Trial Outcomes & Findings for Enzalutamide and Cabazitaxel in Treating Patients With Metastatic, Castration-Resistant Prostate Cancer (NCT NCT02522715)

NCT ID: NCT02522715

Last Updated: 2025-08-17

Results Overview

The percentage of participants will be reported with 95% confidence interval using exact method.

Recruitment status

ACTIVE_NOT_RECRUITING

Study phase

PHASE1/PHASE2

Target enrollment

37 participants

Primary outcome timeframe

Up to 42 days

Results posted on

2025-08-17

Participant Flow

Phase I accrual occurred between November 2015 and April 2016. Phase II accrual occurred between January 2017 and March 2019. The last follow-up date is anticipated to be December 2023.

One participant withdrew before receiving study treatment and was therefore excluded from safety and efficacy analysis.

Participant milestones

Participant milestones
Measure	Phase I - Treatment (Cabazitaxel, Enzalutamide) Patients receive 25 mg/m2 cabazitaxel IV over 1 hour on day 1 and enzalutamide PO QD on days 1-21 (days 2-21 of cycle 1). Patients also receive prednisone PO BID as standard of care with cabazitaxel. Cycles repeat every 21 days for 6-10 cycles in the absence of disease progression or unacceptable toxicity. Patients may continue enzalutamide PO QD on days 1-28 in the absence of disease progression or unacceptable toxicity. Cabazitaxel: Given IV Enzalutamide: Given PO Laboratory Biomarker Analysis: Correlative studies Pharmacological Study: Correlative studies Prednisone: Given PO	Phase II - Treatment (Cabazitaxel, Enzalutamide) Patients receive 25 mg/m2 cabazitaxel IV over 1 hour on day 1 and enzalutamide PO QD on days 1-21 (days 2-21 of cycle 1). Patients also receive prednisone PO BID as standard of care with cabazitaxel. Cycles repeat every 21 days for 6-10 cycles in the absence of disease progression or unacceptable toxicity. Patients may continue enzalutamide PO QD on days 1-28 in the absence of disease progression or unacceptable toxicity. Cabazitaxel: Given IV Enzalutamide: Given PO Laboratory Biomarker Analysis: Correlative studies Pharmacological Study: Correlative studies Prednisone: Given PO
Overall Study STARTED	3	33
Overall Study COMPLETED	3	33
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Enzalutamide and Cabazitaxel in Treating Patients With Metastatic, Castration-Resistant Prostate Cancer

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Phase I - Treatment (Cabazitaxel, Enzalutamide) n=3 Participants Patients receive 25 mg/m2 cabazitaxel IV over 1 hour on day 1 and enzalutamide PO QD on days 1-21 (days 2-21 of cycle 1). Patients also receive prednisone PO BID as standard of care with cabazitaxel. Cycles repeat every 21 days for 6-10 cycles in the absence of disease progression or unacceptable toxicity. Patients may continue enzalutamide PO QD on days 1-28 in the absence of disease progression or unacceptable toxicity. Cabazitaxel: Given IV Enzalutamide: Given PO Laboratory Biomarker Analysis: Correlative studies Pharmacological Study: Correlative studies Prednisone: Given PO	Phase II - Treatment (Cabazitaxel, Enzalutamide) n=33 Participants Patients receive 25 mg/m2 cabazitaxel IV over 1 hour on day 1 and enzalutamide PO QD on days 1-21 (days 2-21 of cycle 1). Patients also receive prednisone PO BID as standard of care with cabazitaxel. Cycles repeat every 21 days for 6-10 cycles in the absence of disease progression or unacceptable toxicity. Patients may continue enzalutamide PO QD on days 1-28 in the absence of disease progression or unacceptable toxicity.	Total n=36 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	7 Participants n=7 Participants	8 Participants n=5 Participants
Age, Categorical >=65 years	2 Participants n=5 Participants	26 Participants n=7 Participants	28 Participants n=5 Participants
Age, Continuous	66 years n=5 Participants	69 years n=7 Participants	69 years 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	3 Participants n=5 Participants	33 Participants n=7 Participants	36 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	1 Participants n=7 Participants	1 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) White	3 Participants n=5 Participants	28 Participants n=7 Participants	31 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	3 Participants n=7 Participants	3 Participants n=5 Participants
Region of Enrollment United States	3 participants n=5 Participants	33 participants n=7 Participants	36 participants n=5 Participants

PRIMARY outcome

Timeframe: Up to 42 days

Population: Patients with metastatic CRPC. Phase I patients who received at least two cycles of study drugs will be evaluable for DLT analysis.

