A Phase I/II Clinical Trial Assessing Safety and Efficacy of BZL101 for Metastatic Breast Cancer

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Bionovo
ClinicalTrials.gov Identifier:
NCT00454532
First received: March 26, 2007
Last updated: February 27, 2012
Last verified: February 2012
Results First Received: February 27, 2012  
Study Type: Interventional
Study Design: Allocation: Non-Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Metastatic Breast Cancer
Intervention: Drug: BZL101

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups
  Description
Level 1 10g/day
Level 2 20g/day
Level 3 30g/day
Level 4 40g/day

Participant Flow:   Overall Study
    Level 1     Level 2     Level 3     Level 4  
STARTED     11     6     3     7  
COMPLETED     11     6     3     7  
NOT COMPLETED     0     0     0     0  



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
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Reporting Groups
  Description
Level 1 10g/day
Level 2 20g/day
Level 3 30g/day
Level 4 40g/day
Total Total of all reporting groups

Baseline Measures
    Level 1     Level 2     Level 3     Level 4     Total  
Number of Participants  
[units: participants]
  11     6     3     7     27  
Age  
[units: years]
Median ( Full Range )
  57  
  ( 32 to 78 )  
  67  
  ( 42 to 78 )  
  55  
  ( 54 to 67 )  
  61  
  ( 35 to 66 )  
  59  
  ( 32 to 78 )  
Gender  
[units: participants]
         
Female     11     6     3     7     27  
Male     0     0     0     0     0  
Ethnicity (NIH/OMB)  
[units: participants]
         
Hispanic or Latino     2     2     0     1     5  
Not Hispanic or Latino     9     4     3     6     22  
Unknown or Not Reported     0     0     0     0     0  
Race (NIH/OMB)  
[units: participants]
         
American Indian or Alaska Native     0     0     0     0     0  
Asian     0     0     0     0     0  
Native Hawaiian or Other Pacific Islander     0     0     0     0     0  
Black or African American     3     1     1     1     6  
White     8     5     2     6     21  
More than one race     0     0     0     0     0  
Unknown or Not Reported     0     0     0     0     0  
Region of Enrollment  
[units: participants]
         
United States     11     6     3     7     27  



  Outcome Measures
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1.  Primary:   Toxicity Based Upon Adverse Events Classifed by the NCI Common Terminology Criteria Version 3 (Phase 1)   [ Time Frame: Monthly ]

2.  Primary:   Response Evaluation Criteria In Solid Tumors (RECIST) (Phase 2)   [ Time Frame: 2 Months ]

3.  Primary:   Response Evaluation Criteria In Solid Tumors (RECIST) (Phase 2)   [ Time Frame: 2 months ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Mary Tagliaferri, MD
Organization: Bionovo
phone: 5106012000
e-mail: clinicaltrials@bionovo.com


Publications of Results:

Responsible Party: Bionovo
ClinicalTrials.gov Identifier: NCT00454532     History of Changes
Other Study ID Numbers: BZL-101-002
Study First Received: March 26, 2007
Results First Received: February 27, 2012
Last Updated: February 27, 2012
Health Authority: United States: Food and Drug Administration