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Open-label Study of FT-2102 With or Without Azacitidine or Cytarabine in Patients With AML or MDS With an IDH1 Mutation
Sponsor: Forma Therapeutics, Inc.
Summary
This Phase 1/2 study will evaluate the safety, efficacy, PK, and PD of FT-2102 (olutasidenib) as a single agent or in combination with azacitidine or cytarabine. The Phase 1 stage of the study is split into 2 distinct parts: a dose escalation part, which will utilize an open-label design of FT-2102 (olutasidenib) (single agent) and FT-2102 (olutasidenib) + azacitidine (combination agent) administered via one or more intermittent dosing schedules followed by a dose expansion part. The dose expansion part will enroll patients in up to 5 expansion cohorts, exploring single-agent FT-2102 (olutasidenib) activity as well as combination activity with azacitidine or cytarabine. Following the completion of the relevant Phase 1 cohorts, Phase 2 will begin enrollment. Patients will be enrolled across 8 different cohorts, examining the effect of FT-2102 (olutasidenib) (as a single agent) and FT-2102 (olutasidenib) + azacitidine (combination) on various AML/MDS disease states.
Official title: A Phase 1/2, Multicenter, Open-label Study of FT-2102 as a Single Agent and in Combination With Azacitidine or Cytarabine in Patients With Acute Myeloid Leukemia or Myelodysplastic Syndrome With an IDH1 Mutation
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
336
Start Date
2016-04-30
Completion Date
2024-01-24
Last Updated
2026-06-29
Healthy Volunteers
No
Interventions
FT-2102 (olutasidenib)
FT-2102 (olutasidenib) will be supplied as 50 mg or 150 mg capsules and will be administered per the protocol defined frequency and dose level
Azacitidine
azacitidine will be administered per site's standard of care
Cytarabine
low-dose cytarabine will be administered per site's standard of care
Locations (60)
UCLA Medical Center
Los Angeles, California, United States
UC Davis Comprehensive Cancer Center
Sacramento, California, United States
Yale University
New Haven, Connecticut, United States
University of Miami
Miami, Florida, United States
Emory Winship Cancer Institute
Atlanta, Georgia, United States
Northwestern University Feinberg School of Medicine
Chicago, Illinois, United States
University of Maryland Greenebaum Cancer Center
Baltimore, Maryland, United States
Karmanos Cancer Institute
Detroit, Michigan, United States
Roswell Park Cancer Institute
Buffalo, New York, United States
New York Medical College
Hawthorne, New York, United States
Columbia University Medical Center
New York, New York, United States
Cornell University Weill Medical College
New York, New York, United States
Duke University Medical Center
Durham, North Carolina, United States
The Ohio State University
Columbus, Ohio, United States
Oregon Health & Science University
Portland, Oregon, United States
Sarah Cannon Research Institute - Tennessee Oncology
Nashville, Tennessee, United States
Vanderbilt University Medical Center
Nashville, Tennessee, United States
University of Texas Southwestern Medical Center
Dallas, Texas, United States
MD Anderson Cancer Center
Houston, Texas, United States
Royal Adelaide Hospital
Adelaide, South Australia, Australia
The Alfred Hospital
Melbourne, Victoria, Australia
Victoria Cancer Care Center
Parkville, Victoria, Australia
Sir Charles Gairdner Hospital
Nedlands, Western Australia, Australia
Box Hill Hospital, Monash University and Eastern Health Clinical School
Box Hill, Australia
Princess Margaret Hospital
Toronto, Ontario, Canada
Service d'Hématologie Clinique, Hôpital Avicenne-APHP-Université Paris
Bobigny, France
Assistance Publique Hopitaux de Marseille (AP-HM) - Hopital Nord
Marseille, France
Centre Hospitalier Universitaire Nantes
Nantes, France
Hôpital Saint-Louis
Paris, France
Hopitaux Universitaires Est Parisien Hopital Saint-Antoine
Paris, France
Centre Hospitalier Universitaire (CHU) Bordeaux - Hospitaux du Haut Leveque
Pessac, France
Centre Hospitalier Lyon Sud
Pierre-Bénite, France
University Hospital of Rennes
Rennes, France
Institut Universitaire du Cancer Toulouse - Oncopole
Toulouse, France
Centre Hospitalier Universitaire de Nancy - Hopital Brabois
Vandœuvre-lès-Nancy, France
Institut de Cancérologie Gustave Roussy
Villejuif, France
Staedtisches Klinikum Braunschweig gGmbH
Braunschweig, Germany
Universitaetsklinikum Giessen und Marburg GmbH - Klinik fuer Innere Medizin
Giessen, Germany
Landeszentrum fuer Zell- und Gentherapie
Halle, Germany
Universitätsklinikum Münster Medizinische Klinik A, Hämatologie, Hämostaseologi
Münster, Germany
AOU S. Luigi Gonzaga - Orbassano
Orbassano, Turin, Italy
Ospedale Mazzoni - UOC Ematologia Ascoli Piceno
Ascoli Piceno, Italy
Universita di Bologna
Bologna, Italy
Dipartimento di Oncologia Medica - IRST IRCC
Meldola, Italy
Università degli Studi di Parma
Parma, Italy
U.O. Ematologia Ravenna
Ravenna, Italy
Hospital Rimini Hematology, Department of Oncology and Hematoloy
Rimini, Italy
Seoul National University Bundang Hospital
Gumi, South Korea
Seoul National University Hospital
Seoul, South Korea
Hospital Vall d'Hebron
Barcelona, Spain
Hospital Clinic de Barcelona
Barcelona, Spain
Institut Català d'Oncologia-Hospital Duran i Reynals
Barcelona, Spain
Hospital Universitario 12 De Octubre
Madrid, Spain
Hospital Clínico Universitario de Salamanca
Salamanca, Spain
Hospital La Fe
Valencia, Spain
University College London Hospitals NHS Foundation Trust
London, United Kingdom
St. George's University Hospital
London, United Kingdom
Churchill Hospital
Oxford, United Kingdom
Southampton General Hospital
Southampton, United Kingdom
Royal Marsden Hospital
Sutton, United Kingdom