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| ID | Type | Description | Link |
|---|---|---|---|
| COU-AA-001 | Other Identifier | Cougar Biotechnology |
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The purpose of this study is to determine the maximum tolerated dose and evaluate the safety, tolerability, and activity at the recommended dose (maximum tolerated dose [MTD]) of abiraterone acetate (also known as CB7630) in participants with hormone refractory prostate (gland that makes fluid that aids movement of sperm) cancer (HRPC).
This is an open-label (all people know the identity of the intervention) study to evaluate the safety, tolerability, and recommended dose of abiraterone acetate taken orally (by mouth), once daily in participants with HRPC. The study will consist of a dose escalation stage (Phase 1) that will be conducted to determine the MTD of abiraterone and an activity evaluation stage (Phase 2) to evaluate the activity of abiraterone in participants with HRPC. Escalated doses of abiraterone (starting at 250 milligram [mg] up to a maximum of 2000 mg) will be given for 28-day treatment periods to determine the MTD. Participants will be given MTD of abiraterone for up to 12 cycles (28 day each) in Phase 2 of the study. Participants' safety will be monitored throughout the study.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Abiraterone acetate | Experimental | Abiraterone acetate 250 mg up to a maximum of 2000 mg capsules will be given orally daily for 28-day treatment period to determine the MTD in Phase 1 of the study. Participants will receive MTD of abiraterone acetate for 12 cycles (28 day each) in Phase 2 of the study. Dexamethasone 0.5 mg will be given orally (If participants have disease progression) daily up to 12 cycles. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Abiraterone acetate | Drug | Abiraterone 250 mg (1 capsule) up to 2000 mg (8 capsules) once daily, each dose will be tested in sequential order for 28 days to determine the MTD. |
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| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Confirmed Prostate Specific Antigen (PSA) Response at Week 12 | The PSA response was measured according to PSA working group (PSAWG) criteria. All participants achieving a fall in PSA of greater than 50 percent from baseline, which has been confirmed by a second measurement at least 4 weeks after initial documentation, fulfill criteria for confirmed PSA response. | Baseline, Week 12 |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Objective Tumor Response | Number of participants with objective response based on assessment of confirmed complete response (CR) or confirmed partial response (PR) according to Response Evaluation Criteria in Solid Tumors (RECIST). Confirmed CR defined as disappearance of all target lesions. Confirmed PR defined as greater than or equal to 30 percent decrease in sum of the longest dimensions (LD) of the target lesions taking as a reference the baseline sum LD according to RECIST. Confirmed responses are those that persist on repeat imaging study greater than or equal to 4 weeks after initial documentation of response. |
| Measure | Description | Time Frame |
|---|---|---|
| Serum Blood Levels of Testosterone | Concentration of testosterone in blood was measured in nanogram per deciliter (ng/dL). | Baseline, Cycle 2 (within 3 days prior to Day 29) |
| Number of Participants With Treatment-Emergent Adverse Events (AEs) or Serious Adverse Events (SAEs) |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Cougar Biotechnology Clinical Trial | Cougar Biotechnology, Inc. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Sutton | United Kingdom |
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| Label | URL |
|---|---|
| NATIONAL CANCER INSTITUTE | View source |
| PROSTATE CANCER | View source |
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| ID | Title | Description |
|---|---|---|
| FG000 | 250 mg/Day | Abiraterone acetate 250 milligram (mg) capsule administered orally daily for 28-day treatment period to determine the maximum tolerated dose (MTD) in Phase 1 of the study. Participants received MTD (1000 mg) of abiraterone acetate for 12 cycles (28 day each) in Phase 2 of the study. Dexamethasone 0.5 mg administered orally (if participants have disease progression) daily up to 12 cycles. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Period 1 (Phase 1) |
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| Abiraterone acetate MTD | Drug | Abiraterone acetate MTD orally for 12 cycles (28 day each). |
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| Dexamethasone | Drug | Dexamethasone 0.5 mg orally will be given (If participants have disease progression) daily up to 12 cycles. |
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| Baseline up to end of study (1160 days) |
| Duration of Prostate Specific Antigen (PSA) Response | Duration of PSA response in participants on abiraterone acetate therapy was measured as the duration between PSA 50 percent decline date and PSA progression date as defined by the PSAWG criteria. | Baseline up to end of study (1160 days) |
| Duration of Objective Tumor Response by Response Evaluation Criteria in Solid Tumors (RECIST) | Number of participants with objective response based on assessment of confirmed CR or confirmed PR according to RECIST. Confirmed CR defined as disappearance of all target lesions. Confirmed PR defined as greater than or equal to 30 percent decrease in sum of the LD of the target lesions taking as a reference the baseline sum LD according to RECIST. Confirmed responses are those that persist on repeat imaging study greater than or equal to 4 weeks after initial documentation of response. | Baseline up to end of study (1160 days) |
| Time to Disease Progression | Disease progression was defined as greater than 25 percent increase in sum of longest diameter of target lesions compared to baseline. | Baseline up to end of study (1160 days) |
| Overall Survival | Overall survival was the duration from enrollment to death. For participants who are alive, overall survival was censored at the last contact. | Baseline up to end of study (1160 days) |
