A Phase 2 interventional study of Abiraterone acetate and Glucocorticoid in Prostate Neoplasms, sponsored by Cougar Biotechnology, Inc.. Completed at 3 sites in 2 countries. Open to male participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2014-05-12.
Sponsored by Cougar Biotechnology, Inc. (part of Johnson & Johnson) · Phase 2, Interventional, and Treatment
The purpose of this study is to assess the anti-tumor activities and safety of abiraterone acetate in participants with prostate cancer (a disease in which cells in the prostate gland [a gland in the male reproductive system found below the bladder and in front of the rectum] become abnormal and start to grow uncontrollably, forming tumors) who have failed taxane (docetaxel)-based chemotherapy.
This is an open-label (all people know the identity of the intervention), single arm, multicenter (when more than one hospital or medical school team work on a medical research study) study to evaluate the anti-tumor activities and safety of abiraterone acetate in participants with cancer who have failed taxane (docetaxel)-based chemotherapy. Abiraterone acetate 1000 milligram (mg) tablet or capsule will be administered orally (by mouth), once daily after an overnight fast until disease progression, lack of disease response after six 28-day cycles of treatment, or when unacceptable toxicity is encountered. Participants will be treated for up to 12 cycles. All participants will receive a concurrent low-dose glucocorticoid (such as prednisone 5 mg tablet twice daily/prednisolone 0.5 mg tablet once daily). Treatment will be continued in responding participants until death, or disease progression, or end of the study (which is Week 148). Efficacy will primarily be assessed through prostate specific antigen response according to Prostate Specific Antigen Working Group (PSAWG) criteria. Participants' safety will be monitored throughout the study. Participants who have completed 12 cycles of abiraterone acetate treatment, and continue to receive clinical benefit from such treatment, will be eligible to enter the extension study. Participants who enter the extension study will continue taking abiraterone acetate at the dose they were receiving at the end of the main study together with low-dose glucocorticoid. Efficacy and safety will be monitored throughout the extension study. Study treatment will end when the patient dies, is lost to follow-up, withdraws informed consent, experiences sustained side-effects, has disease progression, or the sponsor discontinues the extension study. After the end of study visit is completed for the extension study, participants will be followed every 12 weeks for survival for up to 3 years following entry into the extension study.
6,484 studies on the registry are indexed under Prostatic Neoplasms; 1,415 are open to participants now.
This study's enrollment of 47 is below the median of 58 across 4,908 interventional studies indexed under Prostatic Neoplasms.
Browse Prostatic Neoplasms studies →Cougar Biotechnology, Inc. is the lead sponsor of 12 studies on the registry; none are open to participants now.
First submitted before Cougar Biotechnology, Inc. became part of Johnson & Johnson.
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Exclusion Criteria:
Abiraterone acetate 1000 milligram (mg) tablet or capsule will be administered orally, once daily continuously in 28-day cycle up to disease progression, death, or end of study, along with prednisone/prednisolone 5 mg tablet orally twice daily or dexamethasone 0.5 mg tablet orally once daily.
Drug: Abiraterone acetate · Drug: Glucocorticoid
Abiraterone acetate 1000 milligram (mg) capsule or tablet will be administered orally, once daily continuously in 28-day cycle up to disease progression, death, or end of study.
Prednisone/prednisolone 5 mg tablet orally twice daily/dexamethasone 0.5 mg tablet orally once daily continuously in 28-day cycle up to disease progression, death, or end of study.
Percentage of Participants With Confirmed Prostate Specific Antigen (PSA) Response at Week 12
The PSA response was evaluated according to Prostate-Specific Antigen Working Group (PSAWG) criteria, which was, greater than or equal to 50 percent decrease in PSA from Baseline and confirmed by subsequent measurement at least 4 weeks later.
Time frame: Baseline, Week 12
Percentage of Participants With Confirmed Prostate Specific Antigen (PSA) Response
The PSA response was evaluated according to Prostate-Specific Antigen Working Group (PSAWG) criteria, which was, greater than or equal to 50 percent decrease in PSA from Baseline and confirmed by subsequent measurement at least 4 weeks later.
Time frame: Baseline up to Week 12
Percentage of Participants With Confirmed Objective Tumor Response as Per Response Evaluation Criteria in Solid Tumors (RECIST)
The objective tumor response was defined as the percentage of participants achieving a complete (CR) or partial response (PR) on tumor response assessed as per RECIST. The CR was disappearance of all lesions. The PR was at least a 30 percent decrease in the sum of the longest diameter (LD) of target lesions, taking as reference the Baseline sum LD.
