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Clinical Trial 18496

Cancer Type: Malignant Hematology
Interventions:Zarnestra (tipifarnib); tipifarnib

Study Type: Treatment
Phase of Study: Phase II

  • Lubomir Sokol

Call 813-745-6100
or 1-800-679-0775

Study Title

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.

Inclusion Criteria

  • Diagnosis of Peripheral T-Cell Lymphoma (PTCL) according to the most recent edition of the World Health Organization (WHO) Classification of Tumors of Hematopoietic or Lymphoid Tissues, as follows: Anaplastic large cell lymphoma (ALCL), ALK positive; ALCL, ALK negative; Angioimmunoblastic T-cell lymphoma (AITL); Enteropathy-associated T-cell lymphoma; Extranodal natural killer (NK) T-cell lymphoma, nasal type; Hepatosplenic T-cell lymphoma; Peripheral T-cell lymphoma, no otherwise specified (NOS); Subcutaneous panniculitis-like T-cell lymphoma
  • Relapsed or are refractory to at least 1 prior systemic cytotoxic therapy. Must have received conventional therapy as a prior therapy.
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0-2
  • Acceptable liver and renal function
  • Acceptable hematologic status
  • Female participants must be either: Of non-child-bearing potential (surgically sterilized or at least 2 years post-menopausal); or If of child-bearing potential, must use an adequate method of contraception consisting of two-barrier method or one barrier method with a spermicide or intrauterine device. Both females and male participants with female partners of child-bearing potential must agree to use an adequate method of contraception for 2 weeks prior to screening, during, and at least 4 weeks after last dose of trial medication. Female participants must have a negative serum or urine pregnancy test within 72 hours prior to start of trial medication. Female participants must not be breast feeding at any time during the study.
  • Written and voluntary informed consent.

  • Exclusion Criteria

  • Diagnosis of any of the following: Precursor T-cell lymphoma or leukemia; Adult T-cell lymphoma/leukemia (ATLL); T-cell prolymphocytic leukemia; T-cell large granular lymphocytic leukemia; Primary cutaneous type anaplastic large cell lymphoma; Mycosis fungoide/Sezary syndrome.
  • Ongoing treatment with an anticancer agent not contemplated in the study protocol.
  • Prior treatment (at least 1 full treatment cycle) with an FTase inhibitor.
  • Any history of clinically relevant coronary artery disease or myocardial infarction within the last 3 years, New York Heart Association (NYHA) grade III or greater congestive heart failure, cerebro-vascular attack within the prior year, or current serious cardiac arrhythmia requiring medication except atrial fibrillation.
  • Known central nervous system lymphoma.
  • Stem cell transplant less than 3 months prior to enrolment.
  • Non-tolerable greater than or equal to Grade 2 neuropathy or evidence of unstable neurological symptoms within 4 weeks of Cycle 1 Day 1.
  • Major surgery, other than diagnostic surgery, within 2 weeks prior to Cycle 1 Day 1, without complete recovery.
  • Other active malignancy requiring therapy such as radiation, chemotherapy, or immunotherapy.
  • Active, uncontrolled bacterial, viral, or fungal infections, requiring systemic therapy. Known infection with HIV, or an active infection with hepatitis B or hepatitis C.