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

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ClinicalTrials.gov Identifier: NCT02464228
Recruitment Status : Recruiting
First Posted : June 8, 2015
Last Update Posted : October 12, 2017
Sponsor:
Information provided by (Responsible Party):
Kura Oncology, Inc.

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Relapsed Peripheral T-Cell Lymphoma Refractory Peripheral T-Cell Lymphoma Drug: Tipifarnib Phase 2

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.


Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: An Open Label Phase II Study of Tipifarnib in Subjects With Relapsed or Refractory Peripheral T-Cell Lymphoma
Study Start Date : September 2015
Estimated Primary Completion Date : December 2018
Estimated Study Completion Date : December 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lymphoma

Arm Intervention/treatment
Experimental: Tipifarnib
tipifarnib, oral
Drug: Tipifarnib
oral
Other Name: Zarnesta




Primary Outcome Measures :
  1. objective response rate (ORR) [ Time Frame: 2 years ]
    Response assessments according to IWC and/or mSWAT


Secondary Outcome Measures :
  1. Progression Free Survival [ Time Frame: 2 years ]
  2. Duration of Response [ Time Frame: 1 year ]
  3. Number of patients that experience Adverse Events (AEs) [ Time Frame: Until 30 days following end of study ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02464228


Contacts
Contact: Karen Bracken 617-588-3760 medicalaffairs@kuraoncology.com

Locations
United States, California
Stanford University Medical Center Recruiting
Palo Alto, California, United States
United States, Connecticut
Yale University, Yale Cancer Center Not yet recruiting
New Haven, Connecticut, United States, 06520
United States, Florida
H. Lee Moffitt Cancer Center & Research Institute, Inc. Recruiting
Tampa, Florida, United States, 33612
United States, Massachusetts
Dana-Farber Cancer Institute Recruiting
Boston, Massachusetts, United States, 02215
United States, Minnesota
Mayo Clinic Recruiting
Rochester, Minnesota, United States
Spain
Hospital Universitari Vall d'Hebron Not yet recruiting
Barcelona, Spain, 08035
Catalonian Institute of Oncology Not yet recruiting
Barcelona, Spain
MD Anderson Cancer Center Madrid Not yet recruiting
Madrid, Spain, 28033
Hospital 12 Octubre de Madrid Not yet recruiting
Madrid, Spain, 28041
Hospital Universitario de Salamanca Not yet recruiting
Salamanca, Spain, 37007
Hospital Virgen del Rocio Not yet recruiting
Sevilla, Spain, 41013
Hospital Clinico Universitario de Valencia Not yet recruiting
Valencia, Spain, 46010
Hospital Clinico Universitario de Valencia Not yet recruiting
Valencia, Spain
Sponsors and Collaborators
Kura Oncology, Inc.

Responsible Party: Kura Oncology, Inc.
ClinicalTrials.gov Identifier: NCT02464228     History of Changes
Other Study ID Numbers: KO-TIP-002
First Posted: June 8, 2015    Key Record Dates
Last Update Posted: October 12, 2017
Last Verified: October 2017

Keywords provided by Kura Oncology, Inc.:
PTCL
Lymphoma
AITL

Additional relevant MeSH terms:
Tipifarnib
Lymphoma
Lymphoma, T-Cell
Lymphoma, T-Cell, Peripheral
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Lymphoma, Non-Hodgkin
Antineoplastic Agents