An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent are events between first dose of study drug and up to 28 days after last dose that were absent before treatment or that worsened relative to pretreatment state. |
| Baseline up to 30 days after the last dose of study medication |
| Serum Blood Levels of Testosterone Precursors | Concentration of Cortisol, Aldosterone, Corticosterone, 11-Deoxycortisol, Deoxycorticosterone and Dehydroepiandrostenedione Sulphate (DHEA-S) in blood was measured in nanogram per deciliter (ng/dL). | Baseline, Cycle 2 (within 3 days prior to Day 29) |
| Time to Prostate Cancer Pain Progression | The time from start of study treatment to the development/worsening of pain due to prostate cancer requiring one or more of the following treatments: 1- Opioid therapy (therapy with morphine like medicines for 10 out of 14 consecutive days); 2- Glucocorticoid therapy; 3- Initiation of >= 5 mg of prednisolone for 10 out of 14 consecutive days; 4- Radionuclide therapy; 5- Radiation therapy (x-ray or cobalt treatment); 6- Chemotherapy (treatment of disease by chemical agents). Participants who do not experience prostate cancer pain were censored on their last day on study. Time to prostate cancer pain progression was measured by Kaplan-Meier method. | Baseline up to 12 cycles |
| Number of Participants With Change From Baseline in Biochemical Bone Markers | Baseline, Cycle 2, 4, 8, 12 |
| Mean Plasma Concentration of Abiraterone | Pre-dose on Day 1, 8 and 15 of Cycle 1, Day 1 of Cycle 2, Day 1 of Cycle 3; 1, 2, 4, 6, 8, 24, 48 and 72 hours after first dose was given |
| Maximum Observed Plasma Concentration (Cmax) of Abiraterone | The Cmax is defined as maximum observed analyte concentration. | Pre-dose on Day 1, 8 and 15 of Cycle 1, Day 1 of Cycle 2, Day 1 of Cycle 3; 1, 2, 4, 6, 8, 24, 48 and 72 hours after first dose was given |
| Time to Reach Maximum Observed Plasma Concentration (Tmax) of Abiraterone | The Tmax is defined as actual sampling time to reach maximum observed plasma concentration. The analyte concentration associated with Tmax is referred to as Cmax. | Pre-dose on Day 1, 8 and 15 of Cycle 1, Day 1 of Cycle 2, Day 1 of Cycle 3; 1, 2, 4, 6, 8, 24, 48 and 72 hours after first dose was given |
| Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) of Abiraterone | Area under the plasma concentration time-curve from time zero to the last quantifiable concentration (AUClast). | Pre-dose on Day 1, 8 and 15 of Cycle 1, Day 1 of Cycle 2, Day 1 of Cycle 3; 1, 2, 4, 6, 8, 24, 48 and 72 hours after first dose was given |
| Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0 - ∞)] of Abiraterone | AUC (0 - ∞)= Area under the plasma concentration versus time curve (AUC) from time zero (pre-dose) to extrapolated infinite time (0 - ∞). It is obtained from AUC (0 - t) plus AUC (t - ∞). | Pre-dose on Day 1, 8 and 15 of Cycle 1, Day 1 of Cycle 2, Day 1 of Cycle 3; 1, 2, 4, 6, 8, 24, 48 and 72 hours after first dose was given |
| Plasma Decay Half-Life (t1/2) of Abiraterone | Plasma decay half-life is the time measured for the plasma concentration to decrease by one half. | Pre-dose on Day 1, 8 and 15 of Cycle 1, Day 1 of Cycle 2, Day 1 of Cycle 3; 1, 2, 4, 6, 8, 24, 48 and 72 hours after first dose was given |
| Time to Last Quantifiable Plasma Concentration (Tlast) of Abiraterone | The actual sampling time of last measurable (non-below the limit of quantification [BQL]) analyte concentration. The analyte concentration associated with Tlast is referred to as Clast. | Pre-dose on Day 1, 8 and 15 of Cycle 1, Day 1 of Cycle 2, Day 1 of Cycle 3; 1, 2, 4, 6, 8, 24, 48 and 72 hours after first dose was given |
| FG001 | 500 mg/Day | Abiraterone acetate 500 mg capsules (2 x 250 mg capsules) administered orally daily for 28-day treatment period to determine the MTD in Phase 1 of the study. Participants received MTD of abiraterone acetate for 12 cycles (28 day each) in Phase 2 of the study. Dexamethasone 0.5 mg administered orally (if participants have disease progression) daily up to 12 cycles. |
| FG002 | 750 mg/Day | Abiraterone acetate 750 mg capsules (3 x 250 mg capsules) administered orally daily for 28-day treatment period to determine the MTD in Phase 1 of the study. Participants received MTD of abiraterone acetate for 12 cycles (28 day each) in Phase 2 of the study. Dexamethasone 0.5 mg administered orally (if participants have disease progression) daily up to 12 cycles. |
| FG003 | 1000 mg/Day | Abiraterone acetate 1000 mg capsules (4 x 250 mg capsules) administered orally daily for 28-day treatment period to determine the MTD in Phase 1 of the study. Participants received MTD of abiraterone acetate for 12 cycles (28 day each) in Phase 2 of the study. Dexamethasone 0.5 mg administered orally (if participants have disease progression) daily up to 12 cycles. |
| FG004 | 2000 mg/Day | Abiraterone acetate 2000 mg capsules (8 x 250 mg capsules) administered orally daily for 28-day treatment period to determine the MTD in Phase 1 of the study. Participants received MTD of abiraterone acetate for 12 cycles (28 day each) in Phase 2 of the study. Dexamethasone 0.5 mg administered orally (if participants have disease progression) daily up to 12 cycles. |
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| Period 2 (Phase 2) |
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| ID | Title | Description |
|---|---|---|
| BG000 | 250 mg/Day | Abiraterone acetate 250 mg capsule administered orally daily for 28-day treatment period to determine the MTD in Phase 1 of the study. Participants received MTD of abiraterone acetate for 12 cycles (28 day each) in Phase 2 of the study. Dexamethasone 0.5 mg administered orally (if participants have disease progression) daily up to 12 cycles. |
| BG001 | 500 mg/Day | Abiraterone acetate 500 mg capsules (2 x 250 mg capsules) administered orally daily for 28-day treatment period to determine the MTD in Phase 1 of the study. Participants received MTD of abiraterone acetate for 12 cycles (28 day each) in Phase 2 of the study. Dexamethasone 0.5 mg administered orally (if participants have disease progression) daily up to 12 cycles. |
