Clinical trial · Interventional
Tipifarnib in Treating Older Patients With Previously Untreated Acute Myeloid Leukemia
A Phase II Study of Farnesyl Transferase Inhibitor R115777 (Zarnestra) (R115777 ( Zarnestra), Tipifarnib, R115777, NSC #702818) in Elderly Patients With Previously Untreated Poor-Risk Acute Myeloid Leukemia
NCT00027872CI-TRIAL-00009809completedPhase 2ClinicalTrials.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)
Tipifarnib may stop the growth of cancer cells by blocking the enzymes necessary for their growth. Phase II trial to study the effectiveness of tipifarnib in treating older patients who have previously untreated acute myeloid leukemia
Conditions
Conditions (21)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Acute Myeloid Leukemia With Multilineage Dysplasia Following Myelodysplastic Syndrome | Acute Myeloid Leukemia Arising from Previous Myelodysplastic Syndrome | ALIAS | 0.90 |
| Adult Acute Basophilic Leukemia | Adult Acute Basophilic Leukemia | ONTOLOGY_EXACT | 0.98 |
| Adult Acute Eosinophilic Leukemia | — | UNRESOLVED | — |
| Adult Acute Erythroid Leukemia (M6) | Adult Acute Erythroid Leukemia | ONTOLOGY_EXACT | 0.85 |
| Adult Acute Megakaryoblastic Leukemia (M7) | Adult Acute Megakaryoblastic Leukemia | ONTOLOGY_EXACT | 0.85 |
| Adult Acute Minimally Differentiated Myeloid Leukemia (M0) | Adult Acute Myeloid Leukemia with Minimal Differentiation | ALIAS | 0.90 |
| Adult Acute Monoblastic Leukemia and Acute Monocytic Leukemia (M5) | Adult Acute Monoblastic and Monocytic Leukemia | ALIAS |
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 oral tipifarnib twice daily on days 1-21. Patients with a complete or partial response, hematologic improvement, or stable disease continue treatment every 29-63 days in the absence of disease progression or unacceptable toxicity. Patients with a complete response after the second course of therapy receive 2 additional courses of therapy.
- interventionNames
- Drug: tipifarnib
- Other: laboratory biomarker analysis
Primary outcomes (1)
- measure
- Complete remission (CR) rate
- timeFrame
- Up to 8 years
- description
- CR rates will be calculated with 95% confidence intervals for each age group separately.
Secondary outcomes (4)
- measure
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 65 Years
Show eligibility criteria text
Inclusion Criteria: * Pathologic confirmation of the diagnosis of AML (\>= 20% marrow blasts) * ECOG performance status 0 or 1 * Patients must be able to give informed consent * SGOT and SGPT =\< 2.5 x normal limits (grade 1) * Serum creatinine =\< 1.5 x normal limits (grade 1) * AML (any of the following): * Newly diagnosed AML in adults \>= 75 years * Newly diagnosed AML arising from MDS in adults \>= 65 years * Hyperleukocytosis with \>= 30,000 leukemic blasts/uL Exclusion Criteria: * Acute promyelocytic (FAB M3) subtype * Previously treated with chemotherapy for leukemia (except for hydroxyurea) * Disseminated intravascular coagulation (laboratory or clinical) * Active central nervous system leukemia * Concomitant radiation therapy, chemotherapy, or immunotherapy; previous therapy for another malignancy is permitted, provided that at least 1 month has occurred since patient received any of these treatments * Intrinsic impaired organ function (as stated above) * Symptomatic neuropathy (grade 2 or worse) * Known allergy to imidazole drugs, such as ketoconazole, miconazole, econazole, teconazole, clotrimazole, fenticonazole, isoconazole, sulconazole, or ticonazole * Physical or psychiatric conditions that in the estimation of the principal investigator (PI) or designee place the patient at high risk of toxicity or non-compliance, e.g. severe congestive heart failure (CHF), unstable angina, or poorly controlled psychosis
References
Publications (0)
Data not yet available
No reference posted for this study.