Clinical trial · Interventional
Combination Chemotherapy and Tipifarnib in Treating Patients With Newly Diagnosed Acute Myeloid Leukemia
A Phase I Study of R115777 (Zarnestra) in Combination With Induction Chemotherapy in Patients With Newly Diagnosed, High Risk Acute Myeloid Leukemia
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Withdrawn due to "toxicity" problems
Summary
Brief summary (as posted)
RATIONALE: Drugs used in chemotherapy, such as cytarabine, daunorubicin, and etoposide, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Tipifarnib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Giving combination chemotherapy together with tipifarnib may kill more cancer cells. PURPOSE: This phase I trial is studying the side effects and best dose of tipifarnib when given together with combination chemotherapy in treating patients with newly diagnosed 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 (7)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| chemotherapy | Procedure | — | UNRESOLVED |
| cytarabine | Drug | Cytarabine | ALIAS |
| daunorubicin hydrochloride | Drug | Daunorubicin | ALIAS |
| enzyme inhibitor therapy | Procedure | — | UNRESOLVED |
| etoposide | Drug | Etoposide | ALIAS |
| high-dose chemotherapy | Procedure | — | UNRESOLVED |
| tipifarnib | Drug | Tipifarnib | ALIAS |
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 59 Years
Show eligibility criteria text
DISEASE CHARACTERISTICS: * Histologically or cytologically confirmed acute myeloid leukemia (AML) according to the WHO classification system * High-risk disease * Newly diagnosed disease * Patients with secondary AML due to prior chemotherapy for a different malignancy are eligible * No known inv(16), t(8;21), or t(15;17) cytogenetic abnormality * No acute promyelocytic leukemia * No CNS leukemia PATIENT CHARACTERISTICS: Age * 18 to 59 Performance status * ECOG 0-2 Life expectancy * More than 6 months Hematopoietic * Not specified Hepatic * AST and ALT ≤ 2.5 times upper limit of normal * Bilirubin normal Renal * Creatinine normal OR * Creatinine clearance ≥ 60 mL/min Cardiovascular * Ejection fraction \> 50% by echocardiogram or MUGA * No symptomatic congestive heart failure * No unstable angina pectoris * No cardiac arrhythmia Immunologic * No known HIV positivity * No history of allergic reactions attributed to compounds of similar chemical or biological composition to tipifarnib * No allergy to imidazoles (e.g., clotrimazole, ketoconazole, miconazole, or econazole) * No ongoing or active infection Other * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective contraception * No other uncontrolled illness * No psychiatric illness or social situation that would preclude study compliance PRIOR CONCURRENT THERAPY: Biologic therapy * No concurrent epoetin alfa Chemotherapy * See Disease Characteristics * No prior chemotherapy for AML or myelodysplastic syndromes except hydroxyurea Endocrine therapy * Not specified Radiotherapy * No concurrent palliative radiotherapy Surgery * Not specified Other * More than 30 days since prior investigational agents * No other concurrent investigational or commercial agents or therapies for the malignancy
References
Publications (0)
Data not yet available