A research study to find out whether tipifarnib is safe and effective for the treatment of a lymphoma in the cases of previous treatment have failed.

Phase 1

• Conditions: Subjects with Relapses and Refractory Peripheral T-Cell Lymphoma; Therapeutic area: Diseases [C] - Cancer [C04]

• Registration Number: EUCTR2016-001396-69-ES
• Lead Sponsor: Kura Oncology Inc.,

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2016-08-05
• Last Update Posted: 31 October 2016

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

Subject has a 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:
a. Anaplastic large cell lymphoma (ALCL), ALK positive
b. ALCL, ALK negative
c. Angioimmunoblastic T-cell lymphoma (AITL)
d. Enteropathy-associated T-cell lymphoma
e. Extranodal natural killer (NK) T-cell lymphoma, nasal type
f. Hepatosplenic T-cell lymphoma
g. Peripheral T-cell lymphoma, no otherwise specified (NOS)
h. Subcutaneous panniculitis-like T-cell lymphoma
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 25
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 5

Exclusion Criteria

1. Diagnosis of any of the following:
a. Precursor T-cell lymphoma or leukemia b. Adult T-cell lymphoma/leukemia (ATLL)
c. T-cell prolymphocytic leukemia
d. T-cell large granular lymphocytic leukemia
e. Primary cutaneous type anaplastic large cell lymphoma
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f. Mycosis fungoide/Sezary syndrome

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To determine the anti tumor activity in terms of objective response rate (ORR) of tipifarnib in subjects with relapsed or refractory peripheral T-cell Lymphoma (PTCL);Secondary Objective: To determine the anti tumor activity in terms of progression free survival ( PFS) and duration of response (DOR) of tipifarnib in subjects with relapsed or refractory PTCL;Primary end point(s): Response assessments determined by IWC and/or mSWAT;Timepoint(s) of evaluation of this end point: At screening (4 weeks before the first study drug administration), at the end of cycle 2, 4, 6 and then approximately 9 week cycle 9, 12, 15, and other thereafter until disease progression

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): SAEs evaluated according to NCI CTCAE v.4.03;Timepoint(s) of evaluation of this end point: Comprehensive assessment of any apparent toxicity experienced by the subject will be performed throughout the course of the trial (at each study visit and as clinically needed), from the time of the subject's signature of informed consent until 30 days from the final administration of the trial treatment or immediately before initiation of any other anticancer therapy, whichever comes first