The percentage of participants will be reported with 95% confidence interval using exact method.

Outcome measures

Outcome measures
Measure	Phase I - Treatment (Cabazitaxel, Enzalutamide) n=3 Participants Patients receive 25 mg/m2 cabazitaxel IV over 1 hour on day 1 and enzalutamide PO QD on days 1-21 (days 2-21 of cycle 1). Patients also receive prednisone PO BID as standard of care with cabazitaxel. Cycles repeat every 21 days for 6-10 cycles in the absence of disease progression or unacceptable toxicity. Patients may continue enzalutamide PO QD on days 1-28 in the absence of disease progression or unacceptable toxicity. Cabazitaxel: Given IV Enzalutamide: Given PO Laboratory Biomarker Analysis: Correlative studies Pharmacological Study: Correlative studies Prednisone: Given PO
Percentage of Participants With Dose Limiting ToxicitiesGgraded by National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0 (Phase I)	0.0 percentage of participants Interval 0.0 to 0.0

PRIMARY outcome

Timeframe: Baseline to time of >= 90% PSA decline, assessed up to 68 weeks

Population: Phase I and Phase II participants with mCRPC who received at least one cycle of study drugs. For efficacy outcomes, Phase I and II arms were combined as participants in each arm received identical treatments of 25 mg/m2 cabazitaxel q3 weeks plus enzalutamide 160 mg QD. Per protocol, dose limiting toxicities (DLTs) identified during Phase I informed the dose of cabazitaxel in Phase II. No DLTs were identified during Phase I, and the study proceeded to Phase II at the identical dose.

The percentage of participants with a \>= 90% PSA decline from baseline will be reported with 95% confidence interval using exact method. 'PSA response' is based on Prostate Cancer Working Group 2's (PCWG2) recommendations, which do not offer a specific definition as no single degree of decline has been established.

Outcome measures

Outcome measures
Measure	Phase I - Treatment (Cabazitaxel, Enzalutamide) n=36 Participants Patients receive 25 mg/m2 cabazitaxel IV over 1 hour on day 1 and enzalutamide PO QD on days 1-21 (days 2-21 of cycle 1). Patients also receive prednisone PO BID as standard of care with cabazitaxel. Cycles repeat every 21 days for 6-10 cycles in the absence of disease progression or unacceptable toxicity. Patients may continue enzalutamide PO QD on days 1-28 in the absence of disease progression or unacceptable toxicity. Cabazitaxel: Given IV Enzalutamide: Given PO Laboratory Biomarker Analysis: Correlative studies Pharmacological Study: Correlative studies Prednisone: Given PO
PSA Response 1, Defined as >= 90% PSA Decline From Baseline	55.6 percentage of subjects Interval 38.1 to 72.1

SECONDARY outcome

Timeframe: Up to 28 days after the last dose of study medication

Descriptive statistical analysis will be conducted. The proportion estimate will be reported with 95% confidence interval using exact method.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Up to 5 years

Descriptive statistical analysis will be conducted. The median overall survival will be estimated with 95% confidence interval (if available). Kaplan-Meier plot will be used to graphically illustrate the overall survival distribution.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Day 1 at 0.5, 1, 1.5, 2, 4, 8, and 24 hours after the start of cabazitaxel infusion of cycles 1 and 2 (each cycle is 21 days)

Mean plasma concentration (Cmax) will be plotted over time for cabazitaxel (day 1, cycle 1) and cabazitaxel co-administered with enzalutamide (day 1, cycle 2). Noncompartmental pharmacokinetic analysis will be performed on individual concentration-time data to calculate maximum concentration from 0 hours to last measurable concentration and to infinity, and half-life, for cabazitaxel administered alone or coadministered with enzalutamide.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Day 1 at 0.5, 1, 1.5, 2, 4, 8, and 24 hours after the start of cabazitaxel infusion of cycles 1 and 2 (each cycle is 21 days)

