Trial Outcomes & Findings for A Safety and Efficacy Study of Enzalutamide in Indian Patients With Progressive Metastatic Castration-Resistant Prostate Cancer (mCRPC) Previously Treated With Docetaxel-Based Chemotherapy (NCT NCT03641560)
NCT ID: NCT03641560
Last Updated: 2025-04-08
Results Overview
An AE was defined as any untoward medical occurrence in a participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An AE could therefore be any unfavorable \& unintended sign (including an abnormal laboratory finding \[e.g. hematology, clinical chemistry, or urinalysis or other safety assessment e.g., ECGs, radiographic scans, vital signs measurements, physical examination\]), symptom, or disease (new or exacerbated) temporally associated with the use of a medicinal product. TEAE was defined as an adverse event observed after starting administration of the study drug.
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
52 participants
Primary outcome timeframe
From first dose of study drug until 30 days after last dose (Up to 1899 days)
Results posted on
2025-04-08
Participant Flow
Indian male participants with progressive mCRPC previously treated with docetaxel-based chemotherapy were enrolled in this study.
Eligible participants who met inclusion criteria and none of the exclusion criteria were enrolled.
Participant milestones
| Measure |
Enzalutamide
Participants with progressive mCRPC who had previously been treated with docetaxel-based chemotherapy received 160 milligrams (mg) (4 capsules of 40 mg) enzalutamide orally, once daily until disease progression, unacceptable toxicity or any other discontinuation criteria were met.
|
|---|---|
|
Overall Study
STARTED
|
52
|
|
Overall Study
COMPLETED
|
0
|
|
Overall Study
NOT COMPLETED
|
52
|
Reasons for withdrawal
| Measure |
Enzalutamide
Participants with progressive mCRPC who had previously been treated with docetaxel-based chemotherapy received 160 milligrams (mg) (4 capsules of 40 mg) enzalutamide orally, once daily until disease progression, unacceptable toxicity or any other discontinuation criteria were met.
|
|---|---|
|
Overall Study
Withdrawal by Subject
|
6
|
|
Overall Study
Progressive disease
|
40
|
|
Overall Study
Death
|
6
|
Baseline Characteristics
A Safety and Efficacy Study of Enzalutamide in Indian Patients With Progressive Metastatic Castration-Resistant Prostate Cancer (mCRPC) Previously Treated With Docetaxel-Based Chemotherapy
Baseline characteristics by cohort
| Measure |
Enzalutamide
n=52 Participants
Participants with progressive mCRPC who had previously been treated with docetaxel-based chemotherapy received 160 milligrams (mg) (4 capsules of 40 mg) enzalutamide orally, once daily until disease progression, unacceptable toxicity or any other discontinuation criteria were met.
|
|---|---|
|
Age, Continuous
|
66.5 Years
STANDARD_DEVIATION 8.4 • n=93 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=93 Participants
|
|
Sex: Female, Male
Male
|
52 Participants
n=93 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
3 Participants
n=93 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
43 Participants
n=93 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
6 Participants
n=93 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=93 Participants
|
|
Race (NIH/OMB)
Asian
|
52 Participants
n=93 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=93 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=93 Participants
|
|
Race (NIH/OMB)
White
|
0 Participants
n=93 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=93 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=93 Participants
|
PRIMARY outcome
Timeframe: From first dose of study drug until 30 days after last dose (Up to 1899 days)Population: SAF
An AE was defined as any untoward medical occurrence in a participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An AE could therefore be any unfavorable \& unintended sign (including an abnormal laboratory finding \[e.g. hematology, clinical chemistry, or urinalysis or other safety assessment e.g., ECGs, radiographic scans, vital signs measurements, physical examination\]), symptom, or disease (new or exacerbated) temporally associated with the use of a medicinal product. TEAE was defined as an adverse event observed after starting administration of the study drug.
