NCT01335204|TerminatedPhase 1/2ResultsDMC
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lack of funding
Phase Ib/IIa Study of Cabazitaxel Plus Bavituximab for Patients With Castration-resistant Prostate Cancer Previously Treated With Chemotherapy
Sponsor study identifier
Secondary identifiers
OTHER · University of California, Irvine
OTHER · NCI Clinical Trials Reporting Program (CTRP)
interventional
4
1 country
1
Study Start
June 2011
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
March 2013
Actual (reported)Study Completion
March 2013
Actual (reported)This is a Phase Ib/IIa Study of Cabazitaxel plus Bavituximab in patients with castration-resistant prostate cancer (CRPC). The current study is designed to determine if the addition of bavituximab to cabazitaxel will improve progression free survival (PFS) or overall survival (OS). In addition, the Lead Researcher is requiring the collection of urine, and blood specimens for future research. This study will enroll patients with CRPC, who have been previously treated with docetaxel or a docetaxel-containing regimen. Patients may be intolerant of, or resistant to, docetaxel, or may have been previously treated with the agent without definite disease progression during therapy. Patients must meet the study eligibility criteria and must be competent to give informed consent.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
March 2013
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
April 11, 2011
Actual (reported)April 14, 2011
Actual (reported)June 2011
Date type not reportedThis date has not been verified as actual or estimated.
March 2013
Actual (reported)March 2013
Actual (reported)July 13, 2018
Actual (reported)Probability of Progression-free Survival at Day 85
The primary objective of this study is to determine the probability of progression-free survival (PFS) after 12 weeks of therapy in subjects with CRPC treated with cabazitaxel + bavituximab.
12 weeks
Measurement of PSA Response Rate
24 weeks
Objective Response Rate by RECIST for Patients With Measurable Disease
24 weeks
Overall Survival
24+ weeks
Number of With Grade 3 or 4 Toxicities
24 weeks
Progression-free Survival (PFS)
24+ weeks
Cabazitaxel (25 mg/m2) will be administered IV on Day 1 of each 21-day treatment cycle. Bavituximab (3 mg/kg) will be administered as an IV infusion on a weekly basis (Cycle 1 Day 2, all other cycles Day 1; day 8; day 15) for 8 cycles.
Cabazitaxel (25 mg/m2) will be administered IV on Day 1 of each 21-day treatment cycle, and bavituximab (3 mg/kg) will be administered as an IV infusion on a weekly basis (Cycle 1 Day 2, all other cycles Day 1; day 8; day 15) for 8 cycles.
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
These entries preserve how the registry describes the intervention. Their treatment roles are shown separately from molecular identities.
Grouped treatment entry
Cabazitaxel plus bavituximab
The registry names several treatments. This does not confirm that participants received them together or that they form a single product.
View registry recordMedical University of South Carolina
Charleston, South Carolina, 29425, United States
Michael Lilly, MD
Medical University of South Carolina
4 participants (actual enrollment reported by the registry).
First Submitted
April 11, 2011
First Posted
April 14, 2011
Study Start
June 2011
Date type not reportedThis date has not been verified as actual or estimated.
Contact the study team to confirm eligibility.
Primary Completion
March 2013
Actual (reported)Study Completion
March 2013
Actual (reported)Last Updated
July 13, 2018
Results First Posted
July 13, 2018
Record last verified: 2018-06
Download the complete ClinicalTrials.gov record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.
Source: ClinicalTrials.gov.
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