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| Name | Class |
|---|---|
| Medivation LLC, a wholly owned subsidiary of Pfizer Inc. | INDUSTRY |
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The purpose of this study was to explore the safety and tolerability of enzalutamide in combination with abiraterone acetate plus prednisone. Subjects diagnosed with cancer of the prostate that was getting worse and spreading to the bone despite receiving hormone treatment were enrolled and received study treatment until disease progression.
For the study duration, all subjects maintained androgen deprivation with a gonadotropin releasing hormone (GnRH) agonist or antagonist or orchiectomy. Study drug was administered until disease progression. Disease progression was defined as a composite endpoint consisting of either clinical deterioration, radiographic progression or prostate-specific antigen (PSA) progression according to the Prostate Cancer Clinical Trials Working Group 2 (PCWG2) criteria.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Enzalutamide + Abiraterone + Prednisone | Experimental | Participants received enzalutamide combined with abiraterone acetate once daily plus prednisone twice daily. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| enzalutamide | Drug | Participants received 160 mg of enzalutamide orally once daily (4 capsules, 40 mg each). |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Adverse Events (AEs) | A treatment-emergent adverse event (TEAE) was defined as an adverse event occurring or worsening between the start of study treatment date and the latest date of 30 days after the last dose date or the 30-day follow-up visit date, and not later than the data cut-off date or the date of death. AEs, including abnormal clinical laboratory values, were graded using the National Cancer Institute-Common Terminology Criteria for Adverse Events (NCI-CTCAE) guidelines (V4.03). | From the first dose of study drug administration up 30 days following the last dose of study drug date, with a median duration of treatment of 10.1 months. |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in Testosterone Concentration in Bone Marrow Aspirate | Testosterone concentration in bone marrow aspirate was measured by laboratory results derived from bone marrow samples processed through liquid chromatography mass spectrometry. | Baseline and Week 9 |
| Change From Baseline in Dihydrotestosterone (DHT) Concentration in Bone Marrow Aspirate |
| Measure | Description | Time Frame |
|---|---|---|
| Androgen Receptor Signaling Assessed by Expression and Localization of Androgen Receptor (AR), CYP17 Expression, Splice Variants, and Pathways Linked With Non-classical AR Signaling and Bone Development | The endpoint was considered exploratory and no analysis was planned. | Baseline and Week 9 |
Inclusion Criteria:
Histologically or cytologically confirmed adenocarcinoma of the prostate without neuroendocrine differentiation or small cell features
Presence of metastatic disease to the bone
Ongoing androgen deprivation therapy with a gonadotropin releasing hormone (GnRH) analogue or orchiectomy (i.e., surgical or medical castration)
Subject receiving bisphosphonate or denosumab therapy must have been on stable doses for at least 4 weeks prior to Day 1
Progressive disease defined as one or more of the following three criteria (Note: subjects who received an antiandrogen must demonstrate disease progression following discontinuation of antiandrogen):
Subject previously treated with chemotherapy must have no more than two prior chemotherapy regimens for the treatment of metastatic prostate cancer
Eastern Cooperative Oncology Group (ECOG) performance status of 0-2
Agree to use a double-barrier method of contraception which involves the use of a condom in combination with one of the following: contraceptive sponge, diaphragm, or cervical ring with spermicidal gel or foam, if having sex with a woman of child-bearing potential during the length of the study and for one week after abiraterone is discontinued and for at least three months after enzalutamide is discontinued
Subject agrees not to participate in another interventional study while on treatment
Exclusion Criteria:
Known or suspected metastases in the brain
Absolute neutrophil count < 1,000/μL, platelet count < 75,000/μL, and hemoglobin < 9 g/dL (NOTE: subject may not have received any growth factors or blood transfusions within seven days of the hematologic laboratory values obtained at the Screening visit)
Total bilirubin (TBL), alanine aminotransferase (ALT) or aspartate aminotransferase (AST) > 2.5 times the upper limit of normal
Creatinine (Cr) > 2 mg/dL
