Efficacy and Safety of the Farnesyl-transferase Inhibitor (Tipifarnib) in Mantle Cell Lymphoma
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.
|Study Design:||Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||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|
- Efficacy measured by evaluation of the overall response rate (complete response [CR] + complete response unconfirmed [CRu] + partial response [PR]) to Zarnestra® as single agent, according to criteria based on those developed by Cheson and al. [ Time Frame: After 4 cycles ] [ Designated as safety issue: No ]
- To determine the overall CR rate (CR + CRu),progression-free survival (PFS), overall survival, to evaluate the safety and tolerability of Zarnestra®
|Study Start Date:||June 2007|
|Primary Completion Date:||March 2009 (Final data collection date for primary outcome measure)|
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00847223
|Study Chair:||Catherine THIEBLEMONT, MD||Lymphoma Study Association|
|Principal Investigator:||Hervé TILLY, MD||Lymphoma Study Association|
|Principal Investigator:||Catherine SEBBAN, MD||Lymphoma Study Association|
|Principal Investigator:||Bertrand COIFFIER, MD||Lymphoma Study Association|
|Principal Investigator:||Serge BOLOGNA, MD||Lymphoma Study Association|
|Principal Investigator:||Olivier CASASNOVAS, MD||Lymphoma Study Association|
|Principal Investigator:||Richard DELARUE, MD||Lymphoma Study Association|
|Principal Investigator:||Réda BOUABDALLAH, MD||Dr|
|Principal Investigator:||Franck MORSCHHAUSER, MD||Lymphoma Study Association|