Outcome measures
| Measure |
Enzalutamide
n=52 Participants
Participants with progressive mCRPC who had previously been treated with docetaxel-based chemotherapy received 160 milligrams (mg) (4 capsules of 40 mg) enzalutamide orally, once daily until disease progression, unacceptable toxicity or any other discontinuation criteria were met.
|
|---|---|
|
Number of Participants With Treatment- Emergent Adverse Events (TEAEs)
|
36 Participants
|
SECONDARY outcome
Timeframe: Baseline (Day 1); Days 29, 57, 85, 169 and then every 84 days until 30 days after the last dose (up to Day 1899)Population: Full Analysis Set (FAS): The FAS consisted of all participants who received at least one dose of study drug and had at least one post baseline measurement.
Confirmed PSA response rate was defined as the percentage of participants with \>= 50% decline in PSA from baseline to the lowest postbaseline PSA result, with a consecutive assessment conducted at least 3 weeks later to confirm the PSA response.
Outcome measures
| Measure |
Enzalutamide
n=50 Participants
Participants with progressive mCRPC who had previously been treated with docetaxel-based chemotherapy received 160 milligrams (mg) (4 capsules of 40 mg) enzalutamide orally, once daily until disease progression, unacceptable toxicity or any other discontinuation criteria were met.
|
|---|---|
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Percentage of Participants With Confirmed Prostate-specific Antigen (PSA) Response
|
46 Percentage of Participants
|
Adverse Events
Enzalutamide
Serious events: 10 serious events
Other events: 25 other events
Deaths: 6 deaths
Serious adverse events
| Measure |
Enzalutamide
n=52 participants at risk
Participants with progressive mCRPC who had previously been treated with docetaxel-based chemotherapy received 160 milligrams (mg) (4 capsules of 40 mg) enzalutamide orally, once daily until disease progression, unacceptable toxicity or any other discontinuation criteria were met.
|
|---|---|
|
Cardiac disorders
Cardiac arrest
|
1.9%
1/52 • Number of events 1 • From first dose of study drug until 30 days after last dose (Up to 1899 days)
The Safety analysis set (SAF) consisted of all participants who took at least one dose of the study drug.
|
|
Cardiac disorders
Cardio-respiratory arrest
|
1.9%
1/52 • Number of events 1 • From first dose of study drug until 30 days after last dose (Up to 1899 days)
The Safety analysis set (SAF) consisted of all participants who took at least one dose of the study drug.
|
|
Cardiac disorders
Myocardial ischaemia
|
1.9%
1/52 • Number of events 1 • From first dose of study drug until 30 days after last dose (Up to 1899 days)
The Safety analysis set (SAF) consisted of all participants who took at least one dose of the study drug.
|
|
General disorders
Asthenia
|
1.9%
1/52 • Number of events 1 • From first dose of study drug until 30 days after last dose (Up to 1899 days)
The Safety analysis set (SAF) consisted of all participants who took at least one dose of the study drug.
|
|
General disorders
Chest discomfort
|
1.9%
1/52 • Number of events 1 • From first dose of study drug until 30 days after last dose (Up to 1899 days)
The Safety analysis set (SAF) consisted of all participants who took at least one dose of the study drug.
|
|
General disorders
Multiple organ dysfunction syndrome
|
1.9%
1/52 • Number of events 2 • From first dose of study drug until 30 days after last dose (Up to 1899 days)
The Safety analysis set (SAF) consisted of all participants who took at least one dose of the study drug.
|
|
Infections and infestations
Lower respiratory tract infection
|
1.9%
1/52 • Number of events 1 • From first dose of study drug until 30 days after last dose (Up to 1899 days)
The Safety analysis set (SAF) consisted of all participants who took at least one dose of the study drug.
|
|
Infections and infestations
Pneumonia
|
1.9%
1/52 • Number of events 1 • From first dose of study drug until 30 days after last dose (Up to 1899 days)
The Safety analysis set (SAF) consisted of all participants who took at least one dose of the study drug.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
1.9%
1/52 • Number of events 1 • From first dose of study drug until 30 days after last dose (Up to 1899 days)
The Safety analysis set (SAF) consisted of all participants who took at least one dose of the study drug.
