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| ID | Type | Description | Link |
|---|---|---|---|
| COU-AA-006 | Other Identifier | Janssen Research & Development, LLC |
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The purpose of this study is to determine the effect of abiraterone acetate plus prednisone on the conduction of electric charges within the heart and to determine the blood levels of abiraterone acetate following administration in patients with metastatic castration-resistant prostate cancer.
This is an open-label (identity of assigned study drugs will be known) study to evaluate the effects of abiraterone acetate plus prednisone on the conduction of electric charges within the heart in male patients diagnosed with metastatic castration-resistant prostate cancer (a progressive form of prostate cancer that spreads to other parts of the body). At various time points outline in the protocol from Day -1 of Cycle 1 up to Day 2 of Cycle 2, patients will have electrocardiograms extracted from a 24 hour holter-monitor to evaluate the electrical activity of their heart. Efficacy will be assessed according to Prostate Cancer Working Group 2 and modified Response Evaluation Criteria In Solid Tumors criteria. Serial blood samples for pharmacokinetic analysis (how the drug concentrations change over time) will be collected and safety will be monitored throughout the study. Patients will take 1000 mg of abiraterone acetate once daily plus prednisone 5 mg twice daily orally (by mouth) until disease progression and will be followed up for up to 60 months.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Abiraterone acetate | Experimental | Patients will take 1000 mg of abiraterone acetate once daily plus prednisone 5 mg twice daily orally (by mouth) until disease progression. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Abiraterone acetate | Drug | Abiraterone acetate 1000 mg (4 x 250 mg tablets) administered orally once daily. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Mean maximal change in electrocardiogram QTc | Baseline on Day -1 of Cycle 1 compared with Day 1 of Cycle 1, Cycle 2, Cycle 4 and every third cycle thereafter |
| Measure | Description | Time Frame |
|---|---|---|
| Number of participants with change from baseline electrocardiogram QTc >30 msec | Pre-dose Cycles 1, 2, 4, and every third cycle after Cycle 4, and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, and 24 hours post-dose, and end of study visit (4 weeks after last dose of study drug) | |
| Number of participants with change from baseline electrocardiogram QTc >60 msec |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Janssen Research & Development, LLC Clinical Trial | Janssen Research & Development, LLC | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Roswell Park Cancer Institute | Buffalo | New York | 14263 | United States | ||
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| Label | URL |
|---|---|
| A QT/QTc and Multi-dose PK Study of Abiraterone Acetate (CB7630) Plus Prednisone in Patients with Metastatic Castration- Resistant Prostate Cancer | View source |
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| Prednisone | Drug | Prednisone 5 mg tablets administered orally twice daily. |
|
| Pre-dose Cycles 1, 2, 4, and every third cycle after Cycle 4, and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, and 24 hours post-dose, and end of study visit (4 weeks after last dose of study drug) |
| Number of participants affected by an adverse event | Up to 30 days after the last dose of study medication |
| Number of participants with change in cortrosyn stimulation test | Baseline and end of study visit (4 weeks after last dose of study drug) |
| Number of participants with change in serum blood levels of testosterone | Baseline and end of study visit (4 weeks after last dose of study drug) |
| Number of participants with change in adrenocorticotropic hormone | Baseline and end of study visit (4 weeks after last dose of study drug) |
| Mean plasma concentrations of abiraterone | Pre-dose and 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, and 24 hours post-dose |
| Maximum plasma concentrations of abiraterone | Pre-dose and 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, and 24 hours post-dose |
| Time to reach the maximum plasma concentration of abiraterone | Pre-dose and 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, and 24 hours post-dose |
| Area under the plasma-concentration-time curve from time 0 to the last quantifiable concentration of abiraterone | Pre-dose and 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, and 24 hours post-dose |
| Area under the plasma-concentration-time curve from time 0 to infinite time of abiraterone | Pre-dose and 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, and 24 hours post-dose |
| Elimination half-life of abiraterone | Pre-dose and 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, and 24 hours post-dose |
| Radiographic progression free survival | Up to Month 60 |
| Overall survival | Up to Month 60 |
| Number of participants with prostate specific antigen response | Week 12 |
| Time to prostate specific antigen progression according to Prostate Cancer Working Group 2 criteria | Up to Month 60 |
| Number of participants with objective radiographic response according to Prostate Cancer Working Group 2 criteria | Up to Month 60 |
| Buffalo |
| New York |
| United States |
| Carolina Urologic Research Center | Myrtle Beach | South Carolina | 29572 | United States |
| Myrtle Beach | South Carolina | United States |
| South Texas Accelerated Research Therapeutics | San Antonio | Texas | 78229 | United States |
| San Antonio | Texas | United States |
| BC Cancer Agency-Vancouver | Vancouver | British Columbia | V5Z 4E6 | Canada |
| Vancouver | British Columbia | Canada |
| 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 |
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| ID | Term |
|---|---|
| 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 |
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