| BG002 | 750 mg/Day | Abiraterone acetate 750 mg capsules (3 x 250 mg capsules) administered orally daily for 28-day treatment period to determine the MTD in Phase 1 of the study. Participants received MTD of abiraterone acetate for 12 cycles (28 day each) in Phase 2 of the study. Dexamethasone 0.5 mg administered orally (if participants have disease progression) daily up to 12 cycles. |
| BG003 | 1000 mg/Day | Abiraterone acetate 1000 mg capsules (4 x 250 mg capsules) administered orally daily for 28-day treatment period to determine the MTD in Phase 1 of the study. Participants received MTD of abiraterone acetate for 12 cycles (28 day each) in Phase 2 of the study. Dexamethasone 0.5 mg administered orally (if participants have disease progression) daily up to 12 cycles. |
| BG004 | 2000 mg/Day | Abiraterone acetate 2000 mg capsules (8 x 250 mg capsules) administered orally daily for 28-day treatment period to determine the MTD in Phase 1 of the study. Participants received MTD of abiraterone acetate for 12 cycles (28 day each) in Phase 2 of the study. Dexamethasone 0.5 mg administered orally (if participants have disease progression) daily up to 12 cycles. |
| BG005 | Total | Total of all reporting groups |
| Units | Counts |
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| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
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| Age, Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | 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 Confirmed Prostate Specific Antigen (PSA) Response at Week 12 | The PSA response was measured according to PSA working group (PSAWG) criteria. All participants achieving a fall in PSA of greater than 50 percent from baseline, which has been confirmed by a second measurement at least 4 weeks after initial documentation, fulfill criteria for confirmed PSA response. | All participants who were enrolled in the study and received 1000 milligram abiraterone acetate therapy with or without dexamethasone (including participants who received 1000 mg AA monotherapy). Here 'N' (number of participants analyzed) signifies those participants evaluable for this measure. | Posted | Number | Participants | Baseline, Week 12 |
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| Secondary | Number of Participants With Objective Tumor Response | Number of participants with objective response based on assessment of confirmed complete response (CR) or confirmed partial response (PR) according to Response Evaluation Criteria in Solid Tumors (RECIST). Confirmed CR defined as disappearance of all target lesions. Confirmed PR defined as greater than or equal to 30 percent decrease in sum of the longest dimensions (LD) of the target lesions taking as a reference the baseline sum LD according to RECIST. Confirmed responses are those that persist on repeat imaging study greater than or equal to 4 weeks after initial documentation of response. | All participants who were enrolled in the study and received 1000 milligram abiraterone acetate therapy with or without dexamethasone (including participants who received 1000 mg AA monotherapy). Here 'N' (number of participants analyzed) signifies those participants evaluable for this measure. | Posted | Number | Participants | Baseline up to end of study (1160 days) |
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| Secondary | Duration of Prostate Specific Antigen (PSA) Response | Duration of PSA response in participants on abiraterone acetate therapy was measured as the duration between PSA 50 percent decline date and PSA progression date as defined by the PSAWG criteria. | All participants who were enrolled in the study and received 1000 milligram abiraterone acetate therapy with or without dexamethasone (including participants who received 1000 mg AA monotherapy). Here 'N' (number of participants analyzed) signifies those participants evaluable for this measure. | Posted | Median | Full Range | Days | Baseline up to end of study (1160 days) |
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| Secondary | Duration of Objective Tumor Response by Response Evaluation Criteria in Solid Tumors (RECIST) | Number of participants with objective response based on assessment of confirmed CR or confirmed PR according to RECIST. Confirmed CR defined as disappearance of all target lesions. Confirmed PR defined as greater than or equal to 30 percent decrease in sum of the LD of the target lesions taking as a reference the baseline sum LD according to RECIST. Confirmed responses are those that persist on repeat imaging study greater than or equal to 4 weeks after initial documentation of response. | Duration of response was not analyzed as majority of participants with objective tumor response were lost to follow-up. | Posted | Baseline up to end of study (1160 days) |
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| Secondary | Time to Disease Progression | Disease progression was defined as greater than 25 percent increase in sum of longest diameter of target lesions compared to baseline. | Data was not analyzed because at the time to progression, participants also received dexamethasone treatment, making it impractical to accurately define disease progression. | Posted | Baseline up to end of study (1160 days) |
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| Secondary | Overall Survival | Overall survival was the duration from enrollment to death. For participants who are alive, overall survival was censored at the last contact. | Data was not analyzed due to high number of participants censored for survival. | Posted | Baseline up to end of study (1160 days) |
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| Other Pre-specified | Serum Blood Levels of Testosterone | Concentration of testosterone in blood was measured in nanogram per deciliter (ng/dL). | All participants who were enrolled in the study and received 1000 mg abiraterone acetate therapy with or without dexamethasone (including participants who received 1000 mg AA monotherapy). Here 'N' (number of participants analyzed) signifies participants evaluable for this measure and 'n' signifies participants evaluable at specified time point. | Posted | Median | Full Range | ng/dL | Baseline, Cycle 2 (within 3 days prior to Day 29) |