Mean area under the curve (AUC) will be plotted over time for cabazitaxel (day 1, cycle 1) and cabazitaxel co-administered with enzalutamide (day1, cycle 2). Noncompartmental pharmacokinetic analysis will be performed on individual concentration-time data to calculate AUC from 0 hours to last measurable concentration for cabazitaxel administered alone or coadministered with enzalutamide.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Day 1 at 0.5, 1, 1.5, 2, 4, 8, and 24 hours after the start of cabazitaxel infusion of cycles 1 and 2 (each cycle is 21 days)

Mean cabazitaxel half-life will be plotted over time for cabazitaxel (day 1, cycle 1) and cabazitaxel co-administered with enzalutamide (day1, cycle 2). Noncompartmental pharmacokinetic analysis will be performed on individual concentration-time data to calculate half-life from 0 hours to last measurable concentration for cabazitaxel administered alone or coadministered with enzalutamide.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Baseline to time of >= 50% PSA decline, assessed up to 68 weeks

The percentage of participants with a \>= 50% PSA decline from baseline will be reported with 95% confidence interval using exact method. 'PSA response' is based on Prostate Cancer Working Group 2's (PCWG2) recommendations, which do not offer a specific definition as no single degree of decline has been established.

Outcome measures

Outcome measures
Measure	Phase I - Treatment (Cabazitaxel, Enzalutamide) n=36 Participants Patients receive 25 mg/m2 cabazitaxel IV over 1 hour on day 1 and enzalutamide PO QD on days 1-21 (days 2-21 of cycle 1). Patients also receive prednisone PO BID as standard of care with cabazitaxel. Cycles repeat every 21 days for 6-10 cycles in the absence of disease progression or unacceptable toxicity. Patients may continue enzalutamide PO QD on days 1-28 in the absence of disease progression or unacceptable toxicity. Cabazitaxel: Given IV Enzalutamide: Given PO Laboratory Biomarker Analysis: Correlative studies Pharmacological Study: Correlative studies Prednisone: Given PO
PSA Response 2, Defined as >= 50% PSA Decline From Baseline	77.8 percentage of subjects Interval 60.8 to 89.9

SECONDARY outcome

Timeframe: Baseline to time of >= 30% PSA decline, assessed up to 68 weeks

The percentage of participants with a \>= 30% PSA decline from baseline will be reported with 95% confidence interval using exact method. 'PSA response' is based on Prostate Cancer Working Group 2's (PCWG2) recommendations, which do not offer a specific definition as no single degree of decline has been established.

Outcome measures

Outcome measures
Measure	Phase I - Treatment (Cabazitaxel, Enzalutamide) n=36 Participants Patients receive 25 mg/m2 cabazitaxel IV over 1 hour on day 1 and enzalutamide PO QD on days 1-21 (days 2-21 of cycle 1). Patients also receive prednisone PO BID as standard of care with cabazitaxel. Cycles repeat every 21 days for 6-10 cycles in the absence of disease progression or unacceptable toxicity. Patients may continue enzalutamide PO QD on days 1-28 in the absence of disease progression or unacceptable toxicity. Cabazitaxel: Given IV Enzalutamide: Given PO Laboratory Biomarker Analysis: Correlative studies Pharmacological Study: Correlative studies Prednisone: Given PO
PSA Response 3, Defined as >= 30% PSA Decline From Baseline	80.6 percentage of subjects Interval 64.0 to 91.8

Adverse Events

Phase I - Treatment (Cabazitaxel, Enzalutamide)

Serious events: 2 serious events

Other events: 3 other events

Deaths: 0 deaths

Phase II - Treatment (Cabazitaxel, Enzalutamide)

