Neoplasms

Urinary Tract, Sexual Organs, and Pregnancy Conditions

All Conditions

Prostatic Neoplasms

Genital Neoplasms, Male

Urogenital Neoplasms

Genital Diseases

Genital Diseases, Male

Urogenital Diseases

Prostatic Diseases

Male Urogenital Diseases

Anti-Inflammatory Agents

Antineoplastic Agents

Antiemetics

Gastrointestinal Agents

All Drugs and Chemicals

Dexamethasone

Hormones

Abiraterone Acetate

Dexamethasone acetate

Glucocorticoids

Hormone Antagonists

Antineoplastic Agents, Hormonal

Enzyme Inhibitors

Cytochrome P-450 Enzyme Inhibitors

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.

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.

Abiraterone acetate

Abiraterone acetate MTD orally for 12 cycles (28 day each).

Abiraterone acetate MTD

Dexamethasone 0.5 mg orally will be given (If participants have disease progression) daily up to 12 cycles.

Cougar Biotechnology Clinical Trial

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.

A Safety and Efficacy Study of Abiraterone Acetate in Participants With Prostate Cancer Who Have Failed Hormone Therapy

A Phase I/II Open Label Study of the 17α-Hydroxylase/ C17,20 Lyase Inhibitor, Abiraterone Acetate in Patients With Prostate Cancer Who Have Failed Hormone Therapy

Concentration of testosterone in blood was measured in nanogram per deciliter (ng/dL).

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.

Concentration of Cortisol, Aldosterone, Corticosterone, 11-Deoxycortisol, Deoxycorticosterone and Dehydroepiandrostenedione Sulphate (DHEA-S) in blood was measured in nanogram per deciliter (ng/dL).

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.

The Cmax is defined as maximum observed analyte concentration.

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.

Area under the plasma concentration time-curve from time zero to the last quantifiable concentration (AUClast).

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 - ∞).

Plasma decay half-life is the time measured for the plasma concentration to decrease by one half.

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.

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.

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.

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.

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.

Disease progression was defined as greater than 25 percent increase in sum of longest diameter of target lesions compared to baseline.

Overall survival was the duration from enrollment to death. For participants who are alive, overall survival was censored at the last contact.

Cougar Biotechnology, Inc.

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.

250 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.

500 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.

750 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.

1000 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.

2000 mg/Day

Total

Age, Continuous

Sex: Female, Male

Senior Director, Clinical Research

Participants received 1000 milligram (mg) abiraterone acetate (AA) without dexamethasone.

1000 mg AA Monotherapy

Participants received 1000 mg abiraterone acetate with or without dexamethasone.

1000 mg AA Therapy

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.

Number of Participants With Confirmed Prostate Specific Antigen (PSA) Response at Week 12

Complete response

Partial response

Number of Participants With Objective Tumor Response

Duration of Prostate Specific Antigen (PSA) Response

Duration of response was not analyzed as majority of participants with objective tumor response were lost to follow-up.

Duration of Objective Tumor Response by Response Evaluation Criteria in Solid Tumors (RECIST)

Data was not analyzed because at the time to progression, participants also received dexamethasone treatment, making it impractical to accurately define disease progression.

Time to Disease Progression

Data was not analyzed due to high number of participants censored for survival.

Overall Survival

Baseline (n = 23)

Cycle 2 (n = 28)

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.

Serum Blood Levels of Testosterone

SAEs

Included all participants who received any amount of the study medication.

Number of Participants With Treatment-Emergent Adverse Events (AEs) or Serious Adverse Events (SAEs)

Cortisol; Baseline (n = 33)

Cortisol; Cycle 2 (n = 29)

Aldosterone; Baseline (n=33)

Aldosterone; Cycle 2 (n=29)

Corticosterone; Baseline (n=33)

Corticosterone; Cycle 2 (n=27)

11-Deoxycortisol; Baseline (n=31)

11-Deoxycortisol; Cycle 2 (n=25)

Deoxycorticosterone; Baseline (n=32)

Deoxycorticosterone; Cycle 2 (n=28)

DHEA-S; Baseline (n=32)

DHEA-S; Cycle 2 (n=28)

Serum Blood Levels of Testosterone Precursors

Median time was not reached as data was not matured at the time of the analysis, hence no data could be reported.

Time to Prostate Cancer Pain Progression

Data was reported in individual participant listings but not summarized due to statistical constraints.

Number of Participants With Change From Baseline in Biochemical Bone Markers

Abiraterone acetate 250 mg capsule given orally daily for 28-day treatment period to determine the maximum tolerated dose (MTD) in Phase 1 of the study.

Abiraterone Acetate 250 mg

Abiraterone acetate 500 mg capsules (2 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.

Abiraterone Acetate 500 mg

Abiraterone acetate 750 mg capsules (3 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.

Abiraterone Acetate 750 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.

Abiraterone Acetate 1000 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.

Abiraterone Acetate 2000 mg

Data was not statistically summarized but reported in individual participant listing as per planned analysis.

Mean Plasma Concentration of Abiraterone

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.

Maximum Observed Plasma Concentration (Cmax) of Abiraterone

Time to Reach Maximum Observed Plasma Concentration (Tmax) of Abiraterone

Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) of Abiraterone

Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0 - ∞)] of Abiraterone

Plasma Decay Half-Life (t1/2) of Abiraterone

Time to Last Quantifiable Plasma Concentration (Tlast) of Abiraterone

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.

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