Trial ID or NCT#

NCT02841540

Status

RECRUITING

Purpose

This study will include a Phase 1 dose-finding portion (Cohorts A and B) and a four-arm expansion portion. The primary objectives of the study are to determine the maximum tolerated dose (MTD) and recommended Phase 2 dose (RP2D) of H3B-8800 administered orally in participants with Myelodysplastic Syndromes (MDS), Acute Myeloid Leukemia (AML), or Chronic Myelomonocytic Leukemia (CMML) and to assess the safety and tolerability of H3B-8800 as a single agent administered orally once daily on a 5 days on/9 days off repeated dosing schedule in 28-day cycles in participants with MDS, AML, or CMML.

Official Title

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

Eligibility Criteria

Ages Eligible for Study: Older than 18 Years
Sexes Eligible for Study: All
Accepts Healthy Volunteers: No

Investigator(s)

Peter Greenberg
Hematologist, Medical oncologist, Leukemia specialist
Professor of Medicine (Hematology), Emeritus

Contact us to find out if this trial is right for you.

CONTACT

Jack Taw
(650) 723-2781