drugset / Trial / NCT02299518

Selinexor and Chemotherapy in Treating Patients With Relapsed or Refractory Acute Myeloid Leukemia

NCT02299518

Phase 1 Completed 23 enrolled Alice Mims Karyopharm Therapeutics Inc · collab
Non-randomizedParallel-groupOpen-labelTreatment

Summary

This phase I trial studies the side effects and best dose of selinexor when given together with etoposide with or without mitoxantrone hydrochloride and cytarabine in treating patients with acute myeloid leukemia that has returned (relapsed) or has not responded to treatment (refractory). Selinexor may help stop the growth of tumor cells by blocking an enzyme needed for cancer cell growth. Drugs used in chemotherapy, such as etoposide, mitoxantrone hydrochloride, and cytarabine, work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving chemotherapy together with selinexor work better in treating relapsed or refractory acute myeloid leukemia.

Timeline

Start
2015-05-18
Primary completion
2018-03-06
Completion
2018-03-06

Drugs

EvaluationDrugModalityDoseRoute
Subject Etoposide Small molecule Intravenous
Subject Selinexor Other / unclassified 30 mg/m2 Oral
Subject Selinexor Other / unclassified 40 mg/m2 Oral
Background Cytarabine Small molecule Intravenous
Background Mitoxantrone Small molecule