Trial Outcomes & Findings for Cabazitaxel and Prednisone in Treating Patients With Metastatic Hormone-Resistant Prostate Cancer (NCT NCT02844582)

Results Overview

The response rate will be compared to a historical response rate of 20% using the exact binomial test for a single proportion. Confidence intervals for the response rate will be calculated using Wilson's method.

Recruitment status

TERMINATED

Study phase

PHASE2

Target enrollment

2 participants

Primary outcome timeframe

Up to 18 months.

Results posted on

2021-01-25

Participant Flow

Participant milestones

Participant milestones
Measure	Treatment (Cabazitaxel, Prednisone) Patients receive cabazitaxel IV over 1 hour on day 1 and prednisone PO BID on days 1-21. Treatment repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity. Cabazitaxel: Given IV Prednisone: Given PO
Overall Study STARTED	2
Overall Study COMPLETED	2
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Cabazitaxel and Prednisone in Treating Patients With Metastatic Hormone-Resistant Prostate Cancer

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Treatment (Cabazitaxel, Prednisone) n=2 Participants Patients receive cabazitaxel IV over 1 hour on day 1 and prednisone PO BID on days 1-21. Treatment repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity. Cabazitaxel: Given IV Prednisone: Given PO
Age, Categorical <=18 years	0 Participants n=39 Participants
Age, Categorical Between 18 and 65 years	1 Participants n=39 Participants
Age, Categorical >=65 years	1 Participants n=39 Participants
Sex: Female, Male Female	0 Participants n=39 Participants
Sex: Female, Male Male	2 Participants n=39 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=39 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	2 Participants n=39 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=39 Participants
Region of Enrollment United States	2 participants n=39 Participants

PRIMARY outcome

Timeframe: Up to 18 months.

Population: The study was stopped due to poor accrual, and only 2 patients received study treatment. PSA was collected, but the number of evaluable patients was insufficient to perform analysis of this outcome measure.

The response rate will be compared to a historical response rate of 20% using the exact binomial test for a single proportion. Confidence intervals for the response rate will be calculated using Wilson's method.

Outcome measures

Outcome measures
Measure	Treatment (Cabazitaxel, Prednisone) n=2 Participants Patients receive cabazitaxel IV over 1 hour on day 1 and prednisone PO BID on days 1-21. Treatment repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity. Cabazitaxel: Given IV Prednisone: Given PO
PSA Response Rate, Defined as >= 50% Decline in PSA From Baseline Maintained for at Least 3 Weeks and Measured by the Same Laboratory, and Without Evidence of Other Disease Progression Documented at Time of Confirmatory Values	0 Participants

SECONDARY outcome

Timeframe: Up to 28 days after discontinuation of study drug

Incidence of adverse events, serious adverse events, and discontinuations, described and graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events version 4.03

Outcome measures

Outcome measures
Measure	Treatment (Cabazitaxel, Prednisone) n=2 Participants Patients receive cabazitaxel IV over 1 hour on day 1 and prednisone PO BID on days 1-21. Treatment repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity. Cabazitaxel: Given IV Prednisone: Given PO
Incidence of Adverse Events, Serious Adverse Events, and Discontinuations, Described and Graded According to the National Cancer Institute Common Terminology Criteria for Adverse Events Version 4.03 Back pain	1 participants
Incidence of Adverse Events, Serious Adverse Events, and Discontinuations, Described and Graded According to the National Cancer Institute Common Terminology Criteria for Adverse Events Version 4.03 Diarrhea	1 participants
Incidence of Adverse Events, Serious Adverse Events, and Discontinuations, Described and Graded According to the National Cancer Institute Common Terminology Criteria for Adverse Events Version 4.03 Fatigue	2 participants
Incidence of Adverse Events, Serious Adverse Events, and Discontinuations, Described and Graded According to the National Cancer Institute Common Terminology Criteria for Adverse Events Version 4.03 Hot flashes	1 participants
Incidence of Adverse Events, Serious Adverse Events, and Discontinuations, Described and Graded According to the National Cancer Institute Common Terminology Criteria for Adverse Events Version 4.03 Neutrophil count decreased	2 participants
Incidence of Adverse Events, Serious Adverse Events, and Discontinuations, Described and Graded According to the National Cancer Institute Common Terminology Criteria for Adverse Events Version 4.03 Non-cardiac chest pain	1 participants
Incidence of Adverse Events, Serious Adverse Events, and Discontinuations, Described and Graded According to the National Cancer Institute Common Terminology Criteria for Adverse Events Version 4.03 Pain	1 participants
Incidence of Adverse Events, Serious Adverse Events, and Discontinuations, Described and Graded According to the National Cancer Institute Common Terminology Criteria for Adverse Events Version 4.03 Renal and urinary disorders - Other, specify	1 participants
Incidence of Adverse Events, Serious Adverse Events, and Discontinuations, Described and Graded According to the National Cancer Institute Common Terminology Criteria for Adverse Events Version 4.03 White blood cell decreased	2 participants

