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Assay of the splicing modulator H3B-8800 in subjects with myelodysplastic syndromes, acute myeloid leukemia and chronic myelomonocytic leukemia
THE MAIN OBJECTIVE OF THIS STUDY IS TO EVALUATE THE SAFETY OF H3B-8800 (ALSO KNOWN AS RVT-2001), THE STUDY MEDICATION, TO FIND OUT WHAT IS THE MOST APPROPRIATE DOSE FOR PATIENTS AND TO BETTER UNDERSTAND HOW IT WORKS IN THEIR TYPE OF CANCER. INFORMATION WILL ALSO BE COLLECTED ON SURVIVAL AND SIDE EFFECTS THAT MAY OCCUR DURING THE STUDY.
Technical Summary
- PHASE 1, OPEN-LABEL, MULTICENTER TRIAL TO EVALUATE THE SAFETY, PHARMACOKINETICS AND PHARMACODYNAMICS OF THE SPLICING MODULATOR H3B-8800 IN SUBJECTS WITH MYELODYSPLASTIC SYNDROMES, ACUTE MYELOID LEUKEMIA AND CHRONIC MYELOMONOCYTIC LEUKEMIA
- Code EudraCT: 2016-001792-70
- Protocol number: H3B-8800-G000-101
- Promoter: H3 Biomedicine Inc.
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