Trial Search Results

Study of Tipifarnib in Subjects With Relapsed or Refractory Peripheral T-Cell Lymphoma

The purpose of this study is to test the efficacy of an investigational drug, Tipifarnib, in participants previously diagnosed with relapsed or refractory peripheral T-Cell lymphoma across the United States.

Stanford is currently accepting patients for this trial.

Lead Sponsor:

Kura Oncology, Inc.

Intervention(s):

  • Drug: Tipifarnib

Phase:

Phase 2

Eligibility


Inclusion Criteria:

   - Diagnosis of PTCL according to the most recent edition of the World Health
   Organization (WHO) Classification of Tumors of Hematopoietic or Lymphoid Tissues, as
   follows:

      1. Anaplastic large cell lymphoma (ALCL), ALK positive

      2. ALCL, ALK negative

      3. Angioimmunoblastic T-cell lymphoma (AITL)

      4. Enteropathy-associated T-cell lymphoma

      5. Extranodal natural killer (NK) T-cell lymphoma, nasal type

      6. Hepatosplenic T-cell lymphoma

      7. Peripheral T-cell lymphoma, no otherwise specified (NOS)

      8. Subcutaneous panniculitis-like T-cell lymphoma For enrollment into the AITL
      expansion cohort, subjects must have he diagnosis of AITL.

   - Relapsed or are refractory to at least 1 prior systemic cytotoxic therapy. -Subjects
   must have received conventional therapy as a prior therapy.

   - ECOG performance status of 0-2

   - Acceptable liver and renal function

   - Acceptable hematologic status

   - Female subjects must be either:

      1. Of non-child-bearing potential (surgically sterilized or at least 2 years
      post-menopausal); or

      2. If of child-bearing potential, subject 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 subjects 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 subjects must have a negative serum or
      urine pregnancy test within 72 hours prior to start of trial medication.

      3. Not breast feeding at any time during the study.

   - Written and voluntary informed consent.

Exclusion Criteria:

   - Diagnosis of any of the following:

      1. Precursor T-cell lymphoma or leukemia

      2. Adult T-cell lymphoma/leukemia (ATLL)

      3. T-cell prolymphocytic leukemia

      4. T-cell large granular lymphocytic leukemia

      5. Primary cutaneous type anaplastic large cell lymphoma

      6. Mycosis fungoide/Sezary syndrome

   - Ongoing treatment with an anticancer agent not contemplated in this protocol.

   - Any history of clinically relevant coronary artery disease or myocardial infarction
   within the last 3 years.

   - Known central nervous system lymphoma.

   - Stem cell transplant less than 3 months prior to enrolment.

   - Non-tolerable > 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.

Ages Eligible for Study

18 Years - N/A

Genders Eligible for Study

All

Now accepting new patients

Contact Information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305
Luu Q. Pham
650-736-6432
Recruiting