|
|
Nervous system disorders
Hypoxic-ischaemic encephalopathy
|
1.9%
1/52 • Number of events 1 • From first dose of study drug until 30 days after last dose (Up to 1899 days)
The Safety analysis set (SAF) consisted of all participants who took at least one dose of the study drug.
|
|
Renal and urinary disorders
Haematuria
|
1.9%
1/52 • Number of events 1 • From first dose of study drug until 30 days after last dose (Up to 1899 days)
The Safety analysis set (SAF) consisted of all participants who took at least one dose of the study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Bronchial hyperreactivity
|
1.9%
1/52 • Number of events 1 • From first dose of study drug until 30 days after last dose (Up to 1899 days)
The Safety analysis set (SAF) consisted of all participants who took at least one dose of the study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
3.8%
2/52 • Number of events 2 • From first dose of study drug until 30 days after last dose (Up to 1899 days)
The Safety analysis set (SAF) consisted of all participants who took at least one dose of the study drug.
|
|
Vascular disorders
Hypotension
|
1.9%
1/52 • Number of events 1 • From first dose of study drug until 30 days after last dose (Up to 1899 days)
The Safety analysis set (SAF) consisted of all participants who took at least one dose of the study drug.
|
Other adverse events
| Measure |
Enzalutamide
n=52 participants at risk
Participants with progressive mCRPC who had previously been treated with docetaxel-based chemotherapy received 160 milligrams (mg) (4 capsules of 40 mg) enzalutamide orally, once daily until disease progression, unacceptable toxicity or any other discontinuation criteria were met.
|
|---|---|
|
Gastrointestinal disorders
Constipation
|
13.5%
7/52 • Number of events 8 • From first dose of study drug until 30 days after last dose (Up to 1899 days)
The Safety analysis set (SAF) consisted of all participants who took at least one dose of the study drug.
|
|
Gastrointestinal disorders
Nausea
|
5.8%
3/52 • Number of events 3 • From first dose of study drug until 30 days after last dose (Up to 1899 days)
The Safety analysis set (SAF) consisted of all participants who took at least one dose of the study drug.
|
|
Gastrointestinal disorders
Vomiting
|
5.8%
3/52 • Number of events 4 • From first dose of study drug until 30 days after last dose (Up to 1899 days)
The Safety analysis set (SAF) consisted of all participants who took at least one dose of the study drug.
|
|
General disorders
Asthenia
|
9.6%
5/52 • Number of events 7 • From first dose of study drug until 30 days after last dose (Up to 1899 days)
The Safety analysis set (SAF) consisted of all participants who took at least one dose of the study drug.
|
|
General disorders
Pain
|
13.5%
7/52 • Number of events 7 • From first dose of study drug until 30 days after last dose (Up to 1899 days)
The Safety analysis set (SAF) consisted of all participants who took at least one dose of the study drug.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
13.5%
7/52 • Number of events 7 • From first dose of study drug until 30 days after last dose (Up to 1899 days)
The Safety analysis set (SAF) consisted of all participants who took at least one dose of the study drug.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
5.8%
3/52 • Number of events 3 • From first dose of study drug until 30 days after last dose (Up to 1899 days)
The Safety analysis set (SAF) consisted of all participants who took at least one dose of the study drug.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
13.5%
7/52 • Number of events 7 • From first dose of study drug until 30 days after last dose (Up to 1899 days)
The Safety analysis set (SAF) consisted of all participants who took at least one dose of the study drug.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
5.8%
3/52 • Number of events 4 • From first dose of study drug until 30 days after last dose (Up to 1899 days)
The Safety analysis set (SAF) consisted of all participants who took at least one dose of the study drug.
|
Additional Information
Clinical Transparency
Astellas Global Development, Inc. (APGD)
Phone: 800-888-7704
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee Institute and/or Principal Investigator may publish trial data generated at their specific study site after Sponsor publication of the multi-center data. Sponsor must receive a site's manuscript prior to publication for review and comment as specified in the Investigator Agreement.
- Publication restrictions are in place
Restriction type: OTHER