Ignite Creation Date:
2024-05-05 @ 10:00 AM
Last Modification Date:
2024-10-26 @ 9:05 AM
Study NCT ID:
NCT00005848
Status:
COMPLETED
Last Update Posted:
2013-07-11
First Post:
2000-06-02
Brief Title:
R115777 in Treating Patients With Progressive Metastatic Prostate Cancer That Has Not Responded to Hormone Therapy
Sponsor:
Fox Chase Cancer Center
Organization:
Fox Chase Cancer Center
Study Overview
Official Title:
Phase II Trial of R115777 NSC 702818 an Inhibitor of Farnesyl Protein Transferase in Patients With Hormone Refractory Prostate Cancer
Status:
COMPLETED
Status Verified Date:
2013-07
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 Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die
PURPOSE Phase II trial to study the effectiveness of R115777 in treating patients who have progressive metastatic prostate cancer that has not responded to hormone therapy
PURPOSE Phase II trial to study the effectiveness of R115777 in treating patients who have progressive metastatic prostate cancer that has not responded to hormone therapy
Detailed Description:
OBJECTIVES I Determine whether R115777 has any antitumor activity in patients with progressive metastatic hormone refractory prostate cancer II Determine the safety and pharmacokinetics of this regimen in this patient population
OUTLINE Patients receive oral R115777 every 12 hours on days 1-21 Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity Patients are followed every 3 months
PROJECTED ACCRUAL A total of 15-30 patients will be accrued for this study within 10-16 months
OUTLINE Patients receive oral R115777 every 12 hours on days 1-21 Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity Patients are followed every 3 months
PROJECTED ACCRUAL A total of 15-30 patients will be accrued for this study within 10-16 months
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 |
|---|---|---|---|
| NCI-20 | OTHER_GRANT | National Cancer Institute | None |
| CDR0000067866 | REGISTRY | None | None |