Treatment with androgen receptor antagonists (bicalutamide, flutamide, nilutamide), 5-α reductase inhibitors (finasteride, dutasteride), estrogens, chemotherapy, or biologic therapy within 4 weeks of Day 1 visit
Radiation therapy within 3 weeks (if single fraction of radiotherapy within 2 weeks) of Day 1 visit, or radionuclide therapy within 8 weeks of Day 1
Planned palliative procedures for alleviation of bone pain such as radiation therapy or surgery
Structurally unstable bone lesions suggesting impending fracture
History of seizure or any condition that may predispose to seizure including, but not limited to underlying brain injury, stroke, primary brain tumors, brain metastases, or alcoholism. Also, history of loss of consciousness or transient ischemic attack within 12 months of enrollment (Day 1 visit)
Clinically significant cardiovascular disease including:
Prior use of ketoconazole, abiraterone acetate or enzalutamide, or participation in a previous clinical trial of ketoconazole, abiraterone acetate or enzalutamide
History of significant bleeding disorder unrelated to cancer, including:
Active or symptomatic viral hepatitis or chronic liver disease
Known history of pituitary or adrenal dysfunction
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| Name | Affiliation | Role |
|---|---|---|
| Associate Medical Director | Astellas Pharma Global Development | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Site US2492 MD Anderson Cancer Ctr | Houston | Texas | 77030 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 26343110 | Derived | Assi R, Temraz S, Shamseddine A, Mukherji D. New Compounds Targeting the Androgen Receptor for Treatment of Advanced Prostate Cancer. Curr Drug Targets. 2016;17(3):290-302. doi: 10.2174/1389450116666150907101044. |
| Label | URL |
|---|---|
| Link to results on the Astellas Clinical Study Results 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/.
Access to participant level data is offered to researchers after publication of the primary manuscript (if applicable) and is available as long as Astellas has legal authority to provide the data.
Researchers must submit a proposal to conduct a scientifically relevant analysis of the study data. The research proposal is reviewed by an Independent Research Panel. If the proposal is approved, access to the study data is provided in a secure data sharing environment after receipt of a signed Data Sharing Agreement.
All eligible participants who met inclusion criteria and none of the exclusion criteria were enrolled. A total of 64 participants were screened for eligibility.
All participants in this all male study were enrolled at 1 site in the United States (US).
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| ID | Title | Description |
|---|---|---|
| FG000 | Enzalutamide + Abiraterone + Prednisone | Participants received enzalutamide combined with abiraterone acetate once daily plus prednisone twice daily. |
| 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 | Jun 18, 2014 | Dec 13, 2018 |
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| abiraterone acetate | Drug | Participants received 1000 mg of abiraterone acetate orally once daily (4 tablets, 250 mg each). |
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| prednisone | Drug | Participants received 5 mg of prednisone orally twice daily (2 tablets, 5 mg each). |
|
DHT concentration in bone marrow aspirate was to be measured by laboratory results derived from bone marrow samples processed through liquid chromatography mass spectrometry. DHT bone data were not collected. |
| Baseline and Week 9 |
| Change From Baseline in Cortisol in Bone Marrow Aspirate | Cortisol in bone marrow aspirate was measured by laboratory results derived from bone marrow samples. | Baseline and Week 9 |
| Change From Baseline in Androstenedione in Bone Marrow Aspirate | Androstenedione in bone marrow aspirate was measured by laboratory results derived from bone marrow samples. | Baseline and Week 9 |
| Change From Baseline in Progesterone in Bone Marrow Aspirate | Progesterone in bone marrow aspirate was measured by laboratory results derived from bone marrow samples. | Baseline and Week 9 |
| Change From Baseline in Pregnenolone in Bone Marrow Aspirate | Pregnenolone in bone marrow aspirate was measured by laboratory results derived from bone marrow samples. | Baseline and Week 9 |
| Change From Baseline in Testosterone Concentration in Blood | Testosterone concentration in blood was measured by laboratory results derived from plasma samples. Plasma samples were derived from collected blood samples processed through liquid chromatography mass spectrometry. | Baseline and Week 9 |
