Ignite Creation Date:
2024-05-05 @ 11:34 AM
Last Modification Date:
2024-10-26 @ 9:10 AM
Study NCT ID:
NCT00083473
Status:
TERMINATED
Last Update Posted:
2005-08-30
First Post:
2004-05-24
Brief Title:
A Pilot Study of Pivanex in Patients With Chronic Lymphocytic Leukemia
Sponsor:
Titan Pharmaceuticals
Organization:
Titan Pharmaceuticals
Study Overview
Official Title:
A Pilot Study of Pivanex a Histone Deacetylase Inhibitor in Patients With Chronic Lymphocytic Leukemia
Status:
TERMINATED
Status Verified Date:
2005-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This pilot study will assess the safety and efficacy of Pivanex alone in patients with chronic lymphocytic leukemia CLL who have relapsed or refractory disease after previous chemotherapy treatment Pivanex is an investigational agent
Detailed Description:
Rationale Chronic lymphocytic leukemia CLL is a disease characterized by the accumulation of mature lymphocytes These CLL lymphocytes are blocked from undergoing terminal differentiation and apoptosis Patients with CLL have limited options for therapy especially after the failure of standard chemotherapy regimens Histone deacetylase inhibitors HDACs comprise a new class of drugs being evaluated in the treatment of various malignancies In vitro data suggest that HDAC inhibition leads to terminal B-cell differentiation and may therefore play a therapeutic role in the treatment of CLL Pivanex pivaloyloxymethyl butyrate is an HDAC inhibitor that has been shown to induce apoptosis of CLL lymphocytes in vitro In previous clinical trials Pivanex has been well tolerated The goal of this protocol is to determine the effects of Pivanex in patients with CLL
Purpose This open-label trial will determine the response rate of Pivanex in patients with CLL
Objectives 1 Determine the response rate of Pivanex in patients with relapsed CLL 2 Determine time to disease progression in patients with relapsed CLL treated with Pivanex and 3 Determine the safety profile of Pivanex in CLL
Design This is an open label single arm multiple dose pilot study of patients with relapsed CLL Patients will be treated with 25 gm2 of Pivanex administered intravenously over 6 hours daily on Days 1 - 3 Treatment will be repeated every 21 days until disease progression or the patient is withdrawn from treatment for protocol-specified reasons
Disease status will be assessed prior to every odd-numbered treatment cycle using response criteria based upon the Revised National Cancer Institute-sponsored Working Group Guidelines for CLL Patients withdrawn due to disease progression will be followed for survival Patients withdrawn from study for reasons other than disease progression will be followed for disease progression and survival
Purpose This open-label trial will determine the response rate of Pivanex in patients with CLL
Objectives 1 Determine the response rate of Pivanex in patients with relapsed CLL 2 Determine time to disease progression in patients with relapsed CLL treated with Pivanex and 3 Determine the safety profile of Pivanex in CLL
Design This is an open label single arm multiple dose pilot study of patients with relapsed CLL Patients will be treated with 25 gm2 of Pivanex administered intravenously over 6 hours daily on Days 1 - 3 Treatment will be repeated every 21 days until disease progression or the patient is withdrawn from treatment for protocol-specified reasons
Disease status will be assessed prior to every odd-numbered treatment cycle using response criteria based upon the Revised National Cancer Institute-sponsored Working Group Guidelines for CLL Patients withdrawn due to disease progression will be followed for survival Patients withdrawn from study for reasons other than disease progression will be followed for disease progression and survival
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