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| Other Pre-specified | Number of Participants With Treatment-Emergent Adverse Events (AEs) or Serious Adverse Events (SAEs) | An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent are events between first dose of study drug and up to 28 days after last dose that were absent before treatment or that worsened relative to pretreatment state. | Included all participants who received any amount of the study medication. | Posted | Number | participants | Baseline up to 30 days after the last dose of study medication |
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| Other Pre-specified | Serum Blood Levels of Testosterone Precursors | Concentration of Cortisol, Aldosterone, Corticosterone, 11-Deoxycortisol, Deoxycorticosterone and Dehydroepiandrostenedione Sulphate (DHEA-S) in blood was measured in nanogram per deciliter (ng/dL). | All participants who were enrolled in the study and received 1000 mg abiraterone acetate therapy with or without dexamethasone (including participants who received 1000 mg AA monotherapy). Here 'N' (number of participants analyzed) signifies participants evaluable for this measure and 'n' signifies participants evaluable at specified time point. | Posted | Median | Full Range | ng/dL | Baseline, Cycle 2 (within 3 days prior to Day 29) |
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| Other Pre-specified | Time to Prostate Cancer Pain Progression | The time from start of study treatment to the development/worsening of pain due to prostate cancer requiring one or more of the following treatments: 1- Opioid therapy (therapy with morphine like medicines for 10 out of 14 consecutive days); 2- Glucocorticoid therapy; 3- Initiation of >= 5 mg of prednisolone for 10 out of 14 consecutive days; 4- Radionuclide therapy; 5- Radiation therapy (x-ray or cobalt treatment); 6- Chemotherapy (treatment of disease by chemical agents). Participants who do not experience prostate cancer pain were censored on their last day on study. Time to prostate cancer pain progression was measured by Kaplan-Meier method. | Median time was not reached as data was not matured at the time of the analysis, hence no data could be reported. | Posted | Baseline up to 12 cycles |
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| Other Pre-specified | Number of Participants With Change From Baseline in Biochemical Bone Markers | Data was reported in individual participant listings but not summarized due to statistical constraints. | Posted | Baseline, Cycle 2, 4, 8, 12 |
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| Other Pre-specified | Mean Plasma Concentration of Abiraterone | Data was not statistically summarized but reported in individual participant listing as per planned analysis. | Posted | Pre-dose on Day 1, 8 and 15 of Cycle 1, Day 1 of Cycle 2, Day 1 of Cycle 3; 1, 2, 4, 6, 8, 24, 48 and 72 hours after first dose was given |
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| Other Pre-specified | Maximum Observed Plasma Concentration (Cmax) of Abiraterone | The Cmax is defined as maximum observed analyte concentration. | Included all participants who enrolled into the study regardless of the amount of the trial medication received. Here 'N' (number of participants analyzed) signifies those participants evaluable for this measure. | Posted | Mean | Standard Deviation | nmol/L | Pre-dose on Day 1, 8 and 15 of Cycle 1, Day 1 of Cycle 2, Day 1 of Cycle 3; 1, 2, 4, 6, 8, 24, 48 and 72 hours after first dose was given |
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| Other Pre-specified | Time to Reach Maximum Observed Plasma Concentration (Tmax) of Abiraterone | The Tmax is defined as actual sampling time to reach maximum observed plasma concentration. The analyte concentration associated with Tmax is referred to as Cmax. | Included all participants who enrolled into the study regardless of the amount of the trial medication received. Here 'N' (number of participants analyzed) signifies those participants evaluable for this measure. | Posted | Mean | Standard Deviation | hours | Pre-dose on Day 1, 8 and 15 of Cycle 1, Day 1 of Cycle 2, Day 1 of Cycle 3; 1, 2, 4, 6, 8, 24, 48 and 72 hours after first dose was given |
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| Other Pre-specified | Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) of Abiraterone | Area under the plasma concentration time-curve from time zero to the last quantifiable concentration (AUClast). | Included all participants who enrolled into the study regardless of the amount of the trial medication received. Here 'N' (number of participants analyzed) signifies those participants evaluable for this measure. | Posted | Mean | Standard Deviation | hours*nmol/L | Pre-dose on Day 1, 8 and 15 of Cycle 1, Day 1 of Cycle 2, Day 1 of Cycle 3; 1, 2, 4, 6, 8, 24, 48 and 72 hours after first dose was given |
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| Other Pre-specified | Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0 - ∞)] of Abiraterone | AUC (0 - ∞)= Area under the plasma concentration versus time curve (AUC) from time zero (pre-dose) to extrapolated infinite time (0 - ∞). It is obtained from AUC (0 - t) plus AUC (t - ∞). | Included all participants who enrolled into the study regardless of the amount of the trial medication received. Here 'N' (number of participants analyzed) signifies those participants evaluable for this measure. | Posted | Mean | Standard Deviation | hours*nmol/L | Pre-dose on Day 1, 8 and 15 of Cycle 1, Day 1 of Cycle 2, Day 1 of Cycle 3; 1, 2, 4, 6, 8, 24, 48 and 72 hours after first dose was given |
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| Other Pre-specified | Plasma Decay Half-Life (t1/2) of Abiraterone | Plasma decay half-life is the time measured for the plasma concentration to decrease by one half. | Included all participants who enrolled into the study regardless of the amount of the trial medication received. Here 'N' (number of participants analyzed) signifies those participants evaluable for this measure. | Posted | Mean | Standard Deviation | hour | Pre-dose on Day 1, 8 and 15 of Cycle 1, Day 1 of Cycle 2, Day 1 of Cycle 3; 1, 2, 4, 6, 8, 24, 48 and 72 hours after first dose was given |