| Change From Baseline in DHT Concentration in Blood | DHT concentration in blood was measured by laboratory results derived from plasma samples. Plasma samples were derived from collected blood samples processed through liquid chromatography mass spectrometry. The endpoint could not be analyzed since no participants had DHT levels over the lower limit of quantification (LLOQ). | Baseline and Week 9 |
| Change From Baseline in Cortisol Concentration in Blood | Cortisol concentration in blood was measured by laboratory results derived from plasma samples. Plasma samples were derived from collected blood samples processed through liquid chromatography mass spectrometry. | Baseline and Week 9 |
| Change From Baseline in Androstenedione Concentration in Blood | Androstenedione concentration in blood was measured by laboratory results derived from plasma samples. Plasma samples were derived from collected blood samples processed through liquid chromatography mass spectrometry. | Baseline and Week 9 |
| Change From Baseline in Progesterone Concentration in Blood | Progesterone concentration in blood was measured by laboratory results derived from plasma samples. Plasma samples were derived from collected blood samples processed through liquid chromatography mass spectrometry. | Baseline and Week 9 |
| Change From Baseline in Pregnenolone Concentration in Blood | Pregnenolone concentration in blood was measured by laboratory results derived from plasma samples. Plasma samples were derived from collected blood samples processed through liquid chromatography mass spectrometry. | Baseline and Week 9 |
| Change From Baseline to End-of-Treatment (EoT) in Prostate-Specific Antigen (PSA) Levels | Prostate-specific antigen progression by Prostate Cancer Clinical Trials Working Group 2 (PCWG2) was defined as a PSA increase ≥25% and ≥2 ng/ml above the post-baseline nadir, and which was confirmed by the first subsequent value of 3 or more weeks later. | Baseline and EoT; the median duration of treatment was 10.1 months. |
| Progression Free Survival (PFS) | PFS was measured as the time from the date of first dose of any drug of the study combination treatment until the first evidence of documented progression (a composite endpoint consisting of radiographic progression or PSA progression by PCWG2 or clinical deterioration) or death in the absence of progression (whichever came first) or the date last known to be progression free. The Kaplan-Meier (KM) 95% CI was based on Brookmeyer and Crowley robust non-parametric method. | Up to 1849 days |
| Percentage of Participants With Objective Response for Soft Tissue Lesions According to Response Evaluation Criteria in Solid Tumors 1.1 (RECIST) | Objective response was based on RECIST version 1.1 for soft tissue lesion on Magnetic resonance imaging (MRI) / Computerized tomography (CT) and the PCWG2 guidelines for bone lesions on bone scans and was defined as partial response (PR) or complete response (CR) based on the investigators' assessments of target, non-target and new lesions while on study treatment. The 95% for objective response rate was based on exact binomial 95% confidence interval (Clopper-Pearson). | Up to 1849 days |
| Bone Scan Response at EoT | PD: ≥1 of 3 criteria: PSA progression: ≥2 rising PSA levels, interval of ≥1 week between each determination. Soft tissue disease progression: RECIST 1.1. Bone disease progression: PCWG2 criteria (≥2 or new lesions on bone scan compared with prior scan). Target lesion CR: disappearance of all target lesions, PR as ≥30% decrease in sum of longest diameter (LD) of target lesions, referencing baseline sum LD, SD: neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, referencing smallest sum LD since treatment start, PD ≥20% increase in sum of LD of target lesions, referencing smallest sum LD recorded since treatment start or appearance of ≥1 new lesions. Non-target lesions CR: disappearance of all non-target lesions and normalization of tumor marker level, SD: persistence of ≥1 non-target lesions and/or maintenance of tumor marker level above normal limits, PD: appearance of ≥1 new lesions and/or unequivocal progression of existing non-target lesions. | EoT; the median duration of treatment was 10.1 months. |
| Change From Baseline to EoT in Bone Specific Alkaline Phosphatase | Bone metabolism marker bone specific alkaline phosphatase levels were derived from blood samples collected. | Baseline and EoT; the median duration of treatment was 10.1 months. |
| Change From Baseline in Urine N-Telopeptide | Bone metabolism marker urine N-telopeptide levels were derived from urine samples collected. | Baseline and Week 9 |
| Treated |
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| COMPLETED |
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| NOT COMPLETED |
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The analysis population for all baseline measures consisted of all participants who were enrolled in the study.