Serious events: 10 serious events

Other events: 33 other events

Deaths: 0 deaths

Serious adverse events

Other adverse events

Additional Information

Rachel Slottke, Program Manager

Oregon Health & Science University

Phone: 503-494-6117

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Measure	Phase I - Treatment (Cabazitaxel, Enzalutamide) n=3 participants at risk Patients receive 25 mg/m2 cabazitaxel IV over 1 hour on day 1 and enzalutamide PO QD on days 1-21 (days 2-21 of cycle 1). Patients also receive prednisone PO BID as standard of care with cabazitaxel. Cycles repeat every 21 days for 6-10 cycles in the absence of disease progression or unacceptable toxicity. Patients may continue enzalutamide PO QD on days 1-28 in the absence of disease progression or unacceptable toxicity. Cabazitaxel: Given IV Enzalutamide: Given PO Laboratory Biomarker Analysis: Correlative studies Pharmacological Study: Correlative studies Prednisone: Given PO	Phase II - Treatment (Cabazitaxel, Enzalutamide) n=33 participants at risk Patients receive 25 mg/m2 cabazitaxel IV over 1 hour on day 1 and enzalutamide PO QD on days 1-21 (days 2-21 of cycle 1). Patients also receive prednisone PO BID as standard of care with cabazitaxel. Cycles repeat every 21 days for 6-10 cycles in the absence of disease progression or unacceptable toxicity. Patients may continue enzalutamide PO QD on days 1-28 in the absence of disease progression or unacceptable toxicity. Cabazitaxel: Given IV Enzalutamide: Given PO Laboratory Biomarker Analysis: Correlative studies Pharmacological Study: Correlative studies Prednisone: Given PO
Blood and lymphatic system disorders Febrile neutropenia	0.00% 0/3 • Adverse events are recorded from the start of treatment administration to 30 days post treatment or resolution of the event, an average of 20 months. All adverse events, regardless of causality or relationship to study treatments or procedures, are reported.	3.0% 1/33 • Adverse events are recorded from the start of treatment administration to 30 days post treatment or resolution of the event, an average of 20 months. All adverse events, regardless of causality or relationship to study treatments or procedures, are reported.
Injury, poisoning and procedural complications Fracture	0.00% 0/3 • Adverse events are recorded from the start of treatment administration to 30 days post treatment or resolution of the event, an average of 20 months. All adverse events, regardless of causality or relationship to study treatments or procedures, are reported.	6.1% 2/33 • Adverse events are recorded from the start of treatment administration to 30 days post treatment or resolution of the event, an average of 20 months. All adverse events, regardless of causality or relationship to study treatments or procedures, are reported.
General disorders General disorders and administration site conditions - Other, failure to thrive	0.00% 0/3 • Adverse events are recorded from the start of treatment administration to 30 days post treatment or resolution of the event, an average of 20 months. All adverse events, regardless of causality or relationship to study treatments or procedures, are reported.	3.0% 1/33 • Adverse events are recorded from the start of treatment administration to 30 days post treatment or resolution of the event, an average of 20 months. All adverse events, regardless of causality or relationship to study treatments or procedures, are reported.
Nervous system disorders Seizure	0.00% 0/3 • Adverse events are recorded from the start of treatment administration to 30 days post treatment or resolution of the event, an average of 20 months. All adverse events, regardless of causality or relationship to study treatments or procedures, are reported.	3.0% 1/33 • Adverse events are recorded from the start of treatment administration to 30 days post treatment or resolution of the event, an average of 20 months. All adverse events, regardless of causality or relationship to study treatments or procedures, are reported.
Infections and infestations Urinary tract infection	0.00% 0/3 • Adverse events are recorded from the start of treatment administration to 30 days post treatment or resolution of the event, an average of 20 months. All adverse events, regardless of causality or relationship to study treatments or procedures, are reported.	3.0% 1/33 • Adverse events are recorded from the start of treatment administration to 30 days post treatment or resolution of the event, an average of 20 months. All adverse events, regardless of causality or relationship to study treatments or procedures, are reported.
Infections and infestations Infections and infestations - Other, influenza	33.3% 1/3 • Adverse events are recorded from the start of treatment administration to 30 days post treatment or resolution of the event, an average of 20 months. All adverse events, regardless of causality or relationship to study treatments or procedures, are reported.	0.00% 0/33 • Adverse events are recorded from the start of treatment administration to 30 days post treatment or resolution of the event, an average of 20 months. All adverse events, regardless of causality or relationship to study treatments or procedures, are reported.
Nervous system disorders Myelitis	33.3% 1/3 • Adverse events are recorded from the start of treatment administration to 30 days post treatment or resolution of the event, an average of 20 months. All adverse events, regardless of causality or relationship to study treatments or procedures, are reported.	0.00% 0/33 • Adverse events are recorded from the start of treatment administration to 30 days post treatment or resolution of the event, an average of 20 months. All adverse events, regardless of causality or relationship to study treatments or procedures, are reported.
