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Investigation of Tipifarnib in Treatment of Subjects With PTCL That Have Not Responded to Standard Therapy.
Trial ID: NCT02464228
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.
An Open Label Phase II Study of Tipifarnib in Subjects With Relapsed or Refractory Peripheral T-Cell Lymphoma
Saul A. Rosenberg, MD, Professor of Lymphoma
Clinical Associate Professor, Medicine - Oncology
Hans-Christoph Becker, MD, FSABI, FSCCT
Clinical Professor, Radiology
Neel K. Gupta
Clinical Assistant Professor, Medicine - Oncology Clinical Assistant Professor, Medicine - Hematology
1. Diagnosis of PTCL according to the most recent edition of the World Health
Organization (WHO) Classification of Tumors of Hematopoietic or Lymphoid Tissues, as
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, not otherwise specified (NOS)
8. Subcutaneous panniculitis-like T-cell lymphoma
2. For enrollment into the AITL expansion cohort, subjects must have the diagnosis of
AITL, nodal PTCL with T-follicular helper phenotype or follicular PTC.
3. 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.
4. Relapsed or are refractory to at least 1 prior systemic cytotoxic therapy. -Subjects
must have received conventional therapy as a prior therapy.
5. Subject has consented to provide at least 6 unstained tumor slides (10 preferred) or
an FFPE block for biomarker testing.
6. Subject has measurable disease as determined by the Lugano Classification and/or
7. At least 2 weeks since the last systemic therapy regimen prior to enrollment.
8. 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
9. ECOG performance status of 0-2
10. Acceptable liver and renal function
11. Acceptable hematologic status
12. Female subjects must be either:
1. Of non-child-bearing potential (surgically sterilized or at least 2 years post-
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.
13. Written and voluntary informed consent.
1. 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
2. Ongoing treatment with an anticancer agent not contemplated in this protocol.
3. Prior treatment (at least 1 full treatment cycle) with an FTase inhibitor.
4. Any history of clinically relevant coronary artery disease or myocardial infarction
within the last 3 years.
5. Known central nervous system lymphoma.
6. Stem cell transplant less than 3 months prior to enrolment.
7. Non-tolerable > Grade 2 neuropathy or evidence of unstable neurological symptoms
within 4 weeks of Cycle 1 Day 1.
8. Major surgery, other than diagnostic surgery, within 2 weeks prior to Cycle 1 Day 1,
without complete recovery.
9. Other active malignancy requiring therapy such as radiation, chemotherapy, or
10. Active, uncontrolled bacterial, viral, or fungal infections, requiring systemic
Known infection with HIV, or an active infection with hepatitis B or hepatitis C.
11. 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
12. 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.
13. The subject has legal incapacity or limited legal capacity.
14. Dementia or significantly altered mental status that would limit the understanding or
rendering of informed consent and compliance with the requirements of this protocol.
15. Unwillingness or inability to comply with the study protocol for any reason.
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