Time frame: Baseline until first documented disease progression or end of study visit (Week 148; assessed on Day 1 of Cycle 4, 7, 10, and thereafter Day 1 of each cycle)
Time to PSA Progression
The time to PSA progression was the interval from the date of the first dose of abiraterone acetate to the date of PSA progression as defined by the PSAWG criteria. PSA progression was defined as a 50 percent increase over the nadir PSA value, increase in the PSA level by at least 5 nanogram per milliliter (ng/mL), and confirmed by second consecutive measurement.
Time frame: Baseline until first documented disease progression or up to end of study (Week 148; assessed on Days 1, 8 of Cycle 1, thereafter Day 1 of each Cycle)
Duration of PSA Response
Duration of PSA response was the time between the date of first PSA response (greater than or equal to 50 percent decline from Baseline) and the date of PSA progression as defined by the PSAWG. PSA progression was defined as a 50 percent increase over the nadir PSA value, increase in the PSA level by at least 5 nanogram per milliliter (ng/mL), and confirmed by second consecutive measurement.
Time frame: Baseline until first documented disease progression or up to end of study (Week 148; assessed on Days 1, 8 of Cycle 1, thereafter Day 1 of each Cycle)
Progression Free Survival Time
Progression Free Survival was defined as the interval from the date of the first dose of abiraterone acetate to the date of death or date of progressive disease (PD) as assessed by RECIST criteria. PD was at least 20 percent increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions.
Time frame: Baseline until first documented disease progression or death or up to end of study (Week 148; assessed on Day 1 of each cycle)
Overall Survival
Overall survival was defined as the interval from the date of the first dose of abiraterone acetate to the date of death.
Time frame: Baseline until death, or end of study (Week 148)
Shift From Baseline in Number of Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status Score at Post-dose (Week 148)
The ECOG performance status score ranges from 0 to 5 where 0=fully active, perform all pre-disease activities without restriction; 1=restricted in physically strenuous activity but ambulatory, carry out work of a light or sedentary nature; 2=ambulatory, capable of self-care, unable to carry out any work activities, up and about more than (\>) 50 percentage of waking hours; 3=capable of limited self-care, confined to bed or chair \>50 percentage of waking hours; 4=completely disabled, not capable of any self-care, totally confined to bed or chair; and 5=dead.
Time frame: Baseline until first documented disease progression or up to end of study (Week 148; assessed on Day 1 of each cycle)
The 5 participants in the Extension Study received treatment until they experienced progressive disease.
| Milestone | Abiraterone Acetate (Main Study) | Arbitarone Acetate (Extension) |
|---|---|---|
| Started | 47 | 0 |
| Completed | 11 | 0 |
| Not completed | 36 | 0 |
| Withdrew: Adverse event | 11 | 0 |
| Withdrew: Symptomatic deterioration | 1 | 0 |
| Withdrew: Progressive disease | 23 | 0 |
| Withdrew: Other | 1 | 0 |
| Milestone | Abiraterone Acetate (Main Study) | Arbitarone Acetate (Extension) |
|---|---|---|
| Started | 11 | 0 |
| Completed | 5 | 0 |
| Not completed | 6 | 0 |
| Withdrew: Did not enter extension phase | 6 | 0 |
| Milestone | Abiraterone Acetate (Main Study) | Arbitarone Acetate (Extension) |
|---|---|---|
| Started | 0 | 5 |
| Completed | 0 | 0 |
| Not completed | 0 | 5 |
| Withdrew: Progressive disease | 0 | 5 |
The PSA response was evaluated according to Prostate-Specific Antigen Working Group (PSAWG) criteria, which was, greater than or equal to 50 percent decrease in PSA from Baseline and confirmed by subsequent measurement at least 4 weeks later.
| percentage of participants | Abiraterone Acetate |
|---|---|
| Percentage of Participants With Confirmed Prostate Specific Antigen (PSA) Response at Week 12 | 36.2 (22.7 to 51.5) |
The PSA response was evaluated according to Prostate-Specific Antigen Working Group (PSAWG) criteria, which was, greater than or equal to 50 percent decrease in PSA from Baseline and confirmed by subsequent measurement at least 4 weeks later.
| percentage of participants | Abiraterone Acetate |
|---|---|
| Percentage of Participants With Confirmed Prostate Specific Antigen (PSA) Response | 44.7 (30.2 to 59.9) |
The objective tumor response was defined as the percentage of participants achieving a complete (CR) or partial response (PR) on tumor response assessed as per RECIST. The CR was disappearance of all lesions. The PR was at least a 30 percent decrease in the sum of the longest diameter (LD) of target lesions, taking as reference the Baseline sum LD.
