Acute Myeloid Leukemia Clinical Trial

Open-label Study of FT-2102 With or Without Azacitidine or Cytarabine in Patients With AML or MDS With an IDH1 Mutation

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.

View Eligibility Criteria

Eligibility Criteria

Inclusion Criteria:

Pathologically proven acute myeloid leukemia (AML) (except acute promyelocytic leukemia [APL] with the t(15;17) translocation) or intermediate, high-risk, or very high risk Myelodysplastic Syndrome (MDS) as defined by the World Health Organization (WHO) criteria or Revised International Prognostic Scoring System (IPSS-R) which is relapsed or refractory (R/R) to standard therapy and/or for which standard therapy is contraindicated or which has not adequately responded to standard therapy.
Patients must have documented IDH1-R132 gene-mutated disease as evaluated by the site
Good performance status
Good kidney and liver function

Exclusion Criteria:

Patients with symptomatic central nervous system (CNS) metastases or other tumor location (such as spinal cord compression, other compressive mass, uncontrolled painful lesion, bone fracture, etc.) necessitating an urgent therapeutic intervention, palliative care, surgery or radiation therapy
Congestive heart failure (New York Heart Association Class III or IV) or unstable angina pectoris. Previous history of myocardial infarction within 1 year prior to study entry, uncontrolled hypertension or uncontrolled arrhythmias
Active, uncontrolled bacterial, viral, or fungal infections, requiring systemic therapy

Study is for people with:

Acute Myeloid Leukemia

Phase:

Phase 1

Estimated Enrollment:

336

Study ID:

NCT02719574

Recruitment Status:

Completed

Sponsor:

Forma Therapeutics, Inc.

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There are 46 Locations for this study

See Locations Near You

UCLA Medical Center
Los Angeles California, 90024, United States
UC Davis Comprehensive Cancer Center
Sacramento California, 95817, United States
Yale University
New Haven Connecticut, 06510, United States
University of Miami
Miami Florida, 33136, United States
Emory Winship Cancer Institute
Atlanta Georgia, 30322, United States
Northwestern University Feinberg School of Medicine
Chicago Illinois, 60611, United States
University of Maryland Greenebaum Cancer Center
Baltimore Maryland, 21201, United States
Karmanos Cancer Institute
Detroit Michigan, 48201, United States
Roswell Park Cancer Institute
Buffalo New York, 14263, United States
New York Medical College
Hawthorne New York, 10532, United States
Columbia University Medical Center
New York New York, 10032, United States
Cornell University Weill Medical College
New York New York, 10065, United States
Duke University Medical Center
Durham North Carolina, 27705, United States
The Ohio State University
Columbus Ohio, 43210, United States
Oregon Health & Science University
Portland Oregon, 97229, United States
Sarah Cannon Research Institute - Tennessee Oncology
Nashville Tennessee, 37203, United States
Vanderbilt University Medical Center
Nashville Tennessee, 37232, United States
University of Texas Southwestern Medical Center
Dallas Texas, 75390, United States
MD Anderson Cancer Center
Houston Texas, 77030, United States
Royal Adelaide Hospital
Adelaide South Australia, 5000, Australia
The Alfred Hospital
Melbourne Victoria, 3004, Australia
Victoria Cancer Care Center
Parkville Victoria, 3000, Australia
Sir Charles Gairdner Hospital
Nedlands Western Australia, 6009, Australia
Box Hill Hospital, Monash University and Eastern Health Clinical School
Box Hill , 3128, Australia
Princess Margaret Hospital
Toronto Ontario, M5G 2, Canada
Service d'Hématologie Clinique, Hôpital Avicenne-APHP-Université Paris
Bobigny , 93000, France
Assistance Publique Hopitaux de Marseille (AP-HM) - Hopital Nord
Marseille , 13005, France
Centre Hospitalier Universitaire Nantes
Nantes , 44093, France
Hôpital Saint-Louis
Paris , 75010, France
Hopitaux Universitaires Est Parisien Hopital Saint-Antoine
Paris , 75012, France
Centre Hospitalier Universitaire (CHU) Bordeaux - Hospitaux du Haut Leveque
Pessac , 33604, France
Centre Hospitalier Lyon Sud
Pierre-Bénite , 69495, France
University Hospital of Rennes
Rennes , 35033, France
Institut Universitaire du Cancer Toulouse - Oncopole
Toulouse , 31059, France
Centre Hospitalier Universitaire de Nancy - Hopital Brabois
Vandœuvre-lès-Nancy , 54511, France
Institut de Cancérologie Gustave Roussy
Villejuif , 94805, France
Staedtisches Klinikum Braunschweig gGmbH
Braunschweig , , Germany
Universitaetsklinikum Giessen und Marburg GmbH - Klinik fuer Innere Medizin
Gießen , , Germany
Landeszentrum fuer Zell- und Gentherapie
Halle (Saale) , , 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 , 13620, Korea, Republic of
Seoul National University Hospital
Seoul , 03080, Korea, Republic of
Hospital Vall d'Hebron
Barcelona , 08035, Spain
Hospital Clinic de Barcelona
Barcelona , 8036, Spain
Institut Català d'Oncologia-Hospital Duran i Reynals
Barcelona , 8908, Spain
Hospital Universitario 12 De Octubre
Madrid , 28041, Spain
Hospital Clínico Universitario de Salamanca
Salamanca , 37007, Spain
Hospital La Fe
Valencia , 46026, Spain
University College London Hospitals NHS Foundation Trust
London , NW1 2, 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 , SM2 5, United Kingdom

How clear is this clinincal trial information?

Study is for people with:

Acute Myeloid Leukemia

Phase:

Phase 1

Estimated Enrollment:

336

Study ID:

NCT02719574

Recruitment Status:

Completed

Sponsor:


Forma Therapeutics, Inc.

How clear is this clinincal trial information?

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