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| Other Pre-specified | Time to Last Quantifiable Plasma Concentration (Tlast) of Abiraterone | The actual sampling time of last measurable (non-below the limit of quantification [BQL]) analyte concentration. The analyte concentration associated with Tlast is referred to as Clast. | Data was not statistically summarized but reported in individual participant listing as per planned analysis. | Posted | Pre-dose on Day 1, 8 and 15 of Cycle 1, Day 1 of Cycle 2, Day 1 of Cycle 3; 1, 2, 4, 6, 8, 24, 48 and 72 hours after first dose was given |
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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 | 250 mg/Day | Abiraterone acetate 250 mg capsule administered orally daily for 28-day treatment period to determine the MTD in Phase 1 of the study. Participants received MTD of abiraterone acetate for 12 cycles (28 day each) in Phase 2 of the study. Dexamethasone 0.5 mg administered orally (if participants have disease progression) daily up to 12 cycles. | 2 | 3 | 3 | 3 | ||
| EG001 | 500 mg/Day | Abiraterone acetate 500 mg capsules (2 x 250 mg capsules) administered orally daily for 28-day treatment period to determine the MTD in Phase 1 of the study. Participants received MTD of abiraterone acetate for 12 cycles (28 day each) in Phase 2 of the study. Dexamethasone 0.5 mg administered orally (if participants have disease progression) daily up to 12 cycles. | 2 | 3 | 3 | 3 | ||
| EG002 | 750 mg/Day | Abiraterone acetate 750 mg capsules (3 x 250 mg capsules) administered orally daily for 28-day treatment period to determine the MTD in Phase 1 of the study. Participants received MTD of abiraterone acetate for 12 cycles (28 day each) in Phase 2 of the study. Dexamethasone 0.5 mg administered orally (if participants have disease progression) daily up to 12 cycles. | 0 | 3 | 3 | 3 | ||
| EG003 | 1000 mg/Day | Abiraterone acetate 1000 mg capsules (4 x 250 mg capsules) administered orally daily for 28-day treatment period to determine the MTD in Phase 1 of the study. Participants received MTD of abiraterone acetate for 12 cycles (28 day each) in Phase 2 of the study. Dexamethasone 0.5 mg administered orally (if participants have disease progression) daily up to 12 cycles. | 20 | 42 | 41 | 42 | ||
| EG004 | 2000 mg/Day | Abiraterone acetate 2000 mg capsules (8 x 250 mg capsules) administered orally daily for 28-day treatment period to determine the MTD in Phase 1 of the study. Participants received MTD of abiraterone acetate for 12 cycles (28 day each) in Phase 2 of the study. Dexamethasone 0.5 mg administered orally (if participants have disease progression) daily up to 12 cycles. | 2 | 3 | 3 | 3 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Eosinophilia | Blood and lymphatic system disorders | MedDRA Version 11.0 | Non-systematic Assessment |
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| Myocardial infarction | Cardiac disorders | MedDRA Version 11.0 | Non-systematic Assessment |
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| Palpitations | Cardiac disorders | MedDRA Version 11.0 | Non-systematic Assessment |
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| Vomiting | Gastrointestinal disorders | MedDRA Version 11.0 | Non-systematic Assessment |
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| Oedema peripheral | General disorders | MedDRA Version 11.0 | Non-systematic Assessment |
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| Pain | General disorders | MedDRA Version 11.0 | Non-systematic Assessment |
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| Pyrexia | General disorders | MedDRA Version 11.0 | Non-systematic Assessment |
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| Cellulitis | Infections and infestations | MedDRA Version 11.0 | Non-systematic Assessment |
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| Infection | Infections and infestations | MedDRA Version 11.0 | Non-systematic Assessment |
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| Infective exacerbation of chronic obstructive airways disease | Infections and infestations | MedDRA Version 11.0 | Non-systematic Assessment |
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| Lower respiratory tract infection | Infections and infestations | MedDRA Version 11.0 | Non-systematic Assessment |
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| Lyme disease | Infections and infestations | MedDRA Version 11.0 | Non-systematic Assessment |
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| Pneumonia | Infections and infestations | MedDRA Version 11.0 | Non-systematic Assessment |
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| Postoperative wound infection | Infections and infestations | MedDRA Version 11.0 | Non-systematic Assessment |
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| Sepsis | Infections and infestations | MedDRA Version 11.0 | Non-systematic Assessment |
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| Urinary tract infection | Infections and infestations | MedDRA Version 11.0 | Non-systematic Assessment |
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| Drug toxicity | Injury, poisoning and procedural complications | MedDRA Version 11.0 | Non-systematic Assessment |
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| Fall | Injury, poisoning and procedural complications | MedDRA Version 11.0 | Non-systematic Assessment |
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| Femur fracture | Injury, poisoning and procedural complications | MedDRA Version 11.0 | Non-systematic Assessment |
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| Alanine aminotransferase increased | Investigations | MedDRA Version 11.0 | Non-systematic Assessment |
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| Aspartate aminotransferase increased | Investigations | MedDRA Version 11.0 | Non-systematic Assessment |
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| Dehydration | Metabolism and nutrition disorders | MedDRA Version 11.0 | Non-systematic Assessment |
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| Fluid retention | Metabolism and nutrition disorders | MedDRA Version 11.0 | Non-systematic Assessment |
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| Hypokalaemia | Metabolism and nutrition disorders | MedDRA Version 11.0 | Non-systematic Assessment |