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| ID | Title | Description |
|---|---|---|
| BG000 | Enzalutamide + Abiraterone + Prednisone | Participants received enzalutamide combined with abiraterone acetate once daily plus prednisone twice daily. |
| 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 |
| ||||||||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
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| Race/Ethnicity, Customized | Count of Participants | Participants |
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| Ethnicity | 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 Adverse Events (AEs) | A treatment-emergent adverse event (TEAE) was defined as an adverse event occurring or worsening between the start of study treatment date and the latest date of 30 days after the last dose date or the 30-day follow-up visit date, and not later than the data cut-off date or the date of death. AEs, including abnormal clinical laboratory values, were graded using the National Cancer Institute-Common Terminology Criteria for Adverse Events (NCI-CTCAE) guidelines (V4.03). | The analysis population consisted of the safety analysis set (SAF) which consisted of all participants who received at least 1 dose of any drug of the study combination treatment (i.e., enzalutamide, abiraterone and prednisone). | Posted | Count of Participants | Participants | From the first dose of study drug administration up 30 days following the last dose of study drug date, with a median duration of treatment of 10.1 months. |
|
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| Secondary | Change From Baseline in Testosterone Concentration in Bone Marrow Aspirate | Testosterone concentration in bone marrow aspirate was measured by laboratory results derived from bone marrow samples processed through liquid chromatography mass spectrometry. | The analysis population consisted of the biomarker testosterone evaluable set (BTES) which consisted of all participants from the SAF with baseline and week 9 testosterone laboratory results derived from bone marrow samples. | Posted | Geometric Mean | Standard Deviation | pmol/L | Baseline and Week 9 |
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| Secondary | Change From Baseline in Dihydrotestosterone (DHT) Concentration in Bone Marrow Aspirate | DHT concentration in bone marrow aspirate was to be measured by laboratory results derived from bone marrow samples processed through liquid chromatography mass spectrometry. DHT bone data were not collected. | DHT bone data were not collected. | Posted | Baseline and Week 9 |
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| Secondary | Change From Baseline in Cortisol in Bone Marrow Aspirate | Cortisol in bone marrow aspirate was measured by laboratory results derived from bone marrow samples. | The analysis population consisted of the biomarker cortisol evaluable set (BCES) which consisted of all participants from the SAF with baseline and week 9 cortisol laboratory results derived from bone marrow samples. | Posted | Geometric Mean | Standard Deviation | nmol/L | Baseline and Week 9 |
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| Secondary | Change From Baseline in Androstenedione in Bone Marrow Aspirate | Androstenedione in bone marrow aspirate was measured by laboratory results derived from bone marrow samples. | The analysis population consisted of the biomarker androstenedione evaluable set (BAOS) which consisted of all participants from the SAF with baseline and week 9 androstenedione laboratory results derived from bone marrow samples. | Posted | Geometric Mean | Standard Deviation | nmol/L | Baseline and Week 9 |
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| Secondary | Change From Baseline in Progesterone in Bone Marrow Aspirate | Progesterone in bone marrow aspirate was measured by laboratory results derived from bone marrow samples. | The analysis population consisted of the biomarker progesterone evaluable set (BOES) which consisted of all participants from the SAF with baseline and week 9 progesterone laboratory results derived from bone marrow samples. | Posted | Geometric Mean | Standard Deviation | nmol/L | Baseline and Week 9 |
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| Secondary | Change From Baseline in Pregnenolone in Bone Marrow Aspirate | Pregnenolone in bone marrow aspirate was measured by laboratory results derived from bone marrow samples. | The analysis population consisted of the biomarker pregnenolone evaluable set (BEES) which consisted of all participants from the SAF with baseline and week 9 pregnenolone laboratory results derived from bone marrow samples. | Posted | Geometric Mean | Standard Deviation | pg/ml | Baseline and Week 9 |
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| Secondary | Change From Baseline in Testosterone Concentration in Blood | Testosterone concentration in blood was measured by laboratory results derived from plasma samples. Plasma samples were derived from collected blood samples processed through liquid chromatography mass spectrometry. | The analysis population consisted of the plasma testosterone evaluable set (PTES) which consisted of all participants from the SAF with baseline and week 9 testosterone laboratory results derived from plasma samples. | Posted | Geometric Mean | Standard Deviation | nmol/L | Baseline and Week 9 |
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| Secondary | Change From Baseline in DHT Concentration in Blood | DHT concentration in blood was measured by laboratory results derived from plasma samples. Plasma samples were derived from collected blood samples processed through liquid chromatography mass spectrometry. The endpoint could not be analyzed since no participants had DHT levels over the lower limit of quantification (LLOQ). | The endpoint could not be analyzed since no participants had DHT levels over the LLOQ. | Posted | Baseline and Week 9 |
