Ignite Creation Date:
2024-05-05 @ 11:20 AM
Last Modification Date:
2024-10-26 @ 9:05 AM
Study NCT ID:
NCT00005990
Status:
COMPLETED
Last Update Posted:
2012-11-09
First Post:
2000-07-05
Brief Title:
R115777 Plus Topotecan in Treating Patients With Advanced Solid Tumors
Sponsor:
NYU Langone Health
Organization:
NYU Langone Health
Study Overview
Official Title:
Phase I and Pharmacokinetic Study of the Farnesyl Transferase Inhibitor R115777 in Combination With Topotecan
Status:
COMPLETED
Status Verified Date:
2006-01
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 Combining more than one drug may kill more tumor cells
PURPOSE Phase I trial to study the effectiveness of R115777 plus topotecan in treating patients who have advanced solid tumors
PURPOSE Phase I trial to study the effectiveness of R115777 plus topotecan in treating patients who have advanced solid tumors
Detailed Description:
OBJECTIVES
Determine the dose-limiting toxic effects of R115777 and topotecan in patients with advanced solid tumors
Determine the maximum tolerated dose of this regimen in these patients
Determine pharmacokinetic profiles of topotecan alone and in combination with R115777 in these patients
Measure the inhibition of ras-farnesylation and topo-1 inhibition in peripheral blood mononuclear cells in these patients when treated with this regimen
Determine activity of this treatment in these patients
OUTLINE This is a dose-escalation multicenter study
Patients receive oral R115777 twice daily on days 2-21 in the first course only R115777 begins on day 3 and topotecan IV continuously on days 1-21 Treatment continues every 28 days in the absence of disease progression or unacceptable toxicity
Cohorts of 3-6 patients receive escalating doses of R115777 and topotecan until the maximum tolerated dose MTD is determined The MTD is defined as the dose at which 2 of 3 or 6 patients experience dose-limiting toxicity
PROJECTED ACCRUAL A total of 18-24 patients will be accrued for this study
Determine the dose-limiting toxic effects of R115777 and topotecan in patients with advanced solid tumors
Determine the maximum tolerated dose of this regimen in these patients
Determine pharmacokinetic profiles of topotecan alone and in combination with R115777 in these patients
Measure the inhibition of ras-farnesylation and topo-1 inhibition in peripheral blood mononuclear cells in these patients when treated with this regimen
Determine activity of this treatment in these patients
OUTLINE This is a dose-escalation multicenter study
Patients receive oral R115777 twice daily on days 2-21 in the first course only R115777 begins on day 3 and topotecan IV continuously on days 1-21 Treatment continues every 28 days in the absence of disease progression or unacceptable toxicity
Cohorts of 3-6 patients receive escalating doses of R115777 and topotecan until the maximum tolerated dose MTD is determined The MTD is defined as the dose at which 2 of 3 or 6 patients experience dose-limiting toxicity
PROJECTED ACCRUAL A total of 18-24 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-T99-0110 | None | None | None |
| NYU-9932 | None | None | None |