Trial Outcomes & Findings for Ph Ib/IIa Study of Cabazitaxel Plus Bavituximab in Castration-resistant Prostate Cancer (NCT NCT01335204)

Last Updated: 2018-07-13

Results Overview

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.

Recruitment status

TERMINATED

Study phase

PHASE1/PHASE2

Target enrollment

4 participants

Primary outcome timeframe

12 weeks

Results posted on

2018-07-13

Participant Flow

Participant milestones

Participant milestones
Measure	Cabazitaxel Plus Bavituximab 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 Study STARTED	4
Overall Study COMPLETED	4
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Cabazitaxel Plus Bavituximab n=4 Participants 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.
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	2 Participants n=5 Participants
Age, Categorical >=65 years	2 Participants n=5 Participants
Sex: Female, Male Female	0 Participants n=5 Participants
Sex: Female, Male Male	4 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants
Race (NIH/OMB) White	4 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants

PRIMARY outcome

Timeframe: 12 weeks

Population: This study terminated early, so outcomes were not analyzed.

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.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 24 weeks

Population: This study terminated early, so outcomes were not analyzed.

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.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 24 weeks

Population: This study terminated early, so outcomes were not analyzed.

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

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 24+ weeks

Population: This study terminated early, so outcomes were not analyzed.

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.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 24 weeks

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.

Outcome measures

Outcome measures
Measure	Cabazitaxel Plus Bavituximab n=4 Participants 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.
Number of With Grade 3 or 4 Toxicities	5 grade 3 or 4 toxicities

SECONDARY outcome

Timeframe: 24+ weeks

Population: This study terminated early, so outcomes were not analyzed.

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.

Outcome measures

Outcome data not reported

Adverse Events

Cabazitaxel Plus Bavituximab

Serious events: 0 serious events

Other events: 4 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Cabazitaxel Plus Bavituximab n=4 participants at risk 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.
Blood and lymphatic system disorders anemia	25.0% 1/4 • Number of events 1
Blood and lymphatic system disorders febrile neutropenia	25.0% 1/4 • Number of events 1
General disorders fatigue	50.0% 2/4 • Number of events 2
Investigations neutrophil count decrease	50.0% 2/4 • Number of events 2
Musculoskeletal and connective tissue disorders chest wall pain	25.0% 1/4 • Number of events 1
Musculoskeletal and connective tissue disorders myalgia	25.0% 1/4 • Number of events 1
Nervous system disorders headache	25.0% 1/4 • Number of events 1
Nervous system disorders memory impairment	25.0% 1/4 • Number of events 1
Nervous system disorders peripheral sensory neuropathy	25.0% 1/4 • Number of events 1
Gastrointestinal disorders diarrhea	25.0% 1/4 • Number of events 1
Gastrointestinal disorders oral pain	25.0% 1/4 • Number of events 1
Gastrointestinal disorders stomach pain	25.0% 1/4 • Number of events 1
Gastrointestinal disorders vomiting	25.0% 1/4 • Number of events 1
Metabolism and nutrition disorders anorexia	25.0% 1/4 • Number of events 1
Renal and urinary disorders hematuria	25.0% 1/4 • Number of events 1
Renal and urinary disorders urinary urgency	25.0% 1/4 • Number of events 1
Skin and subcutaneous tissue disorders alopecia	25.0% 1/4 • Number of events 1
Vascular disorders hypertension	25.0% 1/4 • Number of events 1

Additional Information

Kate Anderton

Medical University of South Carolina

Phone: 843-792-2708

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place