Tipifarnib in Subjects With Myelodysplastic Syndromes
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ClinicalTrials.gov Identifier: NCT02779777 |
Recruitment Status :
Terminated
(Lack of efficacy)
First Posted : May 20, 2016
Last Update Posted : February 5, 2020
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Tracking Information | |||
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First Submitted Date ICMJE | May 10, 2016 | ||
First Posted Date ICMJE | May 20, 2016 | ||
Last Update Posted Date | February 5, 2020 | ||
Actual Study Start Date ICMJE | May 2016 | ||
Actual Primary Completion Date | December 2019 (Final data collection date for primary outcome measure) | ||
Current Primary Outcome Measures ICMJE |
Number of patients with red blood cell (RBC) transfusion independence (TI), in RBC transfusion-dependent subjects with very low, low or intermediate (INT) risk myelodysplastic syndromes (MDS) following treatment with tipfarnib. [ Time Frame: 1 year ] | ||
Original Primary Outcome Measures ICMJE | Same as current | ||
Change History | |||
Current Secondary Outcome Measures ICMJE |
The number of patients with positive or negative killer cell immunoglobulin-like receptor (KIR) 2DS2 and KIR2DL2 genotype status following treatment with tipifarnib. [ Time Frame: 1 year ] | ||
Original Secondary Outcome Measures ICMJE | Same as current | ||
Current Other Pre-specified Outcome Measures | Not Provided | ||
Original Other Pre-specified Outcome Measures | Not Provided | ||
Descriptive Information | |||
Brief Title ICMJE | Tipifarnib in Subjects With Myelodysplastic Syndromes | ||
Official Title ICMJE | An Adaptive Phase 2 Study of Tipifarnib in Subjects With Transfusion-dependent, Very Low, Low, or Intermediate Risk Myelodysplastic Syndromes | ||
Brief Summary | This 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. |
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Study Type ICMJE | Interventional | ||
Study Phase ICMJE | Phase 2 | ||
Study Design ICMJE | Allocation: N/A Intervention Model: Single Group Assignment Masking: None (Open Label) Primary Purpose: Treatment |
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Condition ICMJE | Myelodysplastic Syndromes | ||
Intervention ICMJE | Drug: Tipifarnib
900 mg b.i.d. Days 1 -7, 15-21 in 28-day cycle
Other Name: Zarnesta
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Study Arms ICMJE | Experimental: Tipifarnib, Oral
900 mg b.i.d. Days 1 -7, 15-21 in 28-day cycle
Intervention: Drug: Tipifarnib
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Publications * | Not Provided | ||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |||
Recruitment Status ICMJE | Terminated | ||
Actual Enrollment ICMJE |
16 | ||
Original Estimated Enrollment ICMJE |
58 | ||
Actual Study Completion Date ICMJE | January 24, 2020 | ||
Actual Primary Completion Date | December 2019 (Final data collection date for primary outcome measure) | ||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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Sex/Gender ICMJE |
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Ages ICMJE | 18 Years and older (Adult, Older Adult) | ||
Accepts Healthy Volunteers ICMJE | No | ||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||
Listed Location Countries ICMJE | United States | ||
Removed Location Countries | |||
Administrative Information | |||
NCT Number ICMJE | NCT02779777 | ||
Other Study ID Numbers ICMJE | KO-TIP-003 | ||
Has Data Monitoring Committee | Yes | ||
U.S. FDA-regulated Product | Not Provided | ||
IPD Sharing Statement ICMJE |
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Current Responsible Party | Kura Oncology, Inc. | ||
Original Responsible Party | Same as current | ||
Current Study Sponsor ICMJE | Kura Oncology, Inc. | ||
Original Study Sponsor ICMJE | Same as current | ||
Collaborators ICMJE | Not Provided | ||
Investigators ICMJE | Not Provided | ||
PRS Account | Kura Oncology, Inc. | ||
Verification Date | January 2020 | ||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |