Ignite Creation Date:
2024-05-05 @ 11:38 AM
Last Modification Date:
2024-10-26 @ 9:10 AM
Study NCT ID:
NCT00093457
Status:
COMPLETED
Last Update Posted:
2023-08-04
First Post:
2004-10-06
Brief Title:
Sorafenib in Treating Patients With Metastatic or Recurrent Prostate Cancer
Sponsor:
NCIC Clinical Trials Group
Organization:
Canadian Cancer Trials Group
Study Overview
Official Title:
A Phase II Study Of BAY 43-9006 NSC 724772 CTEP IND 69896 In Patients With Hormone Refractory Prostate Cancer
Status:
COMPLETED
Status Verified Date:
2020-04
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:
RATIONALE Sorafenib may stop the growth of tumor cells by blocking the enzymes necessary for their growth
PURPOSE This phase II trial is studying the effectiveness of sorafenib in treating patients who have metastatic or recurrent prostate cancer that has not responded to previous hormone therapy
PURPOSE This phase II trial is studying the effectiveness of sorafenib in treating patients who have metastatic or recurrent prostate cancer that has not responded to previous hormone therapy
Detailed Description:
OBJECTIVES
Determine the efficacy of sorafenib as measured by prostate-specific antigen response in patients with metastatic or recurrent hormone-refractory adenocarcinoma of the prostate
Secondary
Determine the objective response rate and duration of response in patients treated with this drug
Determine the tolerability and toxicity of this drug in these patients
Determine time to treatment failure and overall survival in patients treated with this drug
Explore the relationship between measures of rasraf pathway activation pERK and response to treatment in these patients
OUTLINE This is a non-randomized multicenter study
Patients receive oral sorafenib twice daily on days 1-28 Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity
Patients are followed at 4 weeks after going off study treatment and then periodically for survival Patients with stable or responding disease when they go off study treatment are followed every 3 months until relapse or progression
PROJECTED ACCRUAL Approximately 15-25 patients will be accrued for this study within 12-18 months
Determine the efficacy of sorafenib as measured by prostate-specific antigen response in patients with metastatic or recurrent hormone-refractory adenocarcinoma of the prostate
Secondary
Determine the objective response rate and duration of response in patients treated with this drug
Determine the tolerability and toxicity of this drug in these patients
Determine time to treatment failure and overall survival in patients treated with this drug
Explore the relationship between measures of rasraf pathway activation pERK and response to treatment in these patients
OUTLINE This is a non-randomized multicenter study
Patients receive oral sorafenib twice daily on days 1-28 Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity
Patients are followed at 4 weeks after going off study treatment and then periodically for survival Patients with stable or responding disease when they go off study treatment are followed every 3 months until relapse or progression
PROJECTED ACCRUAL Approximately 15-25 patients will be accrued for this study within 12-18 months
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
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 |
|---|---|---|---|
| CDR0000387987 | OTHER | PDQ | None |
| CAN-NCIC-IND167 | OTHER | None | None |