Ignite Creation Date:
2024-05-05 @ 11:23 AM
Last Modification Date:
2024-10-26 @ 9:06 AM
Study NCT ID:
NCT00012350
Status:
COMPLETED
Last Update Posted:
2012-10-23
First Post:
2001-03-03
Brief Title:
Phase II Evaluation of FTase Inhibitor FTIin Treatment of Advanced Multiple Myeloma
Sponsor:
H Lee Moffitt Cancer Center and Research Institute
Organization:
H Lee Moffitt Cancer Center and Research Institute
Study Overview
Official Title:
Phase II Evaluation of FTI R115777 NSC 702818 in Treatment of Advanced Multiple Myeloma
Status:
COMPLETED
Status Verified Date:
2012-10
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 cancer 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 or refractory multiple myeloma
PURPOSE Phase II trial to study the effectiveness of R115777 in treating patients who have relapsed or refractory multiple myeloma
Detailed Description:
OBJECTIVES I Determine the rate of objective response and disease stabilization in patients with relapsed or refractory multiple myeloma treated with R115777 II Determine whether the degree of inhibition of FTase activity and farnesylation of lamin-B H- K- and N-RAS in peripheral blood mononuclear cells and tumor tissue correlates with tumor response in patients treated with this regimen III Determine whether the presence of activating RAS mutations in myeloma cells predicts treatment response in patients treated with this regimen IV Correlate R115777 plasma levels and RAS mutation status with tumor response in patients treated with this regimen
OUTLINE Patients receive oral R115777 twice daily on days 1-21 Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity Patients are followed for at least 30 days
PROJECTED ACCRUAL Approximately 12-42 patients will be accrued for this study within 25 months
OUTLINE Patients receive oral R115777 twice daily on days 1-21 Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity Patients are followed for at least 30 days
PROJECTED ACCRUAL Approximately 12-42 patients will be accrued for this study within 25 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 |
|---|---|---|---|
| NIH-2030 | OTHER | NIH | None |