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An Open Label Phase II Study of Tipifarnib in Subjects with Relapsed or Refractory Peripheral T-Cell Lymphoma
The main purpose of this study is to determine the safety and efficacy of an investigational new drug (tipifarnib, the study drug) in treating Peripheral T-Cell Lymphoma (PTCL).
Primary Objective: To determine the antitumor activity in terms of objective response rate (ORR) of tipifarnib in subjects with relapsed or refractory peripheral T-cell lymphoma (PTCL). Secondary Objective 1: To determine the antitumor activity in terms of progression free survival (PFS) and duration of response (DOR) of tipifarnib in subjects with relapsed or refractory PTCL. Secondary Objective 2: Safety and tolerability of tipifarnib in subjects with relapsed or refractory PTCL. Exploratory Objective: To explore the feasibility of collecting tissue biopsies and blood samples and analysing these biopsies and samples for the detection of biomarkers potentially related to tipifarnib activity.