ONC201 in Relapsed/Refractory Acute Leukemias and High-risk Myelodysplastic Syndromes (HR-MDS) | Aplastic Anemia and MDS International Foundation

Clinical Trial: NCT02392572

ONC201 in Relapsed/Refractory Acute Leukemias and High-risk Myelodysplastic Syndromes (HR-MDS)
For more details on this clinical trial, including contact information, please see this trial’s listing on clinicaltrials.gov:
Purpose: 

The goal of Phase I of this clinical research study is to find the highest tolerable dose of ONC201 that can be given to patients with relapsed or refractory AML, ALL, or MDS.

The goal of Phase II of this study is to learn if the dose of ONC201 found in Phase I can help to control the disease. The safety of the study drug will be studied in both phases of this study. This is the first study using ONC201 in humans. ONC201 is in a very early stage of development for use in humans. Providing direct medical benefit to you is not the purpose of this study. While Phase II will look at the effectiveness of the study drug, the main purpose of this study is to learn about the safety of the drug.

Status: 
Recruiting
Study Date: 
Sun, 11/01/2015 to Tue, 11/01/2022
Bone Marrow Disease(s): 
myelodysplastic syndromes (MDS)
Intervention: 
Drug: ONC201 Phase I Starting dose of ONC201: 125 mg by mouth once every 3 weeks. Phase II Starting dose of ONC201: MTD from Phase I.