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| Secondary | Change From Baseline in Cortisol Concentration in Blood | Cortisol concentration in blood was measured by laboratory results derived from plasma samples. Plasma samples were derived from collected blood samples processed through liquid chromatography mass spectrometry. | The analysis population consisted of the plasma cortisol evaluable set (PCES) which consisted of all participants from the SAF with baseline and week 9 cortisol laboratory results derived from plasma samples. | Posted | Geometric Mean | Standard Deviation | nmol/L | Baseline and Week 9 |
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| Secondary | Change From Baseline in Androstenedione Concentration in Blood | Androstenedione concentration in blood was measured by laboratory results derived from plasma samples. Plasma samples were derived from collected blood samples processed through liquid chromatography mass spectrometry. | The analysis population consisted of the plasma androstenedione evaluable set (PAOS) which consisted of all participants from the SAF with baseline and week 9 androstenedione laboratory results derived from plasma samples. | Posted | Geometric Mean | Standard Deviation | nmol/L | Baseline and Week 9 |
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| Secondary | Change From Baseline in Progesterone Concentration in Blood | Progesterone concentration in blood was measured by laboratory results derived from plasma samples. Plasma samples were derived from collected blood samples processed through liquid chromatography mass spectrometry. | The analysis population consisted of the plasma progesterone evaluable set (POES) which consisted of all participants from the SAF with baseline and week 9 progesterone laboratory results derived from plasma samples. | Posted | Geometric Mean | Standard Deviation | nmol/L | Baseline and Week 9 |
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| Secondary | Change From Baseline in Pregnenolone Concentration in Blood | Pregnenolone concentration in blood was measured by laboratory results derived from plasma samples. Plasma samples were derived from collected blood samples processed through liquid chromatography mass spectrometry. | The analysis population consisted of the plasma pregnenolone evaluable set (PEES) which consisted of all participants from the SAF with baseline and week 9 pregnenolone laboratory results derived from plasma samples. | Posted | Geometric Mean | Standard Deviation | pg/ml | Baseline and Week 9 |
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| Secondary | Change From Baseline to End-of-Treatment (EoT) in Prostate-Specific Antigen (PSA) Levels | Prostate-specific antigen progression by Prostate Cancer Clinical Trials Working Group 2 (PCWG2) was defined as a PSA increase ≥25% and ≥2 ng/ml above the post-baseline nadir, and which was confirmed by the first subsequent value of 3 or more weeks later. | The analysis population consisted of the SAF (participants with available data). | Posted | Geometric Mean | Standard Deviation | ug/L | Baseline and EoT; the median duration of treatment was 10.1 months. |
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| Secondary | Progression Free Survival (PFS) | PFS was measured as the time from the date of first dose of any drug of the study combination treatment until the first evidence of documented progression (a composite endpoint consisting of radiographic progression or PSA progression by PCWG2 or clinical deterioration) or death in the absence of progression (whichever came first) or the date last known to be progression free. The Kaplan-Meier (KM) 95% CI was based on Brookmeyer and Crowley robust non-parametric method. | The analysis population consisted of the SAF. | Posted | Median | 95% Confidence Interval | days | Up to 1849 days |
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| Secondary | Percentage of Participants With Objective Response for Soft Tissue Lesions According to Response Evaluation Criteria in Solid Tumors 1.1 (RECIST) | Objective response was based on RECIST version 1.1 for soft tissue lesion on Magnetic resonance imaging (MRI) / Computerized tomography (CT) and the PCWG2 guidelines for bone lesions on bone scans and was defined as partial response (PR) or complete response (CR) based on the investigators' assessments of target, non-target and new lesions while on study treatment. The 95% for objective response rate was based on exact binomial 95% confidence interval (Clopper-Pearson). | The analysis population consisted of the SAF (participants with measurable soft tissue disease per RECIST 1.1 at baseline with available data). | Posted | Median | 95% Confidence Interval | percentage of participants | Up to 1849 days |
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| Secondary | Bone Scan Response at EoT | PD: ≥1 of 3 criteria: PSA progression: ≥2 rising PSA levels, interval of ≥1 week between each determination. Soft tissue disease progression: RECIST 1.1. Bone disease progression: PCWG2 criteria (≥2 or new lesions on bone scan compared with prior scan). Target lesion CR: disappearance of all target lesions, PR as ≥30% decrease in sum of longest diameter (LD) of target lesions, referencing baseline sum LD, SD: neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, referencing smallest sum LD since treatment start, PD ≥20% increase in sum of LD of target lesions, referencing smallest sum LD recorded since treatment start or appearance of ≥1 new lesions. Non-target lesions CR: disappearance of all non-target lesions and normalization of tumor marker level, SD: persistence of ≥1 non-target lesions and/or maintenance of tumor marker level above normal limits, PD: appearance of ≥1 new lesions and/or unequivocal progression of existing non-target lesions. | The analysis population consisted of the SAF (participants with available data). | Posted | Count of Participants | Participants | EoT; the median duration of treatment was 10.1 months. |
