NCT02779777

Tipifarnib in Subjects With Myelodysplastic Syndromes

An Adaptive Phase 2 Study of Tipifarnib in Subjects With Myelodysplastic Syndromes

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 16 (actual)
• Sponsor: Kura Oncology, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is a Phase 2 randomized, open-label, two-stage study designed to investigate the antitumor activity of tipifarnib in approximately 36 eligible subjects with MDS who have no known curative treatment. Subjects will be randomized to receive tipifarnib orally with food according to one of 2 treatment regimens.

Detailed description

This Phase 2 study will investigate the antitumor activity in terms of ORR of tipifarnib in approximately 36 eligible subjects with MDS who have no known curative treatment. Eligible subjects may have received no more than 2 prior systemic regimens. Subjects will be randomized to receive tipifarnib orally with food according to one of 2 dose regimens. In the absence of unmanageable toxicities, subjects may continue to receive tipifarnib treatment until disease progression. Disease assessments will be performed at screening and at least once every approximately 12 weeks starting at the end of cycle 3. Determination of ORR will be assessed by the Investigator according to the MDS International Working Group (IWG) criteria (Cheson 2006). Upon disease progression, all subjects in the study 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 study has been completed, whichever occurs first.

Conditions

• Myelodysplastic Syndromes

Interventions

Type	Name	Description
DRUG	Tipifarnib	Oral tablet

Timeline

• Start date: 2016-06-01
• Primary completion: 2018-08-28
• Completion: 2018-08-28
• First posted: 2016-05-20
• Last updated: 2024-07-31
• Results posted: 2024-07-31

Locations

2 sites across 1 country: United States