Tipifarnib in Treating Older Patients With Acute Myeloid Leukemia
Phase 2 Trial of R115777 in Previously Untreated Older Adults With AML and Baseline Presence of a Specific 2-Gene Expression Signature Ratio
8 other identifiers
interventional
21
1 country
7
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_2
Started May 2011
Typical duration for phase_2
7 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 1, 2011
CompletedFirst Submitted
Initial submission to the registry
May 24, 2011
CompletedFirst Posted
Study publicly available on registry
May 26, 2011
CompletedResults Posted
Study results publicly available
January 6, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
November 1, 2014
CompletedApril 8, 2015
February 1, 2015
3.5 years
May 24, 2011
November 15, 2013
March 19, 2015
Conditions
Outcome Measures
Primary Outcomes (1)
Complete Remission (CR) Rate
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.
From first treatment through follow up period, an expected average of 12 months
Secondary Outcomes (3)
Median Overall Survival (OS)
From first treatment through follow up period, an expected average of 12 months
Median 1-Year Survival Rate
1 year
Number of Participants With Relapse Free Survival
7 months
Study Arms (1)
Treatment (tipifarnib)
EXPERIMENTALPatients 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
Eligibility Criteria
You may qualify if:
- Previously untreated acute myeloid leukemia (AML) (de novo or secondary)
- No diagnosis of acute promyelocytic leukemia (APL)
- Deemed unsuitable for or refuses standard induction chemotherapy
- RASGRP1:APTX ratio \>= 5, through bone marrow screening
- No patients with known leukemic involvement of the central nervous system
- ECOG performance status =\< 2
- No WBC \>= 30,000/uL (hydroxyurea permitted up to 24 hours prior to initiation of therapy)
- Serum creatinine less than 1.5 times the upper limit of the normal range (ULN) (National Cancer Institute \[NCI\] Common Toxicity Criteria \[CTC\] Grade 1)
- Total bilirubin less than 1.5 times ULN (unless the increase is unequivocally due to hemolysis or Gilbert syndrome)
- ALT and AST less than 2.5 times ULN (NCI CTC Grade 1)
- Men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation
- No symptomatic neuropathy of grade 2 or worse
- No uncompensated disseminated intravascular coagulation (DIC) or uncontrolled bleeding
- No history of allergic reactions attributed to compounds of similar chemical or biologic composition to tipifarnib (R115777), such as the imidazole drugs, including clotrimazole, ketoconazole, miconazole, econazole, fenticonazole, isoconazole, sulconazole, ticonazole, or terconazole
- No uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements
- +5 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (7)
Moffitt Cancer Center
Tampa, Florida, 33612, United States
Emory University/Winship Cancer Institute
Atlanta, Georgia, 30322, United States
Blood and Marrow Transplant Group of Georgia
Atlanta, Georgia, 30342, United States
Johns Hopkins University/Sidney Kimmel Comprehensive Cancer Center
Baltimore, Maryland, 21287, United States
Memorial Sloan-Kettering Cancer Center
New York, New York, 10065, United States
Weill Medical College of Cornell University
New York, New York, 10065, United States
University of North Carolina
Chapel Hill, North Carolina, 27599, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Limitations and Caveats
Due to trial not meeting primary endpoint of at least 3 CR/CRi after 2 cycles, accrual was suspended. 1 year survival was not calculated, not relevant in the setting of a median survival of 6.6 months and with study not meeting its primary endpoint.
Results Point of Contact
- Title
- Jeffrey Lancet, M.D.
- Organization
- H. Lee Moffitt Cancer Center and Research Institute
Study Officials
- PRINCIPAL INVESTIGATOR
Jeffrey Lancet
Moffitt Cancer Center
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- LTE60
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- NIH
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 24, 2011
First Posted
May 26, 2011
Study Start
May 1, 2011
Primary Completion
November 1, 2014
Study Completion
November 1, 2014
Last Updated
April 8, 2015
Results First Posted
January 6, 2014
Record last verified: 2015-02