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| Secondary | Change From Baseline to EoT in Bone Specific Alkaline Phosphatase | Bone metabolism marker bone specific alkaline phosphatase levels were derived from blood samples collected. | The analysis population consisted of the SAF (participants with available data). | Posted | Geometric Mean | Standard Deviation | ug/L | Baseline and EoT; the median duration of treatment was 10.1 months. |
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| Secondary | Change From Baseline in Urine N-Telopeptide | Bone metabolism marker urine N-telopeptide levels were derived from urine samples collected. | The analysis population consisted of the SAF (participants with available data). | Posted | Geometric Mean | Standard Deviation | nmolBCE/mmolcreat | Baseline and Week 9 |
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| Other Pre-specified | Androgen Receptor Signaling Assessed by Expression and Localization of Androgen Receptor (AR), CYP17 Expression, Splice Variants, and Pathways Linked With Non-classical AR Signaling and Bone Development | The endpoint was considered exploratory and no analysis was planned. | Data for these endpoints were not collected. | Posted | Baseline and Week 9 |
|
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From the first dose of study drug administration up 30 days following the last dose of study drug date, with a median duration of treatment of 10.1 months.
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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 + Abiraterone + Prednisone | Participants received enzalutamide combined with abiraterone acetate once daily plus prednisone twice daily. | 0 | 60 | 9 | 60 | 60 | 60 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Angina pectoris | Cardiac disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Atrial fibrillation | Cardiac disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Macular oedema | Eye disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Retinal vein occlusion | Eye disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Urosepsis | Infections and infestations | MedDRA 12.0 | Systematic Assessment |
| |
| Femur fracture | Injury, poisoning and procedural complications | MedDRA 12.0 | Systematic Assessment |
| |
| Hip fracture | Injury, poisoning and procedural complications | MedDRA 12.0 | Systematic Assessment |
| |
| Spinal compression fracture | Injury, poisoning and procedural complications | MedDRA 12.0 | Systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Spinal cord compression | Nervous system disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Hypotension | Vascular disorders | MedDRA 12.0 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA 12.0 | Systematic Assessment |
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| Sinus bradycardia | Cardiac disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Vertigo | Ear and labyrinth disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Abdominal pain upper | Gastrointestinal disorders | MedDRA 12.0 | Systematic Assessment |
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| Constipation | Gastrointestinal disorders | MedDRA 12.0 | Systematic Assessment |
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| Diarrhoea | Gastrointestinal disorders | MedDRA 12.0 | Systematic Assessment |
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| Dry mouth | Gastrointestinal disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Asthenia | General disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Fatigue | General disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Influenza like illness | General disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Non-cardiac chest pain | General disorders | MedDRA 12.0 | Systematic Assessment |
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| Oedema peripheral | General disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA 12.0 | Systematic Assessment |
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| Herpes zoster | Infections and infestations | MedDRA 12.0 | Systematic Assessment |
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| Sinusitis | Infections and infestations | MedDRA 12.0 | Systematic Assessment |
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| Fall | Injury, poisoning and procedural complications | MedDRA 12.0 | Systematic Assessment |
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| Joint injury | Injury, poisoning and procedural complications | MedDRA 12.0 | Systematic Assessment |
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| Activated partial thromboplastin time prolonged | Investigations | MedDRA 12.0 | Systematic Assessment |
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| Alanine aminotransferase increased | Investigations | MedDRA 12.0 | Systematic Assessment |
| |
| Aspartate aminotransferase increased | Investigations | MedDRA 12.0 | Systematic Assessment |
| |
| Blood albumin decreased | Investigations | MedDRA 12.0 | Systematic Assessment |
| |
| Blood alkaline phosphatase increased | Investigations | MedDRA 12.0 | Systematic Assessment |
