A Study of H3B-8800 (RVT-2001) in Participants With Lower Risk Myelodysplastic Syndromes
NCT02841540 · Status: TERMINATED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 127
Last updated 2024-02-14
Summary
A Phase 1, an Open-label, Multicenter Phase 1 Trial to Evaluate the Safety, Pharmacokinetics and Pharmacodynamics of Splicing Modulator H3B-8800 (RVT-2001) for Subjects With Myelodysplastic Syndromes, Acute Myeloid Leukemia, and Chronic Myelomonocytic Leukemia
Conditions
- Leukemia, Myeloid, Acute
- Myelodysplastic Syndromes
- Leukemia, Myelomonocytic, Chronic
Interventions
- DRUG
-
H3B-8800 (RVT-2001)
H3B-8800 (RVT-2001) orally at specified doses and schedules.
Sponsors & Collaborators
-
Hemavant Sciences GmbH
lead INDUSTRY
Principal Investigators
-
Keisuke Kuida, MD, PhD · Hemavant Sciences
Study Design
- Allocation
- NON_RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2016-10-06
- Primary Completion
- 2024-02-13
- Completion
- 2024-02-13
- FDA Drug
- Yes
Countries
- United States
- Belgium
- France
- Italy
- South Korea
- Spain
- Taiwan
Study Locations
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