Ignite Creation Date:
2024-05-05 @ 11:21 AM
Last Modification Date:
2024-10-26 @ 9:04 AM
Study NCT ID:
NCT00005041
Status:
COMPLETED
Last Update Posted:
2012-11-09
First Post:
2000-04-06
Brief Title:
R115777 in Treating Patients With Relapsed Small Cell Lung Cancer
Sponsor:
NYU Langone Health
Organization:
NYU Langone Health
Study Overview
Official Title:
A Phase II Study to Determine the Antitumor Activity of Farnesyltransferase Inhibitor R115777 in Subjects With Relapsed Small Cell Lung Cancer
Status:
COMPLETED
Status Verified Date:
2000-11
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 relapsed small cell lung cancer
PURPOSE Phase II trial to study the effectiveness of R115777 in treating patients who have relapsed small cell lung cancer
Detailed Description:
OBJECTIVES I Determine the objective response rate complete or partial and duration of response of patients with small cell lung cancer who have had at least a partial response to one prior chemotherapy regimen for at least 3 months when treated with R115777 II Determine the time to disease progression survival and quality of life in this patient population treated with this drug III Assess the safety of R115777 in this patient population IV Assess the presence of ras mutations in relapsed patients with available paraffin blocks
OUTLINE This is a multicenter study Patients receive oral R115777 every 12 hours for 14 consecutive days followed by 7 days of rest Treatment continues in the absence of unacceptable toxicity or disease progression Quality of life is assessed at baseline on day 15 of each course and at the end of the study
PROJECTED ACCRUAL A total of 27-40 patients will be accrued for this study
OUTLINE This is a multicenter study Patients receive oral R115777 every 12 hours for 14 consecutive days followed by 7 days of rest Treatment continues in the absence of unacceptable toxicity or disease progression Quality of life is assessed at baseline on day 15 of each course and at the end of the study
PROJECTED ACCRUAL A total of 27-40 patients will be accrued for this 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 |
|---|---|---|---|
| NCI-G00-1714 | None | None | None |
| NYU-9861 | None | None | None |
| JRF-R115777-USA-8B | None | None | None |