Trial Outcomes & Findings for Study of Abiraterone Acetate and Prednisone in Combination With Cabazitaxel in Patients With Prostate Cancer (NCT NCT01845792)

NCT ID: NCT01845792

Last Updated: 2018-06-04

Results Overview

Progression-free survival at 3 months.

• Recruitment status: TERMINATED
• Study phase: PHASE2
• Target enrollment: 7 participants
• Primary outcome timeframe: 3 months
• Results posted on: 2018-06-04

Participant Flow

Participant milestones

Measure	Cabazitaxel With Abiraterone Acetate Cabazitaxel administered as a single intravenous dose every 3 weeks, in combination with abiraterone acetate and prednisone taken daily. Cabazitaxel with Abiraterone Acetate: Cabazitaxel intravenously every 3 weeks, in combination with abiraterone acetate and prednisone orally daily.	Cabazitaxel Alone Cabazitaxel administered as a single intravenous dose every 3 weeks Cabazitaxel: Cabazitaxel intravenously every 3 weeks
Overall Study STARTED	5	2
Overall Study COMPLETED	5	2
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Study of Abiraterone Acetate and Prednisone in Combination With Cabazitaxel in Patients With Prostate Cancer

Baseline characteristics by cohort

Measure	Cabazitaxel With Abiraterone Acetate n=5 Participants Cabazitaxel administered as a single intravenous dose every 3 weeks, in combination with abiraterone acetate and prednisone taken daily. Cabazitaxel with Abiraterone Acetate: Cabazitaxel intravenously every 3 weeks, in combination with abiraterone acetate and prednisone orally daily.	Cabazitaxel Alone n=2 Participants Cabazitaxel administered as a single intravenous dose every 3 weeks Cabazitaxel: Cabazitaxel intravenously every 3 weeks	Total n=7 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	1 Participants n=5 Participants	1 Participants n=7 Participants	2 Participants n=5 Participants
Age, Categorical >=65 years	4 Participants n=5 Participants	1 Participants n=7 Participants	5 Participants n=5 Participants
Sex: Female, Male Female	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Sex: Female, Male Male	5 Participants n=5 Participants	2 Participants n=7 Participants	7 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	2 Participants n=5 Participants	0 Participants n=7 Participants	2 Participants n=5 Participants
Race (NIH/OMB) White	3 Participants n=5 Participants	2 Participants n=7 Participants	5 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Region of Enrollment United States	5 participants n=5 Participants	2 participants n=7 Participants	7 participants n=5 Participants
Prior Docetaxel AND Abiraterone	5 Participants n=5 Participants	2 Participants n=7 Participants	7 Participants n=5 Participants

PRIMARY outcome

Timeframe: 3 months

Population: Due to early closure of the study and the low number of patients enrolled, no statistics or firm conclusions can be made.

Progression-free survival at 3 months.

Outcome measures

Measure	Cabazitaxel With Abiraterone Acetate n=5 Participants Cabazitaxel administered as a single intravenous dose every 3 weeks, in combination with abiraterone acetate and prednisone taken daily. Cabazitaxel with Abiraterone Acetate: Cabazitaxel intravenously every 3 weeks, in combination with abiraterone acetate and prednisone orally daily.	Cabazitaxel Alone n=2 Participants Cabazitaxel administered as a single intravenous dose every 3 weeks Cabazitaxel: Cabazitaxel intravenously every 3 weeks
Progression-Free Survival	5 Participants	2 Participants

SECONDARY outcome

Timeframe: 2 years

Prostate specific antigen (PSA) decline by 50% or more from baseline.

Outcome measures

Measure	Cabazitaxel With Abiraterone Acetate n=5 Participants Cabazitaxel administered as a single intravenous dose every 3 weeks, in combination with abiraterone acetate and prednisone taken daily. Cabazitaxel with Abiraterone Acetate: Cabazitaxel intravenously every 3 weeks, in combination with abiraterone acetate and prednisone orally daily.	Cabazitaxel Alone n=2 Participants Cabazitaxel administered as a single intravenous dose every 3 weeks Cabazitaxel: Cabazitaxel intravenously every 3 weeks
PSA Response	4 Participants	0 Participants

Adverse Events

Cabazitaxel With Abiraterone Acetate

Serious events: 1 serious events

Other events: 0 other events

Deaths: 5 deaths

Cabazitaxel Alone

Serious events: 0 serious events

Other events: 0 other events

Deaths: 2 deaths

Serious adverse events

Measure	Cabazitaxel With Abiraterone Acetate n=5 participants at risk Cabazitaxel administered as a single intravenous dose every 3 weeks, in combination with abiraterone acetate and prednisone taken daily. Cabazitaxel with Abiraterone Acetate: Cabazitaxel intravenously every 3 weeks, in combination with abiraterone acetate and prednisone orally daily.	Cabazitaxel Alone n=5 participants at risk；n=2 participants at risk Cabazitaxel administered as a single intravenous dose every 3 weeks Cabazitaxel: Cabazitaxel intravenously every 3 weeks
Blood and lymphatic system disorders Neutropenia	20.0% 1/5 • Number of events 1 • Patients were on study between 3 to 14 months. Adverse event data were collected throughout study. Due to early closure and small number of patients enrolled, no statistics or firm conclusions can be made. The 5 patients treated in the combination arm were treated with the standard dosing of both abiraterone acetate and cabazitaxel.	0.00% 0/2 • Patients were on study between 3 to 14 months. Adverse event data were collected throughout study. Due to early closure and small number of patients enrolled, no statistics or firm conclusions can be made. The 5 patients treated in the combination arm were treated with the standard dosing of both abiraterone acetate and cabazitaxel.

Other adverse events

Adverse event data not reported

Additional Information

Elaine Lam, MD

University of Colorado Cancer Center

Phone: 7208480273

Email: elaine.lam@ucdenver.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place