| percentage of participants | Abiraterone Acetate |
|---|---|
| Percentage of Participants With Confirmed Objective Tumor Response as Per Response Evaluation Criteria in Solid Tumors (RECIST) | 26.1 (10.2 to 48.4) |
The time to PSA progression was the interval from the date of the first dose of abiraterone acetate to the date of PSA progression as defined by the PSAWG criteria. PSA progression was defined as a 50 percent increase over the nadir PSA value, increase in the PSA level by at least 5 nanogram per milliliter (ng/mL), and confirmed by second consecutive measurement.
| days | Abiraterone Acetate |
|---|---|
| Time to PSA Progression | 169 (113 to 281) |
Duration of PSA response was the time between the date of first PSA response (greater than or equal to 50 percent decline from Baseline) and the date of PSA progression as defined by the PSAWG. PSA progression was defined as a 50 percent increase over the nadir PSA value, increase in the PSA level by at least 5 nanogram per milliliter (ng/mL), and confirmed by second consecutive measurement.
| days | Abiraterone Acetate |
|---|---|
| Duration of PSA Response | 169 (141 to 262) |
Progression Free Survival was defined as the interval from the date of the first dose of abiraterone acetate to the date of death or date of progressive disease (PD) as assessed by RECIST criteria. PD was at least 20 percent increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions.
| days | Abiraterone Acetate |
|---|---|
| Progression Free Survival Time | 457 (163 to 712) |
Overall survival was defined as the interval from the date of the first dose of abiraterone acetate to the date of death.
| days | Abiraterone Acetate |
|---|---|
| Overall Survival | 380 (311 to 457) |
The ECOG performance status score ranges from 0 to 5 where 0=fully active, perform all pre-disease activities without restriction; 1=restricted in physically strenuous activity but ambulatory, carry out work of a light or sedentary nature; 2=ambulatory, capable of self-care, unable to carry out any work activities, up and about more than (\>) 50 percentage of waking hours; 3=capable of limited self-care, confined to bed or chair \>50 percentage of waking hours; 4=completely disabled, not capable of any self-care, totally confined to bed or chair; and 5=dead.
| participants | Abiraterone Acetate |
|---|---|
| Baseline, ECOG 0 | 16 |
| Baseline, ECOG 1 | 27 |
| Baseline, ECOG 2 | 4 |
| Best Post-Baseline. ECOG 0 | 25 |
| Best Post-Baseline. ECOG 1 | 19 |
| Best Post-Baseline. ECOG 2 | 3 |
Collected over From the first dose of study medication until 30 days after the last dose of study medication. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Abiraterone Acetate | — | 27/47 (57.4%) | 46/47 (97.9%) |
| Event | Abiraterone Acetate |
|---|---|
| AnaemiaBlood and lymphatic system disorders | 5/47 |
| NauseaGastrointestinal disorders | 4/47 |
| VomitingGastrointestinal disorders | 3/47 |
| AnorexiaMetabolism and nutrition disorders | 3/47 |
| Adrenal insufficiencyEndocrine disorders | 2/47 |
| ConstipationGastrointestinal disorders | 2/47 |
| DiarrhoeaGastrointestinal disorders | 2/47 |
| SepsisInfections and infestations | 2/47 |
| Femur fractureInjury, poisoning and procedural complications | 2/47 |
| Back painMusculoskeletal and connective tissue disorders | 2/47 |
| Event | Abiraterone Acetate |
|---|---|
| HypokalaemiaMetabolism and nutrition disorders | 29/47 |
| FatigueGeneral disorders | 25/47 |
| ArthralgiaMusculoskeletal and connective tissue disorders | 14/47 |
| Oedema peripheralGeneral disorders | 13/47 |
| AnorexiaMetabolism and nutrition disorders | 13/47 |
| ConstipationGastrointestinal disorders | 11/47 |
| DiarrhoeaGastrointestinal disorders | 11/47 |
| NauseaGastrointestinal disorders | 10/47 |
| VomitingGastrointestinal disorders | 10/47 |
| HypertensionVascular disorders | 10/47 |
| Age, Continuous(years) | Abiraterone Acetate |
|---|---|
| Mean | 67 ± 8.42 |
| Sex: Female, Male(Participants) | Abiraterone Acetate |
|---|---|
| Female | 0 |
| Male | 47 |
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Studies of the drug tested here: Abiraterone Acetate