African American
|
3 Participants
n=93 Participants
|
1 Participants
n=4 Participants
|
1 Participants
n=27 Participants
|
1 Participants
n=483 Participants
|
6 Participants
n=36 Participants
|
|
Race (NIH/OMB)
White
|
8 Participants
n=93 Participants
|
5 Participants
n=4 Participants
|
2 Participants
n=27 Participants
|
6 Participants
n=483 Participants
|
21 Participants
n=36 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
0 Participants
n=36 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
0 Participants
n=36 Participants
|
|
Region of Enrollment
United States
|
11 participants
n=93 Participants
|
6 participants
n=4 Participants
|
3 participants
n=27 Participants
|
7 participants
n=483 Participants
|
27 participants
n=36 Participants
|
PRIMARY outcome
Timeframe: MonthlyDose-Limiting Toxicities graded according to Common Terminology Criteria for Adverse Events, version 3.0
Outcome measures
| Measure |
Level 1
n=11 Participants
10g/day
|
Level 2
n=6 Participants
20g/day
|
Level 3
n=3 Participants
30g/day
|
Level 4
n=7 Participants
40g/day
|
|---|---|---|---|---|
|
Toxicity Based Upon Adverse Events Classifed by the NCI Common Terminology Criteria Version 3 (Phase 1)
Elevated AST
|
1 participants
|
0 participants
|
0 participants
|
0 participants
|
|
Toxicity Based Upon Adverse Events Classifed by the NCI Common Terminology Criteria Version 3 (Phase 1)
Diarrhea
|
0 participants
|
1 participants
|
0 participants
|
0 participants
|
|
Toxicity Based Upon Adverse Events Classifed by the NCI Common Terminology Criteria Version 3 (Phase 1)
Fatigue
|
0 participants
|
1 participants
|
0 participants
|
0 participants
|
|
Toxicity Based Upon Adverse Events Classifed by the NCI Common Terminology Criteria Version 3 (Phase 1)
Pain-rib cage
|
0 participants
|
0 participants
|
0 participants
|
1 participants
|
PRIMARY outcome
Timeframe: 2 MonthsBest Overall Tumor Response - Investigator Assessment
Outcome measures
| Measure |
Level 1
n=11 Participants
10g/day
|
Level 2
n=6 Participants
20g/day
|
Level 3
n=3 Participants
30g/day
|
Level 4
n=7 Participants
40g/day
|
|---|---|---|---|---|
|
Response Evaluation Criteria In Solid Tumors (RECIST) (Phase 2)
Complete Response and Partial Response
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
|
Response Evaluation Criteria In Solid Tumors (RECIST) (Phase 2)
Stable Disease
|
2 participants
|
3 participants
|
0 participants
|
0 participants
|
|
Response Evaluation Criteria In Solid Tumors (RECIST) (Phase 2)
Progressive Disease
|
7 participants
|
3 participants
|
3 participants
|
6 participants
|
|
Response Evaluation Criteria In Solid Tumors (RECIST) (Phase 2)
Unknown
|
2 participants
|
0 participants
|
0 participants
|
1 participants
|
PRIMARY outcome
Timeframe: 2 monthsBest Overall Tumor Response - Independent Radiology Assessment
Outcome measures
| Measure |
Level 1
n=11 Participants
10g/day
|
Level 2
n=6 Participants
20g/day
|
Level 3
n=3 Participants
30g/day
|
Level 4
n=7 Participants
40g/day
|
|---|---|---|---|---|
|
Response Evaluation Criteria In Solid Tumors (RECIST) (Phase 2)
Complete Response and Partial Response
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
|
Response Evaluation Criteria In Solid Tumors (RECIST) (Phase 2)
Stable Disease
|
3 participants
|
2 participants
|
0 participants
|
1 participants
|
|
Response Evaluation Criteria In Solid Tumors (RECIST) (Phase 2)
Progressive Disease
|
0 participants
|
3 participants
|
2 participants
|
3 participants
|
|
Response Evaluation Criteria In Solid Tumors (RECIST) (Phase 2)
Unknown
|
8 participants
|
1 participants
|
1 participants
|
3 participants
|
Adverse Events
Level 1
Serious events: 5 serious events
Other events: 11 other events
Deaths: 0 deaths
Level 2
Serious events: 0 serious events
Other events: 6 other events
Deaths: 0 deaths
Level 3
Serious events: 1 serious events
Other events: 3 other events
Deaths: 0 deaths
Level 4
Serious events: 4 serious events
Other events: 7 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Level 1
