Selinexor (KPT-330) in Older Patients With Relapsed AM

Phase 1

• Conditions: Acute Myeloid Leukemia (AML); MedDRA version: 17.0Level: LLTClassification code 10000886Term: Acute myeloid leukemiaSystem Organ Class: 100000004864; Therapeutic area: Diseases [C] - Cancer [C04]

• Registration Number: EUCTR2014-000920-26-ES
• Lead Sponsor: Karyopharm Therapeutics, Inc.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2014-05-23
• Last Update Posted: 5 February 2018

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 150

Inclusion Criteria

Patients age older or equal 60 years with relapsed/refractory AML (defined using WHO criteria) of any type except for AML M3, after one prior therapy only, who have never undergone, and who are not currently eligible for, stem cell transplantation and are currently deemed unfit for intensive chemotherapy.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 40
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 110

Exclusion Criteria

Patients with acute promyelocytic leukemia (AML M3), known central nervous system (CNS) leukemia, or who are in blast transformation of chronic myeloid leukemia (CML) will be excluded from this study.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified