Ignite Creation Date:
2024-05-05 @ 5:09 PM
Last Modification Date:
2024-10-26 @ 9:28 AM
Study NCT ID:
NCT00398710
Status:
COMPLETED
Last Update Posted:
2018-03-15
First Post:
2006-11-09
Brief Title:
A Phase II Study of Perifosine in Patients With RelapsedRefractory Waldenströms Macroglobulinemia
Sponsor:
AEterna Zentaris
Organization:
AEterna Zentaris
Study Overview
Official Title:
A Phase II Study of Perifosine in Patients With RelapsedRefractory Waldenströms Macroglobulinemia
Status:
COMPLETED
Status Verified Date:
2011-11
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:
This is a phase II study in relapsedrefractory WM patients treated with perifosine It is designed to assess the proportion of overall confirmed responses CR PR MR using a two-stage phase II study design to permit early stopping of the trial if there is strong evidence that the study regimen is inactive In addition it will assess toxicity of this drug in patients with WM Patients will receive perifosine 150 mg qhs daily Patients will be assessed by serum immunoelectrophoresis and IgM level at least every 4 weeks
Detailed Description:
This is a phase II study in relapsedrefractory WM patients treated with perifosine It is designed to assess the proportion of overall confirmed responses CR PR MR using a two-stage phase II study design to permit early stopping of the trial if there is strong evidence that the study regimen is inactive In addition it will assess toxicity of this drug in patients with WM Patients will receive perifosine 150 mg qhs daily Patients will be assessed by serum immunoelectrophoresis and IgM level at least every 4 weeks
Patients will take three 50 mg tablets of perifosine qhs daily for 28 days cycles with food Patients may need anti-emetics andor anti-diarrheas All patients should continue therapy unless disease progression is documented on two occasions at least 1 week apart Patients with progressive disease or who refuse further therapy will be discontinued from the protocol Dose modifications for toxicity will be performed
Standard criteria for evaluation of response in WM recommended by the Second International WM Workshop will be used in this study
Patients will take three 50 mg tablets of perifosine qhs daily for 28 days cycles with food Patients may need anti-emetics andor anti-diarrheas All patients should continue therapy unless disease progression is documented on two occasions at least 1 week apart Patients with progressive disease or who refuse further therapy will be discontinued from the protocol Dose modifications for toxicity will be performed
Standard criteria for evaluation of response in WM recommended by the Second International WM Workshop will be used in 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