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

Part of paid clinical trials in Tampa, Florida.

Sponsor
H. Lee Moffitt Cancer Center and Research Institute
Study ID
NCT02403310
Phase
PHASE1
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Selinexor — DRUG
    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.
  • Daunorubicin — DRUG
    Induction: Daunorubicin 60 mg/m\^2/day (days 1-3). Consolidation: Daunorubicin 45 mg/m\^2/day (days 1-2).
  • Cytarabine — DRUG
    Induction: Cytarabine 100 mg/m\^2/day (days 1-7). Consolidation: Cytarabine 100 mg/m\^2/day (continuous infusion on days 1-5).

Study Details

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.

Key Dates

Start date
Jun 18, 2015
Status verified
Sep 2022
Primary completion
Sep 13, 2016
Completion
Feb 1, 2021

Study Design

Enrollment
21 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Dose Escalation - Selinexor
    Dose escalation of selinexor with fixed doses of daunorubicin and cytarabine. Induction Therapy may be followed by Consolidation Phase and Maintenance Phase as outlined in the Detailed Description and Intervention Descriptions.

Primary Outcome Measure

Maximal Tolerated Dose (MTD) of Selinexor [ Time Frame: Up to 18 months ]

Locations (1)

FacilityCityStateZIPSite coordinators
H. Lee Moffitt Cancer Center and Research InstituteTampaFlorida33612-

Find similar trials in Tampa, FL

By condition
Leukemia (other)
By specialty
OncologyBlood cancer
By research site
H. Lee Moffitt Cancer Center and Research Institute· Tampa, FL

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