Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

Ph Ib/IIa Study of Cabazitaxel Plus Bavituximab in Castration-resistant Prostate Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01335204
Recruitment Status : Terminated (lack of funding)
First Posted : April 14, 2011
Results First Posted : July 13, 2018
Last Update Posted : July 13, 2018
Sponsor:
Collaborator:
Peregrine Pharmaceuticals
Information provided by (Responsible Party):
Medical University of South Carolina

Study Type Interventional
Study Design Allocation: N/A;   Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions Prostate Cancer
Prostatic Neoplasms
Intervention Drug: Cabazitaxel plus bavituximab
Enrollment 4
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Cabazitaxel Plus Bavituximab
Hide Arm/Group Description

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 plus bavituximab: 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.

Period Title: Overall Study
Started 4
Completed 4
Not Completed 0
Arm/Group Title Cabazitaxel Plus Bavituximab
Hide Arm/Group Description

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 plus bavituximab: 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.

Overall Number of Baseline Participants 4
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 4 participants
<=18 years
0
   0.0%
Between 18 and 65 years
2
  50.0%
>=65 years
2
  50.0%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 4 participants
Female
0
   0.0%
Male
4
 100.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 4 participants
American Indian or Alaska Native
0
   0.0%
Asian
0
   0.0%
Native Hawaiian or Other Pacific Islander
0
   0.0%
Black or African American
0
   0.0%
White
4
 100.0%
More than one race
0
   0.0%
Unknown or Not Reported
0
   0.0%
1.Primary Outcome
Title Probability of Progression-free Survival at Day 85
Hide Description 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.
Time Frame 12 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
This study terminated early, so outcomes were not analyzed.
Arm/Group Title Cabazitaxel Plus Bavituximab
Hide Arm/Group Description:

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 plus bavituximab: 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.

Overall Number of Participants Analyzed 0
No data displayed because Outcome Measure has zero total analyzed.
2.Secondary Outcome
Title Measurement of PSA Response Rate
Hide Description To estimate the PSA response rate from cabazitaxel + bavituximab therapy in CRPC patients previously treated with docetaxel. PSA response rate will be assessed at multiple time points during the 24 wks of study treatment.
Time Frame 24 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
This study terminated early, so outcomes were not analyzed.
Arm/Group Title Cabazitaxel Plus Bavituximab
Hide Arm/Group Description:

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 plus bavituximab: 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.

Overall Number of Participants Analyzed 0
No data displayed because Outcome Measure has zero total analyzed.
3.Secondary Outcome
Title Objective Response Rate by RECIST for Patients With Measurable Disease
Hide Description To estimate the objective response rate from cabazitaxel + bavituximab therapy in CRPC patients previously treated with docetaxel. Objective response rate will be assessed at day 85, 169
Time Frame 24 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
This study terminated early, so outcomes were not analyzed.
Arm/Group Title Cabazitaxel Plus Bavituximab
Hide Arm/Group Description:

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 plus bavituximab: 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.

Overall Number of Participants Analyzed 0
No data displayed because Outcome Measure has zero total analyzed.
4.Secondary Outcome
Title Overall Survival
Hide Description To estimate the overall survival in subjects with CRPC (previously treated with docetaxel) following cabazitaxel + bavituximab therapy. Overall survival will be assessed continually during the duration of the study.
Time Frame 24+ weeks
Hide Outcome Measure Data
Hide Analysis Population Description
This study terminated early, so outcomes were not analyzed.
Arm/Group Title Cabazitaxel Plus Bavituximab
Hide Arm/Group Description:

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 plus bavituximab: 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.

Overall Number of Participants Analyzed 0
No data displayed because Outcome Measure has zero total analyzed.
5.Secondary Outcome
Title Number of With Grade 3 or 4 Toxicities
Hide Description To document the toxicity of cabazitaxel + bavituximab therapy in CRPC patients previously treated with docetaxel. Toxicity will be assessed continually during the 24 wks of study therapy.
Time Frame 24 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Cabazitaxel Plus Bavituximab
Hide Arm/Group Description:

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 plus bavituximab: 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.

Overall Number of Participants Analyzed 4
Measure Type: Number
Unit of Measure: grade 3 or 4 toxicities
5
6.Secondary Outcome
Title Progression-free Survival (PFS)
Hide Description Determination of progression-free survival in subjects treated with cabazitaxel + bavituximab for CRPC previously treated with docetaxel. PFS will be assessed continually during the entire study.
Time Frame 24+ weeks
Hide Outcome Measure Data
Hide Analysis Population Description
This study terminated early, so outcomes were not analyzed.
Arm/Group Title Cabazitaxel Plus Bavituximab
Hide Arm/Group Description:

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 plus bavituximab: 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.

Overall Number of Participants Analyzed 0
No data displayed because Outcome Measure has zero total analyzed.
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Cabazitaxel Plus Bavituximab
Hide Arm/Group Description

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 plus bavituximab: 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.

All-Cause Mortality
Cabazitaxel Plus Bavituximab
Affected / at Risk (%)
Total   0/4 (0.00%)    
Hide Serious Adverse Events
Cabazitaxel Plus Bavituximab
Affected / at Risk (%) # Events
Total   0/4 (0.00%)    
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Cabazitaxel Plus Bavituximab
Affected / at Risk (%) # Events
Total   4/4 (100.00%)    
Blood and lymphatic system disorders   
anemia   1/4 (25.00%)  1
febrile neutropenia   1/4 (25.00%)  1
Gastrointestinal disorders   
diarrhea   1/4 (25.00%)  1
oral pain   1/4 (25.00%)  1
stomach pain   1/4 (25.00%)  1
vomiting   1/4 (25.00%)  1
General disorders   
fatigue   2/4 (50.00%)  2
Investigations   
neutrophil count decrease   2/4 (50.00%)  2
Metabolism and nutrition disorders   
anorexia   1/4 (25.00%)  1
Musculoskeletal and connective tissue disorders   
chest wall pain   1/4 (25.00%)  1
myalgia   1/4 (25.00%)  1
Nervous system disorders   
headache   1/4 (25.00%)  1
memory impairment   1/4 (25.00%)  1
peripheral sensory neuropathy   1/4 (25.00%)  1
Renal and urinary disorders   
hematuria   1/4 (25.00%)  1
urinary urgency   1/4 (25.00%)  1
Skin and subcutaneous tissue disorders   
alopecia   1/4 (25.00%)  1
Vascular disorders   
hypertension   1/4 (25.00%)  1
Indicates events were collected by systematic assessment
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Kate Anderton
Organization: Medical University of South Carolina
Phone: 843-792-2708
EMail: anderton@musc.edu
Layout table for additonal information
Responsible Party: Medical University of South Carolina
ClinicalTrials.gov Identifier: NCT01335204    
Other Study ID Numbers: MUSC 101637
HS#2011-8083 ( Other Identifier: University of California, Irvine )
NCI-2011-01248 ( Other Identifier: NCI Clinical Trials Reporting Program (CTRP) )
First Submitted: April 11, 2011
First Posted: April 14, 2011
Results First Submitted: May 7, 2018
Results First Posted: July 13, 2018
Last Update Posted: July 13, 2018