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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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02719574
Recruitment Status : Recruiting
First Posted : March 25, 2016
Last Update Posted : December 5, 2019
Sponsor:
Information provided by (Responsible Party):
Forma Therapeutics, Inc.

Brief 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.

Condition or disease Intervention/treatment Phase
Acute Myeloid Leukemia Acute Myelogenous Leukemia Myelodysplastic Syndrome Drug: FT-2102 (olutasidenib) Drug: Azacitidine Drug: Cytarabine Phase 1 Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 500 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Study Start Date : April 2016
Estimated Primary Completion Date : April 2020
Estimated Study Completion Date : September 2020


Arm Intervention/treatment
Experimental: PH1 Dose Escalation & Expansion FT-2102 (olutasidenib) 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

Experimental: PH1 Esc. and Exp. FT-2102 (olutasidenib)+Azacitidine 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
Other Name: Vidaza

Experimental: PH1 Esc. and Exp. FT-2102 (olutasidenib)+Cytarabine 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: Cytarabine
low-dose cytarabine will be administered per site's standard of care

Experimental: PH2 Cohort 1 FT-2102 (olutasidenib) Single Agent
Relapsed or Refractory (R/R) AML
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

Experimental: PH2 Cohort 2 FT-2102 (olutasidenib) Single Agent
AML in morphologic complete remission or complete remission with incomplete blood count recovery (CR/CRi) after prior therapy with residual IDH1-R132 mutation
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

Experimental: PH2 Cohort 3 FT-2102 (olutasidenib) Single Agent
R/R AML/MDS, previously treated with an IDH1 inhibitor
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

Experimental: PH2 Cohort 4 FT-2102 (olutasidenib)+Azacitidine
R/R AML/MDS that are naïve to prior hypomethylating therapy and IDH1 inhibitor therapy
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
Other Name: Vidaza

Experimental: PH2 Cohort 5 FT-2102 (olutasidenib)+Azacitidine
R/R AML/MDS that have inadequately responded to or have progressed on prior hypomethylating therapy
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
Other Name: Vidaza

Experimental: PH2 Cohort 6 FT-2102 (olutasidenib)+Azacitidine
R/R AML/MDS that have been previously treated with single-agent IDH1 inhibitor therapy as their last therapy prior to study enrollment
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
Other Name: Vidaza

Experimental: PH2 Cohort 7 FT-2102 (olutasidenib) Single Agent
Treatment naïve AML for whom standard treatments are contraindicated
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

Experimental: PH2 Cohort 8 FT-2102 (olutasidenib)+Azacitidine
Treatment naïve AML who are candidates for azacitidine first line treatment
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
Other Name: Vidaza




Primary Outcome Measures :
  1. Maximum Tolerated Doses (MTDs) or Maximum Evaluated Doses (MEDs) [Phase 1] [ Time Frame: Within first 4 weeks of treatment ]
  2. Number of Participants with a Dose Limiting Toxicity (DLT) [Phase 1] [ Time Frame: Within first 4 weeks of treatment ]
  3. Doses recommended for future studies [Phase 1] [ Time Frame: Within first 4 weeks of treatment ]
  4. Complete Response (CR and CRh) Rate of FT-2102 (olutasidenib) single-agent or in combination with Azacitidine in patients with AML/MDS [Phase 2 Cohorts 1, 3-8] [ Time Frame: As per modified IWG Response Assessment Guidelines for AML and MDS based on investigator's assessment on day 1 of each cycle through study completion ]
  5. 4-Month Relapse Free Survival (RFS) of FT-2102 (olutasidenib) single-agent [Phase 2 Cohort 2] [ Time Frame: From time of entry on study through progression, up to 30 weeks, on average ]