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| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA Version 11.0 | Non-systematic Assessment |
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| Bone pain | Musculoskeletal and connective tissue disorders | MedDRA Version 11.0 | Non-systematic Assessment |
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| Mobility decreased | Musculoskeletal and connective tissue disorders | MedDRA Version 11.0 | Non-systematic Assessment |
| |
| Pathological fracture | Musculoskeletal and connective tissue disorders | MedDRA Version 11.0 | Non-systematic Assessment |
| |
| Colon cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA Version 11.0 | Non-systematic Assessment |
| |
| Metastases to liver | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA Version 11.0 | Non-systematic Assessment |
| |
| Metastatic pain | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA Version 11.0 | Non-systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA Version 11.0 | Non-systematic Assessment |
| |
| Migraine | Nervous system disorders | MedDRA Version 11.0 | Non-systematic Assessment |
| |
| Spinal cord compression | Nervous system disorders | MedDRA Version 11.0 | Non-systematic Assessment |
| |
| Confusional state | Psychiatric disorders | MedDRA Version 11.0 | Non-systematic Assessment |
| |
| Renal failure | Renal and urinary disorders | MedDRA Version 11.0 | Non-systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA Version 11.0 | Non-systematic Assessment |
| |
| Pulmonary embolism | Respiratory, thoracic and mediastinal disorders | MedDRA Version 11.0 | Non-systematic Assessment |
| |
| Hypotension | Vascular disorders | MedDRA Version 11.0 | Non-systematic Assessment |
| |
| Vasculitis | Vascular disorders | MedDRA Version 11.0 | Non-systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA Version 11.0 | Non-systematic Assessment |
| |
| Neutropenia | Blood and lymphatic system disorders | MedDRA Version 11.0 | Non-systematic Assessment |
| |
| Atrial fibrillation | Cardiac disorders | MedDRA Version 11.0 | Non-systematic Assessment |
| |
| Bundle branch block right | Cardiac disorders | MedDRA Version 11.0 | Non-systematic Assessment |
| |
| Tinnitus | Ear and labyrinth disorders | MedDRA Version 11.0 | Non-systematic Assessment |
| |
| Eye inflammation | Eye disorders | MedDRA Version 11.0 | Non-systematic Assessment |
| |
| Ocular hyperaemia | Eye disorders | MedDRA Version 11.0 | Non-systematic Assessment |
| |
| Abdominal pain upper | Gastrointestinal disorders | MedDRA Version 11.0 | Non-systematic Assessment |
| |
| Anal fissure | Gastrointestinal disorders | MedDRA Version 11.0 | Non-systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA Version 11.0 | Non-systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA Version 11.0 | Non-systematic Assessment |
| |
| Dry mouth | Gastrointestinal disorders | MedDRA Version 11.0 | Non-systematic Assessment |
| |
| Dyspepsia | Gastrointestinal disorders | MedDRA Version 11.0 | Non-systematic Assessment |
| |
| Flatulence | Gastrointestinal disorders | MedDRA Version 11.0 | Non-systematic Assessment |
| |
| Gastrooesophageal reflux disease | Gastrointestinal disorders | MedDRA Version 11.0 | Non-systematic Assessment |
| |
| Mouth ulceration | Gastrointestinal disorders | MedDRA Version 11.0 | Non-systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA Version 11.0 | Non-systematic Assessment |
| |
| Proctalgia | Gastrointestinal disorders | MedDRA Version 11.0 | Non-systematic Assessment |
| |
| Rectal haemorrhage | Gastrointestinal disorders | MedDRA Version 11.0 | Non-systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA Version 11.0 | Non-systematic Assessment |
| |
| Chest discomfort | General disorders | MedDRA Version 11.0 | Non-systematic Assessment |
| |
| Facial pain | General disorders | MedDRA Version 11.0 | Non-systematic Assessment |
| |
| Fatigue | General disorders | MedDRA Version 11.0 | Non-systematic Assessment |
| |
| Feeling cold | General disorders | MedDRA Version 11.0 | Non-systematic Assessment |
| |
| Inflammation | General disorders | MedDRA Version 11.0 | Non-systematic Assessment |
| |
| Influenza like illness | General disorders | MedDRA Version 11.0 | Non-systematic Assessment |
| |
| Injection site discolouration | General disorders | MedDRA Version 11.0 | Non-systematic Assessment |
| |
| Oedema peripheral | General disorders | MedDRA Version 11.0 | Non-systematic Assessment |
| |
| Pitting oedema | General disorders | MedDRA Version 11.0 | Non-systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA Version 11.0 | Non-systematic Assessment |
| |
| Hepatomegaly | Hepatobiliary disorders | MedDRA Version 11.0 | Non-systematic Assessment |
| |
| Cellulitis | Infections and infestations | MedDRA Version 11.0 | Non-systematic Assessment |
| |
| Fungal infection | Infections and infestations | MedDRA Version 11.0 | Non-systematic Assessment |
| |
| Gastroenteritis | Infections and infestations | MedDRA Version 11.0 | Non-systematic Assessment |
| |
| Gingival infection | Infections and infestations | MedDRA Version 11.0 | Non-systematic Assessment |
| |
| Groin abscess | Infections and infestations | MedDRA Version 11.0 | Non-systematic Assessment |
| |
| Herpes zoster | Infections and infestations | MedDRA Version 11.0 | Non-systematic Assessment |
| |
| Lower respiratory tract infection | Infections and infestations | MedDRA Version 11.0 | Non-systematic Assessment |
| |
| Nasopharyngitis | Infections and infestations | MedDRA Version 11.0 | Non-systematic Assessment |
| |
| Respiratory tract infection viral | Infections and infestations | MedDRA Version 11.0 | Non-systematic Assessment |
| |
| Rhinitis | Infections and infestations | MedDRA Version 11.0 | Non-systematic Assessment |
| |
| Tooth infection | Infections and infestations | MedDRA Version 11.0 | Non-systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | MedDRA Version 11.0 | Non-systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA Version 11.0 | Non-systematic Assessment |
| |
| Contusion | Injury, poisoning and procedural complications | MedDRA Version 11.0 | Non-systematic Assessment |
| |
