Investigation of Tipifarnib in Treatment of Subjects With Peripheral T-Cell Lymphoma (PTCL) That Have Not Responded to Standard Therapy

Completed · Phase 2

Conditions studied: Relapsed or Refractory Peripheral T-Cell Lymphoma

In brief

Phase II study designed to investigate antitumor activity in terms of objective response rate (ORR) of tipifarnib subjects with advanced Peripheral T-Cell Lymphoma (PTCL). Tipifarnib will be administered orally until disease progression.

Key facts

Study ID: NCT02464228
Run by: Kura Oncology, Inc.
People needed: 65
Starts: 2016-02-25
Expected to finish: 2021-03-31
Last updated by the study team: 2024-06-26

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

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:
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, not otherwise specified (NOS)
Subcutaneous panniculitis-like T-cell lymphoma
For enrollment into the AITL expansion cohort, subjects must have the diagnosis of AITL, nodal PTCL with T-follicular helper phenotype or follicular PTC.
For enrollment into the CXCL12+ PTCL expansion cohort, subjects must have the diagnosis of PTCL (a - h subtypes listed above, except AITL), consent to provide buccal swabs for CXCL12 SNP testing, and be found to be CXCL12+ based on testing by a Sponsor approved methodology.
Relapsed or are refractory to at least 1 prior systemic cytotoxic therapy. -Subjects must have received conventional therapy as a prior therapy.
Subject has consented to provide at least 6 unstained tumor slides (10 preferred) or an FFPE block for biomarker testing.
Subject has measurable disease as determined by the Lugano Classification and/or mSWAT.
At least 2 weeks since the last systemic therapy regimen prior to enrollment.
At least 2 weeks since last radiotherapy if radiation was localized to the only site of measurable disease, unless there is documentation of disease progression of the irradiated site. Subjects must have recovered from all acute toxicities from radiotherapy.
ECOG performance status of 0-2
Acceptable liver and renal function
Acceptable hematologic status
Female subjects must be either:
Of non-child-bearing potential (surgically sterilized or at least 2 years post- menopausal); or
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.
Not breast feeding at any time during the study.
Written and voluntary informed consent.

You may not qualify if…

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 this 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.
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.
Subjects who have exhibited allergic reactions to tipifarnib, or structural compounds similar to tipifarnib or to its excipients. This includes hypersensitivity to imidazoles, such as clotrimazole, ketoconazole, miconazole and others in this drug class.
Concomitant disease or condition that could interfere with the conduct of the study, or that would, in the opinion of the investigator, pose an unacceptable risk to the subject in this study.
The subject has legal incapacity or limited legal capacity.
Dementia or significantly altered mental status that would limit the understanding or rendering of informed consent and compliance with the requirements of this protocol.
Unwillingness or inability to comply with the study protocol for any reason.

Where it is running

Stanford University Medical Center — Palo Alto, California, United States
Yale University, Yale Cancer Center — New Haven, Connecticut, United States
H. Lee Moffitt Cancer Center & Research Institute, Inc. — Tampa, Florida, United States
Dana-Farber Cancer Institute — Boston, Massachusetts, United States
Mayo Clinic — Rochester, Minnesota, United States
Samsung Medical Center — Seoul, South Korea
Hospital Universitari Vall d'Hebron — Barcelona, Spain
Institut Catala d'Oncologia de Girona — Girona, Spain
MD Anderson Cancer Center Madrid — Madrid, Spain
Hospital Universitario 12 Octubre de Madrid — Madrid, Spain
Hospital Universitario de Salamanca — Salamanca, Spain
Hospital Universitario Virgen del Rocio — Seville, Spain
Hospital Clinico Universitario de Valencia — Valencia, Spain

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.