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The purpose of this study was to evaluate the safety and tolerability of enzalutamide in Indian patients with progressive mCRPC previously treated with docetaxel-based chemotherapy. This study also evaluated the effect of enzalutamide on prostate-specific antigen (PSA).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Enzalutamide | Experimental | 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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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Enzalutamide | Drug | Enzalutamide was administered orally |
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| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Treatment- Emergent Adverse Events (TEAEs) | 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. | From first dose of study drug until 30 days after last dose (Up to 1899 days) |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants With Confirmed Prostate-specific Antigen (PSA) Response | 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. | Baseline (Day 1); Days 29, 57, 85, 169 and then every 84 days until 30 days after the last dose (up to Day 1899) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Central Contact | Astellas Pharma Inc | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Site IN00002 | Ahmedabad | India | ||||
| Site IN00004 |
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| Label | URL |
|---|---|
| Link to results and other applicable study documents on the Astellas Clinical Trials website | View source |
| Link to plain language summary of the study on the Trial Results Summaries website | View source |
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Access to anonymized individual participant level data collected during the study, in addition to study-related supporting documentation, is planned for studies conducted with approved product indications and formulations, as well as products terminated during development. Studies conducted with product indications or formulations that remain active in development are assessed after study completion to determine if Individual Participant Data can be shared. Further details on Astellas' data sharing policy can be found at https://www.clinicaltrials.astellas.com/transparency/.
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Eligible participants who met inclusion criteria and none of the exclusion criteria were enrolled.
Indian male participants with progressive mCRPC previously treated with docetaxel-based chemotherapy were enrolled in this study.
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | May 31, 2018 | Jan 22, 2025 |
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| Androgen deprivation therapy (ADT) | Drug | All participants were required to maintain ADT during study treatment, either using a Gonadotropin Releasing Hormone (GnRH) agonist/antagonist or having a history of bilateral orchiectomy |
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| Hubli |
| India |
| Site IN00008 | Kolkata | India |
| Site IN00003 | Nashik | India |
| Site IN00007 | Nashik | India |
| Site IN00010 | New Delhi | India |
| Site IN00001 | Pune | India |
| Site IN00011 | Surat | India |
| COMPLETED |
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| NOT COMPLETED |
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Safety Analysis Set (SAF): The SAF consisted of all participants who took at least 1 dose of study drug, and was used for safety analyses.
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | Years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Number of Participants With Treatment- Emergent Adverse Events (TEAEs) | 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. | SAF | Posted | Number | Participants | From first dose of study drug until 30 days after last dose (Up to 1899 days) |
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| Secondary | Percentage of Participants With Confirmed Prostate-specific Antigen (PSA) Response | 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. | 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. | Posted | Number | Percentage of Participants | Baseline (Day 1); Days 29, 57, 85, 169 and then every 84 days until 30 days after the last dose (up to Day 1899) |
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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.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. | 6 | 52 | 10 | 52 | 25 | 52 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Cardiac arrest | Cardiac disorders | MedDRA v26.0 | Systematic Assessment |
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| Cardio-respiratory arrest | Cardiac disorders | MedDRA v26.0 | Systematic Assessment |
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| Myocardial ischaemia | Cardiac disorders | MedDRA v26.0 | Systematic Assessment |
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| Asthenia | General disorders | MedDRA v26.0 | Systematic Assessment |
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| Chest discomfort | General disorders | MedDRA v26.0 | Systematic Assessment |
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| Multiple organ dysfunction syndrome | General disorders | MedDRA v26.0 | Systematic Assessment |
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| Lower respiratory tract infection | Infections and infestations | MedDRA v26.0 | Systematic Assessment |
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| Pneumonia | Infections and infestations | MedDRA v26.0 | Systematic Assessment |
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| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA v26.0 | Systematic Assessment |
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| Hypoxic-ischaemic encephalopathy | Nervous system disorders | MedDRA v26.0 | Systematic Assessment |
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| Haematuria | Renal and urinary disorders | MedDRA v26.0 | Systematic Assessment |
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| Bronchial hyperreactivity | Respiratory, thoracic and mediastinal disorders | MedDRA v26.0 | Systematic Assessment |
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| Respiratory failure | Respiratory, thoracic and mediastinal disorders | MedDRA v26.0 | Systematic Assessment |
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| Hypotension | Vascular disorders | MedDRA v26.0 | Systematic Assessment |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Constipation | Gastrointestinal disorders | MedDRA v26.0 | Systematic Assessment |
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| Nausea | Gastrointestinal disorders | MedDRA v26.0 | Systematic Assessment |
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| Vomiting | Gastrointestinal disorders | MedDRA v26.0 | Systematic Assessment |
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| Asthenia | General disorders | MedDRA v26.0 | Systematic Assessment |
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| Pain | General disorders | MedDRA v26.0 | Systematic Assessment |
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| Decreased appetite | Metabolism and nutrition disorders | MedDRA v26.0 | Systematic Assessment |
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| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA v26.0 | Systematic Assessment |
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| Back pain | Musculoskeletal and connective tissue disorders | MedDRA v26.0 | Systematic Assessment |
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| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA v26.0 | Systematic Assessment |
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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.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Clinical Transparency | Astellas Global Development, Inc. (APGD) | 800-888-7704 | astellas.resultsdisclosure@astellas.com |
| Prot_002.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Feb 26, 2024 | Jan 22, 2025 | SAP_003.pdf |
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| ID | Term |
|---|---|
| C540278 | enzalutamide |
| D000726 | Androgen Antagonists |
| ID | Term |
|---|---|
| D006727 | Hormone Antagonists |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |
| D045505 | Physiological Effects of Drugs |
| D020228 | Pharmacologic Actions |
| D020164 | Chemical Actions and Uses |
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| Unknown or Not Reported |
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| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
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| White |
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| More than one race |
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| Unknown or Not Reported |
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