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

PHASE1/PHASE2CompletedINTERVENTIONAL
Enrollment

336

Participants

Timeline

Start Date

April 30, 2016

Primary Completion Date

December 28, 2023

Study Completion Date

January 24, 2024

Conditions
Acute Myeloid LeukemiaAcute Myelogenous LeukemiaMyelodysplastic Syndrome
Interventions
DRUG

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

DRUG

Azacitidine

azacitidine will be administered per site's standard of care

DRUG

Cytarabine

low-dose cytarabine will be administered per site's standard of care

Trial Locations (60)

3000

Victoria Cancer Care Center, Parkville

3004

The Alfred Hospital, Melbourne

3128

Box Hill Hospital, Monash University and Eastern Health Clinical School, Box Hill

5000

Royal Adelaide Hospital, Adelaide

6009

Sir Charles Gairdner Hospital, Nedlands

8036

Hospital Clinic de Barcelona, Barcelona

8908

Institut Català d'Oncologia-Hospital Duran i Reynals, Barcelona

10032

Columbia University Medical Center, New York

10065

Cornell University Weill Medical College, New York

10532

New York Medical College, Hawthorne

13005

Assistance Publique Hopitaux de Marseille (AP-HM) - Hopital Nord, Marseille

13620

Seoul National University Bundang Hospital, Gumi

14263

Roswell Park Cancer Institute, Buffalo

21201

University of Maryland Greenebaum Cancer Center, Baltimore

27705

Duke University Medical Center, Durham

28041

Hospital Universitario 12 De Octubre, Madrid

30322

Emory Winship Cancer Institute, Atlanta

31059

Institut Universitaire du Cancer Toulouse - Oncopole, Toulouse

33136

University of Miami, Miami

33604

Centre Hospitalier Universitaire (CHU) Bordeaux - Hospitaux du Haut Leveque, Pessac

35033

University Hospital of Rennes, Rennes

37007

Hospital Clínico Universitario de Salamanca, Salamanca

37203

Sarah Cannon Research Institute - Tennessee Oncology, Nashville

37232

Vanderbilt University Medical Center, Nashville

43210

The Ohio State University, Columbus

44093

Centre Hospitalier Universitaire Nantes, Nantes

46026

Hospital La Fe, Valencia

48201

Karmanos Cancer Institute, Detroit

54511

Centre Hospitalier Universitaire de Nancy - Hopital Brabois, Vandœuvre-lès-Nancy

60611

Northwestern University Feinberg School of Medicine, Chicago

69495

Centre Hospitalier Lyon Sud, Pierre-Bénite

75010

Hôpital Saint-Louis, Paris

75012

Hopitaux Universitaires Est Parisien Hopital Saint-Antoine, Paris

75390

University of Texas Southwestern Medical Center, Dallas

77030

MD Anderson Cancer Center, Houston

90024

UCLA Medical Center, Los Angeles

93000

Service d'Hématologie Clinique, Hôpital Avicenne-APHP-Université Paris, Bobigny

94805

Institut de Cancérologie Gustave Roussy, Villejuif

95817

UC Davis Comprehensive Cancer Center, Sacramento

97229

Oregon Health & Science University, Portland

06510

Yale University, New Haven

M5G 2M9

Princess Margaret Hospital, Toronto

Unknown

Staedtisches Klinikum Braunschweig gGmbH, Braunschweig

Universitaetsklinikum Giessen und Marburg GmbH - Klinik fuer Innere Medizin, Giessen

Landeszentrum fuer Zell- und Gentherapie, Halle

Universitätsklinikum Münster Medizinische Klinik A, Hämatologie, Hämostaseologi, Münster

AOU S. Luigi Gonzaga - Orbassano, Orbassano

Ospedale Mazzoni - UOC Ematologia Ascoli Piceno, Ascoli Piceno

Universita di Bologna, Bologna

Dipartimento di Oncologia Medica - IRST IRCC, Meldola

Università degli Studi di Parma, Parma

U.O. Ematologia Ravenna, Ravenna

Hospital Rimini Hematology, Department of Oncology and Hematoloy, Rimini

St. George's University Hospital, London

Churchill Hospital, Oxford

Southampton General Hospital, Southampton

03080

Seoul National University Hospital, Seoul

08035

Hospital Vall d'Hebron, Barcelona

NW1 2PG

University College London Hospitals NHS Foundation Trust, London

SM2 5PT

Royal Marsden Hospital, Sutton

Sponsors
All Listed Sponsors
lead

Forma Therapeutics, Inc.

INDUSTRY