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

NCT02530476 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 17

Last updated 2020-03-31

Study results available
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Summary

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.

Conditions

Interventions

DRUG

Selinexor

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.

DRUG

Sorafenib

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.

Sponsors & Collaborators

  • Karyopharm Therapeutics Inc

    collaborator INDUSTRY

  • National Cancer Institute (NCI)

    collaborator NIH

  • M.D. Anderson Cancer Center

    lead OTHER

Principal Investigators

  • Naval Daver, MD · M.D. Anderson Cancer Center

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-12-08
Primary Completion
2019-04-08
Completion
2019-04-08
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

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 NCT02530476 on ClinicalTrials.gov