SECONDARY outcome

Timeframe: Up to 18 months.

Population: Study was terminated prematurely and data was not collected to assess this outcome measure.

Confidence intervals for the response rate will be calculated using Wilson's method. Medians will be estimated using the method of Kaplan and Meier, with confidence intervals estimated using Greenwood's method.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Approximately 5 months.

Population: Study was terminated prematurely and insufficient data was collected to assess this outcome measure.

Confidence intervals for the response rate will be calculated using Wilson's method. Medians will be estimated using the method of Kaplan and Meier, with confidence intervals estimated using Greenwood's method.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Approximately 5 months.

Population: Study was terminated prematurely and insufficient data was collected to assess this outcome measure.

Confidence intervals for the response rate will be calculated using Wilson's method. Medians will be estimated using the method of Kaplan and Meier, with confidence intervals estimated using Greenwood's method.

Outcome measures

Outcome data not reported

Adverse Events

Treatment (Cabazitaxel, Prednisone)

Serious events: 0 serious events

Other events: 2 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Treatment (Cabazitaxel, Prednisone) n=2 participants at risk Patients receive cabazitaxel IV over 1 hour on day 1 and prednisone PO BID on days 1-21. Treatment repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity. Cabazitaxel: Given IV Prednisone: Given PO
Musculoskeletal and connective tissue disorders Back pain	50.0% 1/2 • Up to 28 days after discontinuation of study drug. Number of Participants with Adverse Events.
Gastrointestinal disorders Diarrhea	50.0% 1/2 • Up to 28 days after discontinuation of study drug. Number of Participants with Adverse Events.
General disorders Fatigue	100.0% 2/2 • Up to 28 days after discontinuation of study drug. Number of Participants with Adverse Events.
Nervous system disorders Headache	50.0% 1/2 • Up to 28 days after discontinuation of study drug. Number of Participants with Adverse Events.
Vascular disorders Hot flashes	50.0% 1/2 • Up to 28 days after discontinuation of study drug. Number of Participants with Adverse Events.
Investigations Neutrophil count decreased	100.0% 2/2 • Up to 28 days after discontinuation of study drug. Number of Participants with Adverse Events.
General disorders Non-cardiac chest pain	50.0% 1/2 • Up to 28 days after discontinuation of study drug. Number of Participants with Adverse Events.
General disorders Pain	50.0% 1/2 • Up to 28 days after discontinuation of study drug. Number of Participants with Adverse Events.
Renal and urinary disorders Renal and urinary disorders - Other, specify	50.0% 1/2 • Up to 28 days after discontinuation of study drug. Number of Participants with Adverse Events.
Investigations White blood cell decreased	100.0% 2/2 • Up to 28 days after discontinuation of study drug. Number of Participants with Adverse Events.

Additional Information

Analyst

University of California, Davis

Phone: 916-734-8053

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place