CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 95 enrolled
Drug / intervention
cytarabine +2 moredrug
Likely dose
Idarubicin IV, cytarabine IV, and tipifarnib orally (specific doses not stated)AI-extracted
Key inclusion· 7
  • ✓AML with >20% blasts (WHO classification) or high-risk MDS with >10% blasts
  • ✓Chemotherapy-naïve (no prior chemotherapy except hydroxyurea)
  • ✓ECOG performance status 0-1
  • ✓Creatinine ≤2 mg/dL
Key exclusion· 4
  • ✕Acute promyelocytic leukemia (APL)
  • ✕Active systemic infection
  • ✕Coexisting medical condition likely to interfere with study procedures or results
  • ✕Known allergy to imidazole drugs (clotrimazole, ketoconazole, miconazole, econazole, fenticonazole, isoconazole, sulconazole, tioconazole, terconazole)

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00096122
NCT00096122Phase 2Completed
CompareCT.gov

PHASE I-II STUDY OF IDARUBICIN, CYTARABINE AND R115777 (TIPIFARNIB, ZARNESTRA; 702818; IND 58359), A FARNESYLTRANSFERASE INHIBITOR, IN PATIENTS WITH HIGH-RISK MYELODYSPLASTIC SYNDROMES AND ACUTE MYELOID LEUKEMIAS

National Cancer Institute (NCI)·interventional·Posted Nov 9, 2004·Updated May 26, 2014

In Brief

A Phase 2 clinical trial evaluating cytarabine, idarubicin, and 1 other intervention for Adult Acute Basophilic Leukemia and 22 related conditions. Completed, enrolled 95 participants across 1 site.

Detailed Summary

This phase I/II trial is studying the side effects and best dose of tipifarnib when given with idarubicin and cytarabine and to see how well it works in treating patients with newly diagnosed myelodysplastic syndromes or acute myeloid leukemia. Drugs used in chemotherapy, such as idarubicin and cytarabine, work in different ways to stop cancer cells from dividing so they stop growing or die. Tipifarnib (Zarnestra) may stop the growth of cancer cells by blocking the enzymes necessary for their growth. Giving idarubicin and cytarabine with tipifarnib may kill more cancer cells.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsAdult Acute Basophilic Leukemia, Adult Acute Eosinophilic Leukemia, Adult Acute Megakaryoblastic Leukemia (M7), Adult Acute Minimally Differentiated Myeloid Leukemia (M0), Adult Acute Monoblastic Leukemia (M5a), Adult Acute Monocytic Leukemia (M5b), Adult Acute Myeloblastic Leukemia With Maturation (M2), Adult Acute Myeloblastic Leukemia Without Maturation (M1), Adult Acute Myeloid Leukemia With 11q23 (MLL) Abnormalities, Adult Acute Myeloid Leukemia With Inv(16)(p13;q22), Adult Acute Myeloid Leukemia With t(16;16)(p13;q22), Adult Acute Myeloid Leukemia With t(8;21)(q22;q22), Adult Acute Myelomonocytic Leukemia (M4), Adult Erythroleukemia (M6a), Adult Pure Erythroid Leukemia (M6b), Childhood Myelodysplastic Syndromes, Chronic Myelomonocytic Leukemia, de Novo Myelodysplastic Syndromes, Refractory Anemia With Excess Blasts, Refractory Anemia With Excess Blasts in Transformation, Secondary Acute Myeloid Leukemia, Secondary Myelodysplastic Syndromes, Untreated Adult Acute Myeloid Leukemia
CountriesUnited States
Collaborators--

Timeline

Phase 2CompletedFinished
20052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedNov 9, 2004
Enrollment StartSep 1, 2004
Primary CompletionSep 1, 2006
Study CompletionFeb 1, 2010
TodayJul 2, 2026
Enrollment to primary: 2 yearsPosted 21.6 years ago

Interventions

cytarabinedrug

Given IV

idarubicindrug

Given IV

tipifarnibdrug

Given orally