Viewing Study NCT00391560



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Last Modification Date: 2024-10-26 @ 9:28 AM
Study NCT ID: NCT00391560
Status: COMPLETED
Last Update Posted: 2018-03-14
First Post: 2006-10-20

Brief Title: Phase II Study of Perifosine in Patients With Refractory and Relapsed Leukemia
Sponsor: AEterna Zentaris
Organization: AEterna Zentaris

Study Overview

Official Title: Phase II Study of Perifosine in Patients With Refractory and Relapsed Leukemia
Status: COMPLETED
Status Verified Date: 2012-02
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 trial designed to determine the efficacy and safety of perifosine in patients with leukemia who develop progressive disease or recurrence while receiving therapy
Detailed Description: This is a Phase II study of perifosine in patients with refractory and relapsed leukemia After a one time loading dose of 600 mg 150 mg x 4 at least 4 hours apart during the first cycle perifosine will be given orally at 100 mg once a day continuously Cycles are 28 days in length Intra-patient dose escalation for the maintenance dose to 150 mg daily will be done in the second cycle if no non-hematological toxicities beyond grade 0-1 occurred during the first cycle are observed

Patients will be assessed for efficacy at the end of each 28 day cycle of therapy - 7 days Complete remissions partial remissions and hematological improvements of any kind will be counted towards an objective response for all diseases

A maximum total of 74 patients will be enrolled on the study all of them assigned to the same experimental treatment scheme arm described above

A maximum total of 37 evaluable patients will be entered in each of two diagnostic groups which are being distinguished due to different anticipated rates of accrual Group 1 AML MDS CML-BP non-lymphoid CMML Agnogenic Myeloid Metaplasia AMM Group 2 CLL ALL CML-BP lymphoid

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