Ignite Creation Date:
2024-05-05 @ 5:30 PM
Last Modification Date:
2024-10-26 @ 9:32 AM
Study NCT ID:
NCT00473746
Status:
COMPLETED
Last Update Posted:
2014-04-29
First Post:
2007-05-11
Brief Title:
Abiraterone Acetate Dose-Escalation Study in Hormone Refractory Prostate Cancer
Sponsor:
Janssen Research Development LLC
Organization:
Janssen Research Development LLC
Study Overview
Official Title:
Phase III Open Label Dose Escalation Study of the 17α-Hydroxylase C1720-Lyase Inhibitor Abiraterone Acetate in Hormone Refractory Prostate Cancer
Status:
COMPLETED
Status Verified Date:
2014-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The purpose of this study is to evaluate the safety pharmacokinetics pharmacodynamics and anti-tumor activities of abiraterone acetate also referred to as CB7630 in patients with hormone refractory prostate cancer HRPC
Detailed Description:
This is an open-label identity of assigned study drug will be known study to evaluate the safety pharmacokinetics study of what the body does to a drug pharmacodynamics study of what a drug does to the body and anti-tumor activities of abiraterone acetate also known as CB7630 in patients with HRPC The study will be conducted in 2 phases Phase 1 and Phase 2 In the first part of the study Phase 1 the maximum tolerated dose MTD of abiraterone acetate will be determined for use in the second part of the study Phase 2 where the number of patients who achieve at least a 50 decrease in prostate specific antigen PSA during treatment with abiraterone acetate will be assessed MTD from Phase 1 Abiraterone acetate will be taken orally by mouth in fed and fasted patients once daily Doses of abiraterone acetate starting at 250 mg up to a maximum of 2000 mg will be taken for 28-day treatment periods to determine the MTD Patients will take MTD of abiraterone acetate for up to twelve 28 day cycles 12 months patients will be given the option of staying on abiraterone acetate treatment if they are deriving benefit In Phase 2 prednisone or dexamethasone will be administered concurrently with abiraterone acetate Serial pharmacokinetic and pharmacodynamic samples will be collected and safety will be monitored throughout the study
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| COU-AA-002 | OTHER | Janssen Research Development LLC | None |