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A Study of Selinexor in Combination With Daunorubicin and Cytarabine for Untreated AML

NCT02403310 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 21

Last updated 2022-10-03

No results posted yet for this study

Summary

The main purpose of this study is to determine the safety of combining selinexor with daunorubicin and cytarabine. The maximal tolerated dose (MTD) of selinexor with daunorubicin and cytarabine will also be established.

Conditions

Interventions

DRUG

Selinexor

Induction: Oral selinexor on days 1, 3, 8, 10, 15 and 17. * Dose Level 2: 80 mg twice weekly. * Dose Level 1 (starting dose): 60 mg twice weekly. * Dose Level -1: 40 mg twice weekly. Consolidation: Selinexor same dose as induction (days 1,3,8,10) unless dose limiting toxicity (DLT) dictates a dose reduction. Maintenance: Selinexor at the same dose as induction on days 1 and 8 a 21 day cycle. They will continue for a maximum of 12 months.

DRUG

Daunorubicin

Induction: Daunorubicin 60 mg/m\^2/day (days 1-3). Consolidation: Daunorubicin 45 mg/m\^2/day (days 1-2).

DRUG

Cytarabine

Induction: Cytarabine 100 mg/m\^2/day (days 1-7). Consolidation: Cytarabine 100 mg/m\^2/day (continuous infusion on days 1-5).

Sponsors & Collaborators

  • Karyopharm Therapeutics Inc

    collaborator INDUSTRY

  • H. Lee Moffitt Cancer Center and Research Institute

    lead OTHER

Principal Investigators

  • Kendra Sweet, M.D. · H. Lee Moffitt Cancer Center and Research Institute

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-06-18
Primary Completion
2016-09-13
Completion
2021-02-01
FDA Drug
Yes

Countries

  • United States

Study Locations

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Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02403310 on ClinicalTrials.gov