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| Blood bilirubin increased | Investigations | MedDRA 12.0 | Systematic Assessment |
| |
| Blood creatinine increased | Investigations | MedDRA 12.0 | Systematic Assessment |
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| Blood glucose increased | Investigations | MedDRA 12.0 | Systematic Assessment |
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| Blood magnesium decreased | Investigations | MedDRA 12.0 | Systematic Assessment |
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| Blood potassium decreased | Investigations | MedDRA 12.0 | Systematic Assessment |
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| Lymphocyte count decreased | Investigations | MedDRA 12.0 | Systematic Assessment |
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| Neutrophil count decreased | Investigations | MedDRA 12.0 | Systematic Assessment |
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| Platelet count decreased | Investigations | MedDRA 12.0 | Systematic Assessment |
| |
| White blood cell count decreased | Investigations | MedDRA 12.0 | Systematic Assessment |
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| Anorexia | Metabolism and nutrition disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Dehydration | Metabolism and nutrition disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Hypercalcaemia | Metabolism and nutrition disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Hyperglycaemia | Metabolism and nutrition disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Hypernatraemia | Metabolism and nutrition disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Hypoalbuminaemia | Metabolism and nutrition disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Hypocalcaemia | Metabolism and nutrition disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Hypokalaemia | Metabolism and nutrition disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Hypomagnesaemia | Metabolism and nutrition disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Hypophosphataemia | Metabolism and nutrition disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Bone pain | Musculoskeletal and connective tissue disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Muscle spasms | Musculoskeletal and connective tissue disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Musculoskeletal chest pain | Musculoskeletal and connective tissue disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Musculoskeletal pain | Musculoskeletal and connective tissue disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Neck pain | Musculoskeletal and connective tissue disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Balance disorder | Nervous system disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Cognitive disorder | Nervous system disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Dysgeusia | Nervous system disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Memory impairment | Nervous system disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Paraesthesia | Nervous system disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Peripheral sensory neuropathy | Nervous system disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Tremor | Nervous system disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Depression | Psychiatric disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Insomnia | Psychiatric disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Nephrolithiasis | Renal and urinary disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Pollakiuria | Renal and urinary disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Productive cough | Respiratory, thoracic and mediastinal disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Rhinitis allergic | Respiratory, thoracic and mediastinal disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Alopecia | Skin and subcutaneous tissue disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Rash maculo-papular | Skin and subcutaneous tissue disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Hot flush | Vascular disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDRA 12.0 | Systematic Assessment |
|
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 Trial Disclosure | Astellas Pharma Global Development, Inc. (APGD) | 800-888-7704 | astellas.resultsdisclosure@astellas.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Jan 4, 2016 | Dec 13, 2018 | SAP_001.pdf |
| ID | Term |
|---|---|
| D009369 | Neoplasms |
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| C540278 | enzalutamide |
| D000069501 | Abiraterone Acetate |
| D011241 | Prednisone |
| ID | Term |
|---|---|
| D000736 | Androstenes |
| D000731 | Androstanes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D011244 | Pregnadienediols |
| D011245 | Pregnadienes |
| D011278 | Pregnanes |
Not provided
Not provided
| Asian |
|
| Other |
|
| Title | Measurements |
|---|---|
|
| Prednisone-related TEAEs |
|
| Deaths |
|
| Serious TEAEs |
|
| Enzalutamide-related serious TEAEs |
|
| Abiraterone-related serious TEAEs |
|
| Prednisone-related serious TEAEs |
|
| TEAEs leading to discontinuation of enzalutamide |
|
| Enza-related TEAEs leading to disc. of enza |
|
| Abiraterone-related TEAEs leading to disc. of enza |
|
| Prednisone-related TEAEs leading to disc. of enza |
|
| TEAEs leading to discontinuation of abiraterone |
|
| Abiraterone-related TEAEs leading to disc. of abi |
|
|
|
|
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| Participants |
|
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| Title | Denominators | Categories | ||||
|---|---|---|---|---|---|---|
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