| Fall | Injury, poisoning and procedural complications | MedDRA Version 11.0 | Non-systematic Assessment |
| |
| Humerus fracture | Injury, poisoning and procedural complications | MedDRA Version 11.0 | Non-systematic Assessment |
| |
| Limb injury | Injury, poisoning and procedural complications | MedDRA Version 11.0 | Non-systematic Assessment |
| |
| Radius fracture | Injury, poisoning and procedural complications | MedDRA Version 11.0 | Non-systematic Assessment |
| |
| Alanine aminotransferase increased | Investigations | MedDRA Version 11.0 | Non-systematic Assessment |
| |
| Aspartate aminotransferase increased | Investigations | MedDRA Version 11.0 | Non-systematic Assessment |
| |
| Blood acid phosphatase increased | Investigations | MedDRA Version 11.0 | Non-systematic Assessment |
| |
| Blood albumin decreased | Investigations | MedDRA Version 11.0 | Non-systematic Assessment |
| |
| Blood alkaline phosphatase decreased | Investigations | MedDRA Version 11.0 | Non-systematic Assessment |
| |
| Blood alkaline phosphatase increased | Investigations | MedDRA Version 11.0 | Non-systematic Assessment |
| |
| Blood creatine increased | Investigations | MedDRA Version 11.0 | Non-systematic Assessment |
| |
| Blood creatinine increased | Investigations | MedDRA Version 11.0 | Non-systematic Assessment |
| |
| Blood lactate dehydrogenase increased | Investigations | MedDRA Version 11.0 | Non-systematic Assessment |
| |
| C-reactive protein increased | Investigations | MedDRA Version 11.0 | Non-systematic Assessment |
| |
| International normalised ratio increased | Investigations | MedDRA Version 11.0 | Non-systematic Assessment |
| |
| Protein total decreased | Investigations | MedDRA Version 11.0 | Non-systematic Assessment |
| |
| Weight decreased | Investigations | MedDRA Version 11.0 | Non-systematic Assessment |
| |
| Weight increased | Investigations | MedDRA Version 11.0 | Non-systematic Assessment |
| |
| Anorexia | Metabolism and nutrition disorders | MedDRA Version 11.0 | Non-systematic Assessment |
| |
| Hyperglycaemia | Metabolism and nutrition disorders | MedDRA Version 11.0 | Non-systematic Assessment |
| |
| Hypokalaemia | Metabolism and nutrition disorders | MedDRA Version 11.0 | Non-systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA Version 11.0 | Non-systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA Version 11.0 | Non-systematic Assessment |
| |
| Bone pain | Musculoskeletal and connective tissue disorders | MedDRA Version 11.0 | Non-systematic Assessment |
| |
| Groin pain | Musculoskeletal and connective tissue disorders | MedDRA Version 11.0 | Non-systematic Assessment |
| |
| Muscle spasms | Musculoskeletal and connective tissue disorders | MedDRA Version 11.0 | Non-systematic Assessment |
| |
| Muscular weakness | Musculoskeletal and connective tissue disorders | MedDRA Version 11.0 | Non-systematic Assessment |
| |
| Musculoskeletal chest pain | Musculoskeletal and connective tissue disorders | MedDRA Version 11.0 | Non-systematic Assessment |
| |
| Musculoskeletal discomfort | Musculoskeletal and connective tissue disorders | MedDRA Version 11.0 | Non-systematic Assessment |
| |
| Musculoskeletal pain | Musculoskeletal and connective tissue disorders | MedDRA Version 11.0 | Non-systematic Assessment |
| |
| Musculoskeletal stiffness | Musculoskeletal and connective tissue disorders | MedDRA Version 11.0 | Non-systematic Assessment |
| |
| Neck pain | Musculoskeletal and connective tissue disorders | MedDRA Version 11.0 | Non-systematic Assessment |
| |
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA Version 11.0 | Non-systematic Assessment |
| |
| Balance disorder | Nervous system disorders | MedDRA Version 11.0 | Non-systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA Version 11.0 | Non-systematic Assessment |
| |
| Dysgeusia | Nervous system disorders | MedDRA Version 11.0 | Non-systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA Version 11.0 | Non-systematic Assessment |
| |
| Hypoaesthesia | Nervous system disorders | MedDRA Version 11.0 | Non-systematic Assessment |
| |
| Lethargy | Nervous system disorders | MedDRA Version 11.0 | Non-systematic Assessment |
| |
| Paraesthesia | Nervous system disorders | MedDRA Version 11.0 | Non-systematic Assessment |
| |
| Parosmia | Nervous system disorders | MedDRA Version 11.0 | Non-systematic Assessment |
| |
| Peripheral sensory neuropathy | Nervous system disorders | MedDRA Version 11.0 | Non-systematic Assessment |
| |
| Anxiety | Psychiatric disorders | MedDRA Version 11.0 | Non-systematic Assessment |
| |
| Depressed mood | Psychiatric disorders | MedDRA Version 11.0 | Non-systematic Assessment |
| |
| Insomnia | Psychiatric disorders | MedDRA Version 11.0 | Non-systematic Assessment |
| |
| Bladder spasm | Renal and urinary disorders | MedDRA Version 11.0 | Non-systematic Assessment |
| |
| Haematuria | Renal and urinary disorders | MedDRA Version 11.0 | Non-systematic Assessment |
| |
| Nocturia | Renal and urinary disorders | MedDRA Version 11.0 | Non-systematic Assessment |
| |
| Pyuria | Renal and urinary disorders | MedDRA Version 11.0 | Non-systematic Assessment |
| |
| Urinary incontinence | Renal and urinary disorders | MedDRA Version 11.0 | Non-systematic Assessment |
| |
| Urinary retention | Renal and urinary disorders | MedDRA Version 11.0 | Non-systematic Assessment |
| |
| Pelvic pain | Reproductive system and breast disorders | MedDRA Version 11.0 | Non-systematic Assessment |
| |
| Testicular atrophy | Reproductive system and breast disorders | MedDRA Version 11.0 | Non-systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA Version 11.0 | Non-systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA Version 11.0 | Non-systematic Assessment |
| |
| Dyspnoea exertional | Respiratory, thoracic and mediastinal disorders | MedDRA Version 11.0 | Non-systematic Assessment |
| |
| Epistaxis | Respiratory, thoracic and mediastinal disorders | MedDRA Version 11.0 | Non-systematic Assessment |
| |
| Pharyngolaryngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA Version 11.0 | Non-systematic Assessment |
| |
| Productive cough | Respiratory, thoracic and mediastinal disorders | MedDRA Version 11.0 | Non-systematic Assessment |
| |
