An Open-label, Multicenter Phase 1 Trial to Evaluate the Safety, Pharmacokinetics and Pharmacodynamics of Splicing Modulator H3B-8800 for Subjects With Myelodysplastic Syndromes, Acute Myeloid Leukemia, and Chronic Myelomonocytic Leukemia
The main goal of this study is to learn about the safety of H3B-8800, to find the best dose that can be given to humans, and to understand how it works in myelodysplastic syndrome (MDS), acute myeloid leukemia (AML), or chronic myelomonocytic leukemia (CMML). 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 tolerable dose of H3B-8800 that can be given to patients with MDS, AML, or CMML. The goal of Part 2 of this study is to learn if the dose of H3B-8800 found in Part 1 can help to control the disease in patients with certain types of genetic mutations (changes). The safety of H3B-8800 will also be studied in both parts. This is the first study using H3B-8800 in humans. However, other patients have received the drug on this study already.
Treatment Location: N/A
IRB Review and Approval Date: 03/24/2017
Recruitment Status: Closed
Projected Accrual: N/A
Information and next steps
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