drugset / Trial / NCT00093600

PKC412, Daunorubicin, and Cytarabine in Treating Patients With Newly Diagnosed Acute Myeloid Leukemia

NCT00093600

Phase 1 Completed 69 enrolled Novartis Pharmaceuticals
Non-randomizedParallel-groupOpen-labelTreatment

Summary

RATIONALE: PKC412 may stop the growth of cancer cells by blocking the enzymes necessary for their growth. It may also increase the effectiveness of daunorubicin and cytarabine by making cancer cells more sensitive to the drugs. Drugs used in chemotherapy, such as daunorubicin and cytarabine, work in different ways to stop cancer cells from dividing so they stop growing or die. Combining PKC412 with chemotherapy may kill more cancer cells. PURPOSE: This phase I trial is studying the side effects and best way to give PKC412 when given either after or together with daunorubicin and cytarabine in treating patients with newly diagnosed acute myeloid leukemia.

Timeline

Start
2004-02
Primary completion
2011-06
Completion
2011-06

Drugs

EvaluationDrugModalityDoseRoute
Subject Midostaurin Small molecule 50 mg Oral
Subject Midostaurin Small molecule 100 mg Oral
Background Cytarabine Small molecule Intravenous
Background Daunorubicin Small molecule Intravenous