Clinical trial · Interventional
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
NCT01361464CI-TRIAL-00017434completedPhase 2Results postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (16)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Adult Acute Megakaryoblastic Leukemia | Adult Acute Megakaryoblastic Leukemia | ONTOLOGY_EXACT | 0.98 |
| Adult Acute Monoblastic Leukemia | Adult Acute Monoblastic Leukemia | ONTOLOGY_EXACT | 0.98 |
| Adult Acute Monocytic Leukemia | Adult Acute Monocytic Leukemia | ONTOLOGY_EXACT | 0.98 |
| Adult Acute Myeloid Leukemia With Inv(16)(p13.1q22); CBFB-MYH11 | Adult Acute Myeloid Leukemia with inv(16)(p13.1q22); CBFB-MYH11 | ONTOLOGY_EXACT | 0.98 |
| Adult Acute Myeloid Leukemia With Maturation | Adult Acute Myeloid Leukemia with Maturation | ONTOLOGY_EXACT | 0.98 |
| Adult Acute Myeloid Leukemia With Minimal Differentiation | Adult Acute Myeloid Leukemia with Minimal Differentiation | ONTOLOGY_EXACT | 0.98 |
| Adult Acute Myeloid Leukemia Without Maturation | Adult Acute Myeloid Leukemia without Maturation | ONTOLOGY_EXACT |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Laboratory Biomarker Analysis | Other | — | UNRESOLVED |
| Tipifarnib | Drug | Tipifarnib | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Treatment (tipifarnib)
- description
- 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.
- interventionNames
- Drug: Tipifarnib
- Other: Laboratory Biomarker Analysis
Primary outcomes (1)
- measure
- Complete Remission (CR) Rate
- timeFrame
- From first treatment through follow up period, an expected average of 12 months
- description
- 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.
Secondary outcomes (3)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 65 Years
Show eligibility criteria text
Inclusion Criteria: * 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 * Known HIV-positive patients on combination antiretroviral therapy are ineligible because of the potential for pharmacokinetic interactions with R115777; in addition, these patients are at increased risk of lethal infections when treated with marrow-suppressive therapy; known HIV-positive patients NOT on antiretroviral therapy AND with a CD4 cell count \>= 400/mm\^3 are eligible * No other concurrent cytotoxic or biologic antileukemic therapy * No patients who are receiving any other investigational agents * Use of enzyme-inducing anticonvulsants (e.g., phenytoin, fosphenytoin, phenobarbital, primidone, carbamazepine, oxcarbazepine) while taking tipifarnib (R115777) is contraindicated * If clinically indicated, subjects may use non-enzyme-inducing anticonvulsants during treatment with R115777
References
Publications (0)
Data not yet available
No reference posted for this study.