Clinical trial · Interventional
Tipifarnib, Cytarabine, and Daunorubicin in Treating Older Patients With Acute Myeloid Leukemia
A Phase I Study Of Therapy With The Farnesyl Transferase Inhibitor R115777 (Zarnestra) Combined With Conventional Induction And Consolidation Chemotherapy For Previously Untreated Patients Over Age 55 With Acute Myeloid Leukemia (AML)
- 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)
RATIONALE: Tipifarnib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy, such as cytarabine and daunorubicin, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Giving tipifarnib together with cytarabine and daunorubicin may kill more cancer cells. PURPOSE: This phase I trial is studying the side effects and best dose of tipifarnib when given with cytarabine and daunorubicin in treating older patients with acute myeloid leukemia.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Leukemia | Leukemia | ONTOLOGY_EXACT | 0.90 |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| cytarabine | Drug | Cytarabine | ALIAS |
| daunorubicin hydrochloride | Drug | Daunorubicin | ALIAS |
| tipifarnib | Drug | Tipifarnib | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Tipifarnib with conventional induction and consolidation
- interventionNames
- Drug: cytarabine
- Drug: daunorubicin hydrochloride
- Drug: tipifarnib
Primary outcomes (3)
- measure
- Maximum tolerated dose of tipifarnib when administered with cytarabine and daunorubicin
- timeFrame
- minimum of 30 days per treatment cycle
- measure
- Toxicity
- timeFrame
- All cycles
- measure
- Pharmacokinetics
- timeFrame
- Day 6
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 56 Years
Show eligibility criteria text
DISEASE CHARACTERISTICS: * Diagnosis of acute myeloid leukemia (AML) * All subtypes, except acute promyelocytic leukemia, are allowed * At least 20% bone marrow or peripheral blood blasts OR biopsy-confirmed extramedullary disease * No cerebrospinal fluid involvement PATIENT CHARACTERISTICS: Age * 56 and over Performance status * ECOG 0-2 OR * Karnofsky 60-100% Life expectancy * Not specified Hematopoietic * See Disease Characteristics * WBC \< 100,000/mm\^3 (treatment with hydroxyurea allowed) Hepatic * Bilirubin ≤ 1.25 times upper limit of normal (ULN) * AST and ALT ≤ 2.0 times ULN Renal * Creatinine \< 1.7 mg/dL OR * Creatinine clearance ≥ 60 mL/min Cardiovascular * LVEF ≥ 50% * No symptomatic congestive heart failure * No unstable angina pectoris * No cardiac arrhythmia Immunologic * HIV negative * No history of allergic reaction attributed to compounds of similar chemical or biologic composition to tipifarnib or imidazole drugs (e.g., ketoconazole, clotrimazole, or miconazole) * No ongoing or active infection Other * Not pregnant * Fertile patients must use effective contraception * Able to swallow oral medications * No other uncontrolled illness * No psychiatric illness or social situation that would preclude study compliance PRIOR CONCURRENT THERAPY: Biologic therapy * Not specified Chemotherapy * No prior chemotherapy for AML except hydroxyurea for cytoreduction * More than 4 weeks since prior chemotherapy except hydroxyurea (6 weeks for nitrosoureas or mitomycin) and recovered * At least 24 hours since prior hydroxyurea Endocrine therapy * No concurrent dexamethasone Radiotherapy * More than 4 weeks since prior radiotherapy and recovered * No prior radiotherapy \> 3,000 cGy to marrow-producing areas Surgery * Not specified Other * No other concurrent investigational agents * No other concurrent antileukemic agents * No concurrent treatment with any of the following: * Ketoconazole * Itraconazole * Voriconazole * Clarithromycin * Erythromycin * Phenytoin * Carbamazepine * Barbiturates * Cyclosporine * Pimozide * Warfarin * Grapefruit juice * Simvastatin * Lovastatin * Atorvastatin * No concurrent magnesium- or aluminum-containing antacids within 2 hours before or after tipifarnib administration
References
Publications (1)
- RESULTBrandwein JM, Leber BF, Howson-Jan K, Schimmer AD, Schuh AC, Gupta V, Yee KW, Wright J, Moore M, MacAlpine K, Minden MD; NCI CTEP Protocol 6670. A phase I study of tipifarnib combined with conventional induction and consolidation therapy for previously untreated patients with acute myeloid leukemia aged 60 years and over. Leukemia. 2009 Apr;23(4):631-4. doi: 10.1038/leu.2008.341. Epub 2008 Dec 18. PMID 19092853