Phase I/II, Study of Selective Inhibitor of Nuclear Export (SINE) Selinexor (KPT-330) + Sorafenib in Acute Myeloid Leukemia

Part of paid clinical trials in Houston, Texas.

Sponsor
M.D. Anderson Cancer Center
Study ID
NCT02530476
Phase
PHASE1/PHASE2
Status
Completed

Conditions

Eligibility Criteria

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

Interventions

  • Selinexor — DRUG
    Phase I Starting Dose of Selinexor: 80 mg by mouth twice weekly for a 28 day cycle. Phase II Starting Dose of Selinexor: Maximum tolerated dose from Phase I.
  • Sorafenib — DRUG
    Phase I Starting Dose of Sorafenib: 400 mg by mouth twice daily for a 28 day cycle. Phase II Starting Dose of Sorafenib: Maximum tolerated dose combination from Phase I.

Study Details

There are 2 parts to this study: Part 1 (dose escalation) and Part 2 (dose expansion). The goal of Part 1 of this clinical research study is to find the highest tolerated dose of the combination of selinexor (KPT-330) and sorafenib (Nexavar) that can be given to patients with FLT3-ITD and -D835 mutated acute myeloid leukemia (AML) or FLT3-mutated high-risk myelodysplastic syndrome (MDS). The goal of Part 2 of this study is to learn if the dose found in Part 1 can help to control the disease. The safety of the drug combination will also be studied in both parts of this study. This is an investigational study. Sorafenib is FDA approved and commercially available to treat hepatocellular cancer. Selinexor is not FDA approved or commercially available. It is currently being used for research purposes only. The combination of selinexor and sorafenib to treat FLT3-mutated AML and high-risk MDS is investigational. The study doctor can explain how the study drugs are designed to work. Up to 52 participants will take part in this study. All will be enrolled at MD Anderson.

Key Dates

Start date
Dec 8, 2015
Status verified
Mar 2020
Primary completion
Apr 8, 2019
Completion
Apr 8, 2019

Study Design

Enrollment
17 participants (actual)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Phase I Group 1 Selinexor + Sorafenib
    Cohort includes those with FLT3-ITD and -D835 mutated participants with relapsed/refractory AML, including participants who may have been previously exposed to one or more FLT3-inhibitors. Phase I Starting Dose of Sorafenib: 400 mg by mouth twice daily for a 28 day cycle. Phase I Starting Dose of Selinexor: 80 mg by mouth twice weekly for a 28 day cycle.
  • Experimental: Cohort 1 (FLT3-ITD inhibitor failure cohort)
    Cohort includes those with FLT3-ITD and -D835 mutated relapsed/refractory AML who have failed therapy with up to two prior salvage regimens. Phase II Starting Dose of Sorafenib: Maximum tolerated dose combination from Phase I. Phase II Starting Dose of Selinexor: Maximum tolerated dose from Phase I.
  • Experimental: Cohort 2 (FLT3-ITD inhibitor naive cohort)
    Cohort includes those with FLT3-ITD and -D835 mutated relapsed/refractory AML who have failed therapy with up to two prior salvage regimens. Phase II Starting Dose of Sorafenib: Maximum tolerated dose combination from Phase I. Phase II Starting Dose of Selinexor: Maximum tolerated dose from Phase I.
  • Experimental: Phase I Group 2 Selinexor + Sorafenib
    Cohort includes those with FLT3-ITD and -D835 mutated participants with relapsed/refractory AML, including participants who may have been previously exposed to one or more FLT3-inhibitors. Phase I Starting Dose of Sorafenib: 400 mg by mouth twice daily for a 28 day cycle. Phase I Starting Dose of Selinexor: 80 mg by mouth twice weekly for a 28 day cycle. Phase I Group 2 received Selinexor 80 mg by mouth twice weekly for a 28 day cycle.

Primary Outcome Measure

Maximum Tolerated Dose (MTD) of Selinexor With Sorafenib [ Time Frame: 28 days ]

Locations (1)

FacilityCityStateZIPSite coordinators
University of Texas MD Anderson Cancer CenterHoustonTexas77030-

Find similar trials in Houston, TX

By condition
Leukemia (other)
By specialty
OncologyBlood cancer
By research site
University of Texas MD Anderson Cancer Center· Houston, TX

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