Spots Global Cancer Trial Database for A Study of H3B-8800 (RVT-2001) in Participants With Lower Risk Myelodysplastic Syndromes
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Trial Identification
Brief Title: A Study of H3B-8800 (RVT-2001) in Participants With Lower Risk Myelodysplastic Syndromes
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
Study ID: NCT02841540
Interventions
Study Description
Brief 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
Detailed Description: This study is a Phase 1, open-label, first-in-human (FIH) study designed to evaluate the safety, tolerability, pharmacokinetics (PK), pharmacodynamics (PD), and preliminary antitumor activity of H3B-8800 (RVT-2001) in subset of participants with Myelodysplastic Syndromes (MDS), Acute Myeloid Leukemia (AML), or Chronic Myelomonocytic Leukemia (CMML). The study consists of three parts, the dose escalation part (Part 1) exploring multiple once daily (QD) schedules and MDS Expansion part (Part 2) and Dose Optimization part (Part 3) exploring dosing schedules in lower-risk MDS.
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
Arizona Oncology Associates, Tucson, Arizona, United States
City of Hope, Duarte, California, United States
City of Hope, Irvine, California, United States
Rocky Mountain Cancer Center, Aurora, Colorado, United States
Mayo Clinic Jacksonville, Jacksonville, Florida, United States
University of Miami, Miami, Florida, United States
Massachusetts General Hospital, Boston, Massachusetts, United States
Beth Israel Deaconess Medical Center, Boston, Massachusetts, United States
Dana Farber Cancer Institute, Boston, Massachusetts, United States
Karmanos Cancer Institute, Detroit, Michigan, United States
Mayo Clinic, Rochester, Minnesota, United States
Oncology Associates of Oregon, Eugene, Oregon, United States
Texas Oncology, Austin, Texas, United States
MD Anderson Cancer Center, Houston, Texas, United States
Virginia Cancer Specialist, Fairfax, Virginia, United States
Algemeen Ziekenhuis Klina, Brasschaat, , Belgium
AZ Sint-Jan Brugge Oostende AV, Brugge, , Belgium
Universiteit Gent, Gent, , Belgium
University Hospitals Leuven, Leuven, , Belgium
Institut Gustave Roussy, Villejuif, Val-de-Marne, France
CHU Amiens-Picardie, Amiens, , France
Centre Hospitalier Universitaire d'Angers (CHU d'Angers), Angers, , France
Centre Hospitalier Universitaire (CHU) de Bordeaux, Bordeaux, , France
Centre Hospitalier - Le Mans, Le Mans, , France
Hôpital Claude Huriez, Lille, , France
Centre Hospitalier Lyon Sud, Pierre-Bénite, , France
Azienda Ospedaliera Universitaria di Bologna - Policlinico S. Orsola Malpighi, Bologna, , Italy
Fondazione IRCCS Cà Granda Ospedale Policlinico Maggiore, Milano, , Italy
Fondazione IRCCS Policlinico San Matteo, Pavia, , Italy
IRCCS Istituto Clinico Humanitas Cancer Center, Rozzano, , Italy
National Cancer Center, Gyeonggi-do, Goyang-si, Korea, Republic of
Daegu Catholic University Medical Center, Daegu, , Korea, Republic of
Gachon University Gil Medical Center, Incheon, , Korea, Republic of
Asan Medical Center, Seoul, , Korea, Republic of
Hanyang University Seoul Hospital, Seoul, , Korea, Republic of
Samsung Medical Center, Seoul, , Korea, Republic of
Seoul National University Hospital, Seoul, , Korea, Republic of
The Catholic University of Korea Seoul St. Mary's Hospital, Seoul, , Korea, Republic of
Clinica Universidad de Navarra, Pamplona, Navarra, Spain
Hospital Universitario Valle de Hebrón, Barcelona, , Spain
Hospital General Universitario Gregorio Marañon, Madrid, , Spain
Hospital Universitario Fundación Jiménez Díaz, Madrid, , Spain
Complejo Asistencial Universitario de Salamanca, Salamanca, , Spain
Hospital Universitario y Politécnico La Fe de Valencia, Valencia, , Spain
Changhua Christian Hospital, Changhua, , Taiwan
Chang-Gung Memorial Hospital, Chiayi, Chiayi City, , Taiwan
China Medical University Hospital, Taichung, , Taiwan
National Cheng Kung University Hospital, Tainan, , Taiwan
National Taiwan University Hospital, Taipei, , Taiwan
Contact Details
Name: Keisuke Kuida, MD, PhD
Affiliation: Hemavant Sciences
Role: STUDY_DIRECTOR
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