Secondary Outcome Measures :
  1. Area under the plasma concentration versus time curve (AUC) [Phase 1 and Phase 2] [ Time Frame: Blood samples for PK analysis collected at multiple visits during the first 60 days of treatment and on day 1 of all cycles following the first 30 days ]
  2. Peak Plasma Concentration (Cmax) [Phase 1 and Phase 2] [ Time Frame: Blood samples for PK analysis collected at multiple visits during the first 60 days of treatment and on day 1 of all cycles following the first 30 days ]
  3. Time of peak plasma concentration Tmax [Phase 1 and Phase 2] [ Time Frame: Blood samples for PK analysis collected at multiple visits during the first 60 days of treatment and on day 1 of all cycles following the first 30 days ]
  4. Time for half of the drug to be absent in blood stream following dose (T 1/2) [Phase 1 and Phase 2] [ Time Frame: Blood samples for PK analysis collected at multiple visits during the first 60 days of treatment and on day 1 of all cycles following the first 30 days ]
  5. Rate at which drug is removed from blood stream (CL/F) [Phase 1 and Phase 2] [ Time Frame: Blood samples for PK analysis collected at multiple visits during the first 60 days of treatment and on day 1 of all cycles following the first 30 days ]
  6. Rate of drug distribution within the blood stream (Vd/F) [Phase 1 and Phase 2] [ Time Frame: Blood samples for PK analysis collected at multiple visits during the first 60 days of treatment and on day 1 of all cycles following the first 30 days ]
  7. Evidence of antileukemic or antimyelodysplastic activity of FT-2102 (olutasidenib) as determined by CR, CRh, CRi, MLFS, Marrow CR, PR, and SD as a single-agent or in combination with azacitidine or cytarabine [Phase 1] [ Time Frame: As per modified IWG Response Assessment Guidelines for AML and MDS based on investigator's assessment on day 1 of each cycle through study completion ]
  8. Incidence and severity of adverse events, clinical laboratory abnormalities, and changes in ECG parameters as assessed by CTCAE v4.0 as a single-agent or in combination with azacitidine [Phase 2] [ Time Frame: Safety will be assessed from time of first dose through 28 days post last dose. ]
  9. Additional measures of antileukemic or antimyelodysplastic activity as determined by CRi, MLFS, Marrow CR, PR, Overall Response (OR), and Stable Disease (SD) of FT-2102 (olutasidenib) alone or in combination with azacitidine [Phase 2] [ Time Frame: As per modified IWG Response Assessment Guidelines for AML and MDS based on investigator's assessment on day 1 of each cycle through study completion ]
  10. Time to Response (TTR) [Phase 2] [ Time Frame: From first dose of study drug through time of first response by blood recovery count, up to 30 weeks, on average ]
  11. Duration of Response (DOR) [Phase 2] [ Time Frame: From time of first response by blood recovery count through relapse, up to 30 weeks, on average ]
  12. Event-Free Survival (EFS) [Phase 2] [ Time Frame: From time of entry on study through progression, up to 30 weeks, on average ]
  13. Overall Survival (OS) [Phase 2] [ Time Frame: From time of entry on study through death or date last known alive at end of follow-up, up to 30 weeks, on average ]
  14. Relapse Free Survival (RFS) [Phase 2] [ Time Frame: From time of entry on study through progression, up to 30 weeks, on average ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
  • Pulmonary disease (e.g. COPD, asthma, etc) that is not controlled (moderate to severe symptoms) with current medication
  • Active, uncontrolled bacterial, viral, or fungal infections, requiring systemic therapy

