drugset
drugset / Trial / NCT00096122

Idarubicin, Cytarabine, and Tipifarnib in Treating Patients With Newly Diagnosed Myelodysplastic Syndromes or Acute Myeloid Leukemia

NCT00096122 ↗

Phase 1/2 Completed 95 enrolled National Cancer Institute (NCI)
NaSingle-groupOpen-labelTreatment

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.

Timeline

Start
2004-09
Primary completion
2006-09
Completion
2010-02

Drugs

EvaluationDrugModalityDoseRoute
Subject tipifarnib Small molecule — Oral
Background Cytarabine Small molecule — Intravenous
Background Idarubicin Small molecule — Intravenous

Indications

acute basophilic leukemia acute megakaryoblastic leukemia in adult acute myeloblastic leukemia with maturation acute myeloblastic leukemia without maturation acute myeloid leukemia with 11q23 abnormalities acute myeloid leukemia with minimal differentiation acute myeloid leukemia with t(8;21)(q22;q22) translocation acute myeloid leukemia, inv(16)(p13.1;q22) acute myeloid leukemia, t(16;16)(p13.1;q22) acute myelomonocytic leukemia M4 adult acute monocytic leukemia childhood myelodysplastic syndrome chronic myelomonocytic leukemia erythroleukemia myelodysplastic syndrome with excess blasts refractory anemia with excess blasts in transformation