NCT00847223

Efficacy and Safety of the Farnesyl-transferase Inhibitor (Tipifarnib) in Mantle Cell Lymphoma

A Phase II Study Evaluating the Efficacy and Safety of the Farnesyl-transferase Inhibitor ZARNESTRA® in Patients With Relapsed, Refractory or Progressive Mantle Cell Lymphoma Not Appropriate for Autologous Bone Marrow Transplantation

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 11 (actual)
• Sponsor: Lymphoma Study Association · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

To determine the EFFICACY and the SAFETY PROFILE and TOXICITY of Zarnestra® in the treatment of patients with previously treated mantle cell lymphoma not appropriate for autologous bone marrow transplantation. 27 evaluable subjects will be enrolled for an analysis in 2 stages (11 for the first stage, 16 for the second). Patients who receive at least one dose of Zarnestra® and have at least one post-baseline response assessment of discontinued study frug for early progression are evaluable. Subjects not evaluable for response will be replaced, up to 35 patients.

Detailed description

Zarnestra® will be administered at 300 mg administered orally twice daily for the first 21 days of each 28-days cycle. Tipifarnib treatment stops no later than day 21 of each cycle. Subjects will receive a total of 4 cycles of treatment. Two additional cycles might be administered for patients showing improvement to PR after 4 cycles. After testing the drug on 11 patients in the first stage, the trial will be terminated if 1 or fewer respond and the drug will not be considered as effective. If two or more patients respond in the first stage, the trial goes on to the second stage to include a total of 27 patients.

Conditions

• Mantle Cell Lymphoma

Interventions

Type	Name	Description
DRUG	ZARNESTRA (Tipifarnib)

Timeline

• Start date: 2007-06-01
• Primary completion: 2009-03-01
• Completion: 2009-03-01
• First posted: 2009-02-19
• Last updated: 2018-08-23