drugset
drugset / Trial / NCT01174888

Phase I Combination of Midostaurin, Bortezomib, and Chemo in Relapsed/Refractory Acute Myeloid Leukemia

NCT01174888 ↗

Phase 1 Completed 34 enrolled Alison Walker Millennium Pharmaceuticals, Inc. · collabNovartis · collab
Non-randomizedSingle-groupOpen-labelTreatment

Summary

RATIONALE: Bortezomib and midostaurin may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy, such as mitoxantrone hydrochloride, etoposide, and cytarabine, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Giving bortezomib and midostaurin together with combination chemotherapy may kill more cancer cells. PURPOSE: This phase I trial is studying the side effects and best dose of bortezomib when given together with midostaurin with or without combination chemotherapy in treating patients with relapsed or refractory acute myeloid leukemia.

Timeline

Start
2010-08
Primary completion
2014-04
Completion
2016-05

Publications

Drugs

EvaluationDrugModalityDoseRoute
Subject Bortezomib Small molecule 1 mg/m2 Intravenous
Subject Bortezomib Small molecule 1.3 mg/m2 Intravenous
Subject Midostaurin Small molecule 50 mg Oral
Background Cytarabine Small molecule — Intravenous
Background Etoposide Small molecule — Intravenous
Background Mitoxantrone Small molecule — Intravenous

Indications

acute myeloid leukemia with 11q23 abnormalities acute myeloid leukemia with multilineage dysplasia acute myeloid leukemia with t(8;21)(q22;q22) translocation acute myeloid leukemia, del(5q31-q32) acute myeloid leukemia, inv(16)(p13.1;q22) acute myeloid leukemia, t(16;16)(p13.1;q22) acute promyelocytic leukemia myelodysplastic syndrome