Ignite Creation Date:
2024-05-05 @ 10:17 AM
Last Modification Date:
2024-10-26 @ 9:05 AM
Study NCT ID:
NCT00005989
Status:
COMPLETED
Last Update Posted:
2011-08-04
First Post:
2000-07-05
Brief Title:
R115777 in Treating Patients With Recurrent or Metastatic Non-small Cell Lung Cancer
Sponsor:
Mayo Clinic
Organization:
Mayo Clinic
Study Overview
Official Title:
A Phase II Study of Farnesyl Transferase Inhibitor R115777 in Patients With Advanced Non-Small Cell Lung Cancer
Status:
COMPLETED
Status Verified Date:
2011-08
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 recurrent or metastatic non-small cell lung cancer
PURPOSE Phase II trial to study the effectiveness of R115777 in treating patients who have recurrent or metastatic non-small cell lung cancer
Detailed Description:
OBJECTIVES
Assess the response rate of patients with recurrent or metastatic non-small cell lung cancer when treated with tipifarnib
Determine the clinical toxicities of this treatment in these patients
Assess the overall survival and time to progression of this patient population when treated with this regimen
Evaluate the inhibition of protein farnesylation in vivo and correlate such inhibition to plasma levels of tipifarnib
Evaluate the occurrence of CYP450 polymorphisms and relate these to drug toxicity pharmacokinetics and response to this treatment in this patient population
OUTLINE This is a multicenter study
Patients receive oral tipifarnib twice daily on days 1-21 Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity
Patients are followed every 3 months for 5 years
PROJECTED ACCRUAL A total of 50 patients will be accrued for this study over 12 months
Assess the response rate of patients with recurrent or metastatic non-small cell lung cancer when treated with tipifarnib
Determine the clinical toxicities of this treatment in these patients
Assess the overall survival and time to progression of this patient population when treated with this regimen
Evaluate the inhibition of protein farnesylation in vivo and correlate such inhibition to plasma levels of tipifarnib
Evaluate the occurrence of CYP450 polymorphisms and relate these to drug toxicity pharmacokinetics and response to this treatment in this patient population
OUTLINE This is a multicenter study
Patients receive oral tipifarnib twice daily on days 1-21 Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity
Patients are followed every 3 months for 5 years
PROJECTED ACCRUAL A total of 50 patients will be accrued for this study over 12 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 |
|---|---|---|---|
| 982401 | OTHER | Mayo Clinic IRB | httpsreporternihgovquickSearchP30CA015083 |
| U01CA069912 | NIH | None | None |
| P30CA015083 | NIH | None | None |