n=11 participants at risk
10g/day
|
Level 2
n=6 participants at risk
20g/day
|
Level 3
n=3 participants at risk
30g/day
|
Level 4
n=7 participants at risk
40g/day
|
|---|---|---|---|---|
|
Renal and urinary disorders
Obstruction-gu ureter
|
9.1%
1/11 • Number of events 1
|
0.00%
0/6
|
0.00%
0/3
|
0.00%
0/7
|
|
Renal and urinary disorders
Hemorrhage gu-bladder
|
9.1%
1/11 • Number of events 1
|
0.00%
0/6
|
0.00%
0/3
|
0.00%
0/7
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
18.2%
2/11 • Number of events 2
|
0.00%
0/6
|
0.00%
0/3
|
0.00%
0/7
|
|
Gastrointestinal disorders
Hemorrhage, GI-abdomen NOS
|
9.1%
1/11 • Number of events 1
|
0.00%
0/6
|
0.00%
0/3
|
0.00%
0/7
|
|
Reproductive system and breast disorders
Pain-breast
|
9.1%
1/11 • Number of events 1
|
0.00%
0/6
|
0.00%
0/3
|
0.00%
0/7
|
|
Hepatobiliary disorders
Pain-liver
|
9.1%
1/11 • Number of events 1
|
0.00%
0/6
|
0.00%
0/3
|
0.00%
0/7
|
|
Investigations
Hemoglobin
|
0.00%
0/11
|
0.00%
0/6
|
33.3%
1/3 • Number of events 1
|
0.00%
0/7
|
|
Metabolism and nutrition disorders
Hypoglycemia
|
0.00%
0/11
|
0.00%
0/6
|
0.00%
0/3
|
14.3%
1/7 • Number of events 1
|
|
Vascular disorders
Thrombosis left iliac vein
|
0.00%
0/11
|
0.00%
0/6
|
0.00%
0/3
|
14.3%
1/7 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Pain-rib cage due to vomiting
|
0.00%
0/11
|
0.00%
0/6
|
0.00%
0/3
|
14.3%
1/7 • Number of events 1
|
|
Infections and infestations
Infection-ulcer
|
0.00%
0/11
|
0.00%
0/6
|
0.00%
0/3
|
14.3%
1/7 • Number of events 1
|
Other adverse events
| Measure |
Level 1
n=11 participants at risk
10g/day
|
Level 2
n=6 participants at risk
20g/day
|
Level 3
n=3 participants at risk
30g/day
|
Level 4
n=7 participants at risk
40g/day
|
|---|---|---|---|---|
|
Gastrointestinal disorders
Nausea
|
36.4%
4/11 • Number of events 4
|
50.0%
3/6 • Number of events 4
|
66.7%
2/3 • Number of events 2
|
71.4%
5/7 • Number of events 5
|
|
Gastrointestinal disorders
Diarrhea
|
45.5%
5/11 • Number of events 6
|
50.0%
3/6 • Number of events 4
|
66.7%
2/3 • Number of events 2
|
71.4%
5/7 • Number of events 5
|
|
Gastrointestinal disorders
Vomiting
|
9.1%
1/11 • Number of events 1
|
33.3%
2/6 • Number of events 3
|
66.7%
2/3 • Number of events 3
|
57.1%
4/7 • Number of events 4
|
|
General disorders
Fatigue
|
9.1%
1/11 • Number of events 1
|
50.0%
3/6 • Number of events 3
|
33.3%
1/3 • Number of events 1
|
42.9%
3/7 • Number of events 3
|
|
Nervous system disorders
Pain-headache
|
27.3%
3/11 • Number of events 3
|
33.3%
2/6 • Number of events 3
|
66.7%
2/3 • Number of events 2
|
14.3%
1/7 • Number of events 1
|
|
Metabolism and nutrition disorders
Anorexia
|
27.3%
3/11 • Number of events 3
|
0.00%
0/6
|
0.00%
0/3
|
14.3%
1/7 • Number of events 1
|
|
Gastrointestinal disorders
Distension/bloating
|
9.1%
1/11 • Number of events 1
|
33.3%
2/6 • Number of events 2
|
0.00%
0/3
|
0.00%
0/7
|
|
Gastrointestinal disorders
Flatulence
|
9.1%
1/11 • Number of events 1
|
16.7%
1/6 • Number of events 1
|
0.00%
0/3
|
14.3%
1/7 • Number of events 1
|
|
Gastrointestinal disorders
Pain-abdomen NOS
|
18.2%
2/11 • Number of events 2
|
16.7%
1/6 • Number of events 1
|
0.00%
0/3
|
14.3%
1/7 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Sweating
|
18.2%
2/11 • Number of events 2
|
16.7%
1/6 • Number of events 1
|
0.00%
0/3
|
14.3%
1/7 • Number of events 1
|
|
Metabolism and nutrition disorders
Dehydration
|
9.1%
1/11 • Number of events 1
|
16.7%
1/6 • Number of events 1
|
0.00%
0/3
|
0.00%
0/7
|
|
Investigations
ALT elevation
|
27.3%
3/11 • Number of events 3
|
33.3%
2/6 • Number of events 2
|
33.3%
1/3 • Number of events 1
|
0.00%
0/7
|
|
Investigations
AST elevation
|
27.3%
3/11 • Number of events 3
|
33.3%
2/6 • Number of events 2
|
0.00%
0/3
|
0.00%
0/7
|
|
Investigations
Decreased hemoglobin
|
27.3%
3/11 • Number of events 3
|
0.00%
0/6
|
33.3%
1/3 • Number of events 1
|
28.6%
2/7 • Number of events 2
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place