Tipifarnib in Treating Older Patients With Acute Myeloid Leukemia
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ClinicalTrials.gov Identifier: NCT01361464 |
Recruitment Status
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Completed
First Posted
: May 26, 2011
Results First Posted
: January 6, 2014
Last Update Posted
: April 8, 2015
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Tracking Information | ||||
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First Submitted Date ICMJE | May 24, 2011 | |||
First Posted Date ICMJE | May 26, 2011 | |||
Results First Submitted Date | November 15, 2013 | |||
Results First Posted Date | January 6, 2014 | |||
Last Update Posted Date | April 8, 2015 | |||
Study Start Date ICMJE | May 2011 | |||
Actual Primary Completion Date | November 2014 (Final data collection date for primary outcome measure) | |||
Current Primary Outcome Measures ICMJE |
Complete Remission (CR) Rate [ Time Frame: From first treatment through follow up period, an expected average of 12 months ] Complete Remission (CR) rate in Acute Myelogenous Leukemia (AML) patients prospectively selected for R115777R115777 (ZARNESTRA) treatment on the basis of a 2-gene signature (RASGRP1:APTX ratio) in bone marrow aspirates. AML Complete Remission: Bone marrow aspiration - Less than 5% leukemic blasts, Auer rods not detected; Peripheral blood counts - Absolute neutrophil count >/= 1,000/mm^3, Platelet count >/= 100,000/mm^3, Leukemic blasts not present; Blood-product transfusion independence; Absence of extramedullary leukemia.
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Original Primary Outcome Measures ICMJE |
Number of Participants with Complete Remission [ Time Frame: From first treatment through follow up period, an expected average of 12 months ] To determine the complete remission (CR) rate in AML patients prospectively selected for R115777R115777 (ZARNESTRA) treatment on the basis of a 2-gene signature (RASGRP1:APTX ratio) in bone marrow aspirates. Patients will be periodically followed after their completion of the study to collect information on subsequent therapies and survival data.
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Change History | Complete list of historical versions of study NCT01361464 on ClinicalTrials.gov Archive Site | |||
Current Secondary Outcome Measures ICMJE |
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Original Secondary Outcome Measures ICMJE |
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Current Other Outcome Measures ICMJE | Not Provided | |||
Original Other Outcome Measures ICMJE | Not Provided | |||
Descriptive Information | ||||
Brief Title ICMJE | Tipifarnib in Treating Older Patients With Acute Myeloid Leukemia | |||
Official Title ICMJE | Phase 2 Trial of R115777 in Previously Untreated Older Adults With AML and Baseline Presence of a Specific 2-Gene Expression Signature Ratio | |||
Brief Summary | This phase II trial is studying how well tipifarnib works in treating older patients with acute myeloid leukemia. Tipifarnib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. | |||
Detailed Description | PRIMARY OBJECTIVES: I. To determine the complete remission (CR) rate in acute myeloid leukemia (AML) patients prospectively selected for tipifarnib (ZARNESTRA) treatment on the basis of a 2-gene signature (RASGRP1:APTX ratio) in bone marrow aspirates. SECONDARY OBJECTIVES: I. To determine the median overall and 1-year survival of patients treated with this regimen II. To determine the median relapse-free survival of patients treated with this regimen. III. To determine the safety of this regimen in these patients IV. To determine the immunophenotypic expression of RASGRP1 on baseline bone marrow blasts and assess correlation with PCR-based detection. OUTLINE: This is a multicenter study. Patients receive tipifarnib orally twice daily on days 1-21. Treatment repeats every 28 days for up to 6 courses in the absence of disease progression or unacceptable toxicity. Bone marrow aspirate and/or biopsy are collected at baseline and on day 28 of course 1 and 2 for RasGRP1 protein expression analysis by qRT-PCR. After completion of study therapy, patients are followed up every 30 days. |
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Study Type ICMJE | Interventional | |||
Study Phase | Phase 2 | |||
Study Design ICMJE | Intervention Model: Single Group Assignment Masking: None (Open Label) Primary Purpose: Treatment |
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Condition ICMJE |
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Intervention ICMJE |
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Study Arms | Experimental: Treatment (tipifarnib)
Patients receive tipifarnib orally twice daily on days 1-21. Treatment repeats every 28 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.
Interventions:
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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 | Completed | |||
Actual Enrollment ICMJE |
21 | |||
Original Estimated Enrollment ICMJE |
35 | |||
Actual Study Completion Date | November 2014 | |||
Actual Primary Completion Date | November 2014 (Final data collection date for primary outcome measure) | |||
Eligibility Criteria ICMJE | Inclusion Criteria:
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Sex/Gender |
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Ages | 65 Years and older (Adult, Senior) | |||
Accepts Healthy Volunteers | 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 | NCT01361464 | |||
Other Study ID Numbers ICMJE | NCI-2011-02589 NCI-2011-02589 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) ) 16572 CDR0000699713 8977 ( Other Identifier: Moffitt Cancer Center ) 8977 ( Other Identifier: CTEP ) P30CA076292 ( U.S. NIH Grant/Contract ) N01CM00071 ( U.S. NIH Grant/Contract ) U01CA070095 ( U.S. NIH Grant/Contract ) N01CM00100 ( U.S. NIH Grant/Contract ) |
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Has Data Monitoring Committee | Not Provided | |||
U.S. FDA-regulated Product | Not Provided | |||
IPD Sharing Statement | Not Provided | |||
Responsible Party | National Cancer Institute (NCI) | |||
Study Sponsor ICMJE | National Cancer Institute (NCI) | |||
Collaborators ICMJE | Not Provided | |||
Investigators ICMJE |
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PRS Account | National Cancer Institute (NCI) | |||
Verification Date | February 2015 | |||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |