Clinical Trials /

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

NCT02464228

Description:

This Phase II studyis designed to investigate the antitumor activity in terms of objective response rate (ORR) of tipifarnib in 18 subjects with advanced Peripheral T-Cell Lymphoma (PTCL). The total number of patients could be extended to 30 pending on the degree of response observed at an interim analysis. Tipifarnib will be administered until disease progression then followed approximately every 12 weeks for survival until either death or 12 months after accrual of the last study subject, whichever occurs first.

Related Conditions:
  • Anaplastic Large Cell Lymphoma
Recruiting Status:

Unknown status

Phase:

Phase 2

Trial Eligibility

Document

Title

  • Brief Title: Study of Tipifarnib in Subjects With Relapsed or Refractory Peripheral T-Cell Lymphoma
  • Official Title: An Open Label Phase II Study of Tipifarnib in Subjects With Relapsed or Refractory Peripheral T-Cell Lymphoma

Clinical Trial IDs

  • ORG STUDY ID: KO-TIP-002
  • NCT ID: NCT02464228

Conditions

  • Relapsed Peripheral T-Cell Lymphoma
  • Refractory Peripheral T-Cell Lymphoma

Interventions

DrugSynonymsArms
TipifarnibZarnestaTipifarnib

Purpose

This Phase II studyis designed to investigate the antitumor activity in terms of objective response rate (ORR) of tipifarnib in 18 subjects with advanced Peripheral T-Cell Lymphoma (PTCL). The total number of patients could be extended to 30 pending on the degree of response observed at an interim analysis. Tipifarnib will be administered until disease progression then followed approximately every 12 weeks for survival until either death or 12 months after accrual of the last study subject, whichever occurs first.

Detailed Description

      This Phase II study will investigate the antitumor activity in terms of ORR of tipifarnib in
      subjects with relapsed or refractory PTCL. Up to 30 subjects may be enrolled in the study.
      The first 18 subjects may be of the following PTCL sub-types: PTCL, not otherwise specified
      (PTCL-NOS), angioimmunoblastic T-cell lymphoma (AITL), ALK-positive and -negative anaplastic
      large cell lymphoma (ALCL), hepatosplenic T-cell lymphoma, enteropathy-associate T-cell
      lymphoma (EATL), extranodal natural killer (NK) T-cell lymphoma, nasal type and subcutaneous
      panniculitis-like T-cell lymphoma. The AITL expansion cohort (N=12) will enroll only subjects
      with AITL.

      A two-stage study design will be used for the first 18 subjects in order to minimize the
      number of study subjects treated if tipifarnib were considered not sufficiently efficacious
      to grant further development in this subject population. Tumor response assessments will be
      conducted according to IWC and/or mSWAT criteria.

      Tumor assessments will be performed approximately every 8 weeks on cycles 2-6 and at least
      once approximately every 12 weeks thereafter (Cycles 9, 12, 15, etc.), and will continue
      until disease progression. Subjects who have experienced a complete response may be
      considered for transplantation. Upon disease progression, all subjects will be followed
      approximately every 12 weeks for survival and the use of subsequent therapy until either
      death or 12 months after accrual of the last study subject, whichever occurs first. All
      subjects will be followed-up for safety during treatment and up to approximately 30 days (30
      +/- 7 days) after treatment discontinuation or until immediately before the initiation of
      another anti-cancer therapy, whichever occurs first. Additional follow up may be implemented
      until the subject recovers from any emergent treatment related toxicity or the adverse event
      is considered irreversible by the investigator.
    

Trial Arms

NameTypeDescriptionInterventions
TipifarnibExperimentaltipifarnib, oral
  • Tipifarnib

Eligibility Criteria

        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.
      
Maximum Eligible Age:N/A
Minimum Eligible Age:18 Years
Eligible Gender:All
Healthy Volunteers:No

Primary Outcome Measures

Measure:objective response rate (ORR)
Time Frame:2 years
Safety Issue:
Description:Response assessments according to IWC and/or mSWAT

Secondary Outcome Measures

Measure:Progression Free Survival
Time Frame:2 years
Safety Issue:
Description:
Measure:Duration of Response
Time Frame:1 year
Safety Issue:
Description:
Measure:Number of patients that experience Adverse Events (AEs)
Time Frame:Until 30 days following end of study
Safety Issue:
Description:

Details

Phase:Phase 2
Primary Purpose:Interventional
Overall Status:Recruiting
Lead Sponsor:Kura Oncology, Inc.

Trial Keywords

  • PTCL
  • Lymphoma
  • AITL

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