| Wheezing | Respiratory, thoracic and mediastinal disorders | MedDRA Version 11.0 | Non-systematic Assessment |
| |
| Dry skin | Skin and subcutaneous tissue disorders | MedDRA Version 11.0 | Non-systematic Assessment |
| |
| Photosensitivity reaction | Skin and subcutaneous tissue disorders | MedDRA Version 11.0 | Non-systematic Assessment |
| |
| Psoriasis | Skin and subcutaneous tissue disorders | MedDRA Version 11.0 | Non-systematic Assessment |
| |
| Rash | Skin and subcutaneous tissue disorders | MedDRA Version 11.0 | Non-systematic Assessment |
| |
| Rash maculo-papular | Skin and subcutaneous tissue disorders | MedDRA Version 11.0 | Non-systematic Assessment |
| |
| Scab | Skin and subcutaneous tissue disorders | MedDRA Version 11.0 | Non-systematic Assessment |
| |
| Skin atrophy | Skin and subcutaneous tissue disorders | MedDRA Version 11.0 | Non-systematic Assessment |
| |
| Skin disorder | Skin and subcutaneous tissue disorders | MedDRA Version 11.0 | Non-systematic Assessment |
| |
| Skin lesion | Skin and subcutaneous tissue disorders | MedDRA Version 11.0 | Non-systematic Assessment |
| |
| Flushing | Vascular disorders | MedDRA Version 11.0 | Non-systematic Assessment |
| |
| Hot flush | Vascular disorders | MedDRA Version 11.0 | Non-systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDRA Version 11.0 | Non-systematic Assessment |
|
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Senior Director, Clinical Research | Janssen R & D | (310) 943-8040 | 2917 |
| ID | Term |
|---|---|
| D011471 | Prostatic Neoplasms |
| ID | Term |
|---|---|
| D005834 | Genital Neoplasms, Male |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D005832 | Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D011469 | Prostatic Diseases |
| D052801 | Male Urogenital Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D000069501 | Abiraterone Acetate |
| D003907 | Dexamethasone |
| ID | Term |
|---|---|
| D000736 | Androstenes |
| D000731 | Androstanes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D011246 | Pregnadienetriols |
| D011245 | Pregnadienes |
| D011278 | Pregnanes |
| D013259 | Steroids, Fluorinated |
Not provided
Not provided
| Death |
|
| Disease Progression |
|
| Symptomatic Deterioration |
|
| Other |
|
| Male |
|
|
|
|
| OG002 | 750 mg/Day | Abiraterone acetate 750 mg capsules (3 x 250 mg capsules) administered orally daily for 28-day treatment period to determine the MTD in Phase 1 of the study. Participants received MTD of abiraterone acetate for 12 cycles (28 day each) in Phase 2 of the study. Dexamethasone 0.5 mg administered orally (if participants have disease progression) daily up to 12 cycles. |
| OG003 | 1000 mg/Day | Abiraterone acetate 1000 mg capsules (4 x 250 mg capsules) administered orally daily for 28-day treatment period to determine the MTD in Phase 1 of the study. Participants received MTD of abiraterone acetate for 12 cycles (28 day each) in Phase 2 of the study. Dexamethasone 0.5 mg administered orally (if participants have disease progression) daily up to 12 cycles. |
| OG004 | 2000 mg/Day | Abiraterone acetate 2000 mg capsules (8 x 250 mg capsules) administered orally daily for 28-day treatment period to determine the MTD in Phase 1 of the study. Participants received MTD of abiraterone acetate for 12 cycles (28 day each) in Phase 2 of the study. Dexamethasone 0.5 mg administered orally (if participants have disease progression) daily up to 12 cycles. |
|
|
|
| OG004 | Abiraterone Acetate 2000 mg | Abiraterone acetate 2000 mg capsules (8 x 250 mg capsules) given orally daily for 28-day treatment period to determine the maximum tolerated dose (MTD) in Phase 1 of the study. |
|
| OG003 | Abiraterone Acetate 1000 mg | Abiraterone acetate 1000 mg capsules (4 x 250 mg capsules) orally daily given for 28-day treatment period to determine the maximum tolerated dose (MTD) in Phase 1 of the study. |
| OG004 | Abiraterone Acetate 2000 mg | Abiraterone acetate 2000 mg capsules (8 x 250 mg capsules) given orally daily for 28-day treatment period to determine the maximum tolerated dose (MTD) in Phase 1 of the study. |
|
|
| OG003 | Abiraterone Acetate 1000 mg | Abiraterone acetate 1000 mg capsules (4 x 250 mg capsules) orally daily given for 28-day treatment period to determine the maximum tolerated dose (MTD) in Phase 1 of the study. |
| OG004 | Abiraterone Acetate 2000 mg | Abiraterone acetate 2000 mg capsules (8 x 250 mg capsules) given orally daily for 28-day treatment period to determine the maximum tolerated dose (MTD) in Phase 1 of the study. |
|
|
| OG003 | Abiraterone Acetate 1000 mg | Abiraterone acetate 1000 mg capsules (4 x 250 mg capsules) orally daily given for 28-day treatment period to determine the maximum tolerated dose (MTD) in Phase 1 of the study. |
| OG004 | Abiraterone Acetate 2000 mg | Abiraterone acetate 2000 mg capsules (8 x 250 mg capsules) given orally daily for 28-day treatment period to determine the maximum tolerated dose (MTD) in Phase 1 of the study. |
|
|
| OG003 | Abiraterone Acetate 1000 mg | Abiraterone acetate 1000 mg capsules (4 x 250 mg capsules) orally daily given for 28-day treatment period to determine the maximum tolerated dose (MTD) in Phase 1 of the study. |
| OG004 | Abiraterone Acetate 2000 mg | Abiraterone acetate 2000 mg capsules (8 x 250 mg capsules) given orally daily for 28-day treatment period to determine the maximum tolerated dose (MTD) in Phase 1 of the study. |
|
|
| OG003 | Abiraterone Acetate 1000 mg | Abiraterone acetate 1000 mg capsules (4 x 250 mg capsules) orally daily given for 28-day treatment period to determine the maximum tolerated dose (MTD) in Phase 1 of the study. |
| OG004 | Abiraterone Acetate 2000 mg | Abiraterone acetate 2000 mg capsules (8 x 250 mg capsules) given orally daily for 28-day treatment period to determine the maximum tolerated dose (MTD) in Phase 1 of the study. |
|
|
| OG003 | Abiraterone Acetate 1000 mg | Abiraterone acetate 1000 mg capsules (4 x 250 mg capsules) orally daily given for 28-day treatment period to determine the maximum tolerated dose (MTD) in Phase 1 of the study. |
| OG004 | Abiraterone Acetate 2000 mg | Abiraterone acetate 2000 mg capsules (8 x 250 mg capsules) given orally daily for 28-day treatment period to determine the maximum tolerated dose (MTD) in Phase 1 of the study. |
|