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:

Recruiting

Phase:

Phase 2

Trial Eligibility

Document

Study of <span class="go-doc-concept go-doc-intervention">Tipifarnib</span> in Subjects With Relapsed or Refractory Peripheral T-Cell Lymphoma

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

    NCT ID: NCT02464228

    ORG ID: KO-TIP-002

    Trial Conditions

    Relapsed Peripheral T-Cell Lymphoma

    Refractory Peripheral T-Cell Lymphoma

    Trial Interventions

    Drug Synonyms Arms
    Tipifarnib Zarnesta Tipifarnib

    Trial 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. A
    two-stage study design will be used 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.

    Tipifarnib will be administered po, bid daily for 21 day followed by 1 week of rest in
    28-day cycles. In the absence of emerging unmanageable toxicity, subjects may continue
    tipifarnib treatment for as long as the investigator considers that the treatment is
    providing clinical benefit up to 12 months since the subject's enrolment. Treatment may
    continue beyond 12 months upon agreement by the Investigator and Sponsor if there is
    documented evidence of sustained clinical benefit.

    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

    Name Type Description Interventions
    Tipifarnib Experimental po, twice daily for 21 days followed by 1 week of rest in 28-day treatment cycles 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

    - 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.

    Minimum Eligible Age: 18 Years

    Maximum Eligible Age: N/A

    Eligible Gender: Both

    Primary Outcome Measures

    objective response rate (ORR)

    Secondary Outcome Measures

    Progression Free Survival

    Duration of Response

    Number of patients that experience Adverse Events (AEs)

    Trial Keywords

    PTCL

    Lymphoma