Phase I/II, Study of Selective Inhibitor of Nuclear Export (SINE) Selinexor (KPT-330) + Sorafenib in Acute Myeloid Leukemia | Aplastic Anemia and MDS International Foundation

Clinical Trial: NCT02530476

Phase I/II, Study of Selective Inhibitor of Nuclear Export (SINE) Selinexor (KPT-330) + Sorafenib in Acute Myeloid Leukemia
For more details on this clinical trial, including contact information, please see this trial’s listing on clinicaltrials.gov:
Purpose: 

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 mutated AML or FLT3-mutated high-risk 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.

Status: 
Recruiting
Study Date: 
Tue, 12/01/2015 to Sun, 12/01/2019
Bone Marrow Disease(s): 
myelodysplastic syndromes (MDS)
Intervention: 
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. Other Name: KPT-330 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. Other Names: Nexavar BAY 43-9006