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.

An Open Label Phase II Study of Tipifarnib in Subjects with Relapsed or Refractory Peripheral T-Cell LymphomaLymphoma

Status

Not yet recruiting

Phases

Phase 2

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2016-001396-69-ES

Enrollment

Registered

2016-08-05

Start date

2016-10-27

Completion date

Unknown

Last updated

2016-10-31

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Subjects with Relapses and Refractory Peripheral T-Cell Lymphoma

Interventions

Product Name: Tipifarnib Product Code: R115777 Pharmaceutical Form: Film-coated tablet INN or Proposed INN: tipifarnib CAS Number: 192185-72-1 Current Sponsor code: R115777 Other descriptive name: TIP

Eligibility

Sex/Gender

All

Inclusion criteria

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

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 Page 6 of 58 f. Mycosis fungoide/Sezary syndrome

Design outcomes

Primary

Measure	Time frame
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	—

Measure

Time frame

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

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Secondary

Measure	Time frame
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	—

Measure

Time frame

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

—

Countries

Spain, United States

Contacts

Public ContactHead of Clinical Operations

Kura Oncology, Inc

karen@kuraoncology.com001617588-3747

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026