drugset / Trial / NCT01093573

Midostaurin and Azacitidine in Treating Elderly Patients With Acute Myelogenous Leukemia

NCT01093573

Non-randomizedSequentialOpen-labelTreatment

Summary

RATIONALE: Midostaurin may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy, such as azacitidine, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Midostaurin may help azacitidine kill more cancer cells by making the cancer cells more sensitive to the drug. PURPOSE: This phase I/II trial is studying the side effects and best dose of midostaurin when given together with azacitidine and to see how well it works in treating elderly patients with acute myelogenous leukemia.

Timeline

Start
2009-07
Primary completion
2016-09-08
Completion
2017-05-05

Drugs

EvaluationDrugModalityDoseRoute
Subject Midostaurin Small molecule 25 mg Oral
Subject Midostaurin Small molecule 50 mg Oral
Subject Midostaurin Small molecule 75 mg Oral
Background Azacitidine Other / unclassified 75 mg/m2 Intravenous