Renal and urinary disorders Acute kidney injury	0.00% 0/3 • Adverse events are recorded from the start of treatment administration to 30 days post treatment or resolution of the event, an average of 20 months. All adverse events, regardless of causality or relationship to study treatments or procedures, are reported.	3.0% 1/33 • Adverse events are recorded from the start of treatment administration to 30 days post treatment or resolution of the event, an average of 20 months. All adverse events, regardless of causality or relationship to study treatments or procedures, are reported.
Musculoskeletal and connective tissue disorders Arthralgia	0.00% 0/3 • Adverse events are recorded from the start of treatment administration to 30 days post treatment or resolution of the event, an average of 20 months. All adverse events, regardless of causality or relationship to study treatments or procedures, are reported.	3.0% 1/33 • Adverse events are recorded from the start of treatment administration to 30 days post treatment or resolution of the event, an average of 20 months. All adverse events, regardless of causality or relationship to study treatments or procedures, are reported.
General disorders Back pain	0.00% 0/3 • Adverse events are recorded from the start of treatment administration to 30 days post treatment or resolution of the event, an average of 20 months. All adverse events, regardless of causality or relationship to study treatments or procedures, are reported.	3.0% 1/33 • Adverse events are recorded from the start of treatment administration to 30 days post treatment or resolution of the event, an average of 20 months. All adverse events, regardless of causality or relationship to study treatments or procedures, are reported.
Surgical and medical procedures Surgical and medical procedures - Other	0.00% 0/3 • Adverse events are recorded from the start of treatment administration to 30 days post treatment or resolution of the event, an average of 20 months. All adverse events, regardless of causality or relationship to study treatments or procedures, are reported.	3.0% 1/33 • Adverse events are recorded from the start of treatment administration to 30 days post treatment or resolution of the event, an average of 20 months. All adverse events, regardless of causality or relationship to study treatments or procedures, are reported.
Renal and urinary disorders hematuria	0.00% 0/3 • Adverse events are recorded from the start of treatment administration to 30 days post treatment or resolution of the event, an average of 20 months. All adverse events, regardless of causality or relationship to study treatments or procedures, are reported.	3.0% 1/33 • Adverse events are recorded from the start of treatment administration to 30 days post treatment or resolution of the event, an average of 20 months. All adverse events, regardless of causality or relationship to study treatments or procedures, are reported.
Infections and infestations Infections and infestations - Other, Cellulitis	0.00% 0/3 • Adverse events are recorded from the start of treatment administration to 30 days post treatment or resolution of the event, an average of 20 months. All adverse events, regardless of causality or relationship to study treatments or procedures, are reported.	3.0% 1/33 • Adverse events are recorded from the start of treatment administration to 30 days post treatment or resolution of the event, an average of 20 months. All adverse events, regardless of causality or relationship to study treatments or procedures, are reported.
Surgical and medical procedures Surgical and medical procedures- other: Lung Biopsy	0.00% 0/3 • Adverse events are recorded from the start of treatment administration to 30 days post treatment or resolution of the event, an average of 20 months. All adverse events, regardless of causality or relationship to study treatments or procedures, are reported.	3.0% 1/33 • Adverse events are recorded from the start of treatment administration to 30 days post treatment or resolution of the event, an average of 20 months. All adverse events, regardless of causality or relationship to study treatments or procedures, are reported.
Gastrointestinal disorders Proctitis	0.00% 0/3 • Adverse events are recorded from the start of treatment administration to 30 days post treatment or resolution of the event, an average of 20 months. All adverse events, regardless of causality or relationship to study treatments or procedures, are reported.	3.0% 1/33 • Adverse events are recorded from the start of treatment administration to 30 days post treatment or resolution of the event, an average of 20 months. All adverse events, regardless of causality or relationship to study treatments or procedures, are reported.
Gastrointestinal disorders Small intestinal obstruction	0.00% 0/3 • Adverse events are recorded from the start of treatment administration to 30 days post treatment or resolution of the event, an average of 20 months. All adverse events, regardless of causality or relationship to study treatments or procedures, are reported.	3.0% 1/33 • Adverse events are recorded from the start of treatment administration to 30 days post treatment or resolution of the event, an average of 20 months. All adverse events, regardless of causality or relationship to study treatments or procedures, are reported.