Phase I/II, Study of Selective Inhibitor of Nuclear Export (SINE) Selinexor (KPT-330) + Sorafenib in Acute Myeloid Leukemia
Status:
Completed
Trial end date:
2019-04-08
Target enrollment:
Participant gender:
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.
Phase:
Phase 1/Phase 2
Details
Lead Sponsor:
M.D. Anderson Cancer Center
Collaborators:
Karyopharm Therapeutics Inc Karyopharm Therapeutics, Inc National Cancer Institute (NCI)