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| ID | Type | Description | Link |
|---|---|---|---|
| COU-AA-001EXT | Other Identifier | Janssen Research & Development, LLC | |
| 2006-006755-12 | EudraCT Number |
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The purpose of this study is to provide access to abiraterone acetate for patients who have completed 12 cycles of abiraterone acetate treatment in Clinical Study COU-AA-001 and continue to receive clinical benefit from this treatment.
This is an open-label (identity of study drug will be known) extended access study to evaluate the safety and efficacy of continued administration of abiraterone acetate in patients who have completed 12 cycles of abiraterone acetate treatment in Clinical Study COU-AA-001 and continue to receive clinical benefit from this treatment. Patients will continue with the same dose regimen administered at the end of Study COU-AA-001 and will receive a low-dose glucocorticoid daily. Patients will be followed every 3 months for disease progression and survival for up to 3 years following study entry. Safety will be monitored throughout the study up to 30 days after the last dose of study medication.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Abiraterone acetate | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Abiraterone acetate | Drug | Phase 2 maximum tolerated dose from Study COU-AA-001 taken orally once daily |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of participants with serum prostate specific antigen (PSA) decline according to PSA Working Group criteria | Screening, Cycle 1 Day 1 Pre-dose, every 3 months up to 3 years after study entry | |
| Overall survival | every 3 months up to 3 years after study entry |
| Measure | Description | Time Frame |
|---|---|---|
| Number of participants with adverse events | up to 30 days after the last dose of study medication | |
| Time to disease progression | every 3 months up to 3 years after study entry | |
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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 |
|---|---|---|---|---|---|---|
| Sutton | United Kingdom |
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| Label | URL |
|---|---|
| An Expanded Access Open Label Study of CB7630 (Abiraterone Acetate) in Patients with Advanced Prostate Cancer Who Have Completed CB7630 Clinical Study COU-AA-001 | View source |
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| Glucocorticoid | Drug | prednisolone/prednisone 5 mg taken orally twice daily or dexamethasone 0.5 mg taken orally once daily |
|
| Time to prostate specific antigen progression |
| every 3 months up to 3 years after study entry |
| Objective tumor response by Response Evaluation Criteria in Solid Tumors (RECIST) | every 3 months up to 3 years after study entry |
| 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 |
| D005938 | Glucocorticoids |
| ID | Term |
|---|---|
| D000736 | Androstenes |
| D000731 | Androstanes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D000305 | Adrenal Cortex Hormones |
| D006728 | Hormones |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |
| D045505 | Physiological Effects of Drugs |
| D020228 | Pharmacologic Actions |
| D020164 | Chemical Actions and Uses |
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