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02719574


Locations
Hide Hide 85 study locations
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United States, California
UC San Diego Withdrawn
La Jolla, California, United States, 92093
UCLA Medical Center Recruiting
Los Angeles, California, United States, 90024
Contact: Bruck Habtemariam    310-794-0242    bhabtemariam@mednet.ucla.edu   
UC Davis Comprehensive Cancer Center Recruiting
Sacramento, California, United States, 95817
Contact: Linh Dang-Chu    916-734-5930    ldangchu@ucdavis.edu   
United States, Connecticut
Yale University Recruiting
New Haven, Connecticut, United States, 06510
Contact: Tanya Malak    203-785-4699    Tanya.Malak@yale.edu   
United States, Florida
University of Miami Recruiting
Miami, Florida, United States, 33136
Contact: Kristen Englund    305-243-6899      
Florida Cancer Specialists Withdrawn
Sarasota, Florida, United States, 34232
United States, Georgia
Emory Winship Cancer Institute Recruiting
Atlanta, Georgia, United States, 30322
Contact: Shannon Gleason    404-778-4334    shannon.gleason@emory.edu   
United States, Illinois
Northwestern University Feinberg School of Medicine Recruiting
Chicago, Illinois, United States, 60611
Contact: Shirra Dinner, MD    312-472-1234    Shira.Dinner@nm.org   
United States, Indiana
Indiana Blood and Marrow Transplantation Research, LLC Recruiting
Indianapolis, Indiana, United States, 46237
Contact: Melanie Coleman       melanie.Coleman@franciscanalliance.org   
United States, Maryland
University of Maryland Greenebaum Cancer Center Recruiting
Baltimore, Maryland, United States, 21201
Contact: Hongxia Li    410-328-8370    hongxiali@umm.edu   
United States, Michigan
Karmanos Cancer Institute Recruiting
Detroit, Michigan, United States, 48201
Contact: Tony Garn    313-576-9685    garnt@karmanos.org   
United States, New York
Roswell Park Cancer Institute Recruiting
Buffalo, New York, United States, 14263
Contact: Clinical Trials Office    800-767-9355    askroswell@roswellpark.org   
New York Cancer Associates Withdrawn
East Setauket, New York, United States, 11733
New York Medical College Recruiting
Hawthorne, New York, United States, 10532
Contact: Paul Baskind       Paul_Baskind@nymc.edu   
Columbia University Medical Center Recruiting
New York, New York, United States, 10032
Contact: Sarah Leach    212-304-5585    sl3971@cumc.columbia.edu   
Cornell University Weill Medical College Recruiting
New York, New York, United States, 10065
Contact: Elena Lascu    212-746-0974    ell2028@med.cornell.edu   
Stony Brook University Hospital Withdrawn
Stony Brook, New York, United States, 11794
United States, North Carolina
Duke University Medical Center Recruiting
Durham, North Carolina, United States, 27705
Contact: Heme/Onc. Clinical Trials Office    919-681-4769      
United States, Ohio
The Ohio State University Recruiting
Columbus, Ohio, United States, 43210
Contact: Lisa Brenner       Lisa.Brenner@osumc.edu   
United States, Oregon
Oregon Health & Science University Recruiting
Portland, Oregon, United States, 97229
Contact: Chase Brockett    503-346-0227    brocketc@ohsu.edu   
United States, Tennessee
Sarah Cannon Research Institute - Tennessee Oncology Recruiting
Nashville, Tennessee, United States, 37203
Contact: Sarah Walls       sarah.walls@sarahcannon.com   
Vanderbilt University Medical Center Recruiting
Nashville, Tennessee, United States, 37232
Contact: Rebekah Taylor    615-936-1936    Rebekah.J.Taylor@vanderbilt.edu   
United States, Texas
University of Texas Southwestern Medical Center Recruiting
Dallas, Texas, United States, 75390
Contact: Prapti Patel, MD    214-648-3111      
Houston Methodist Research Institute Recruiting
Houston, Texas, United States, 77030
Contact: Ashley Towne    346-238-2006    atowne@houstonmethodist.org   
MD Anderson Cancer Center Recruiting
Houston, Texas, United States, 77030
Contact: Jorge Cortes, MD    713-794-5783    jcortes@mdanderson.org   
United States, Washington
Swedish Cancer Center Withdrawn
Seattle, Washington, United States, 98104
Australia, Australian Capital Territory
Canberra Hospital & Health Service Not yet recruiting
Canberra, Australian Capital Territory, Australia
Australia, New South Wales
St Vincent's Hospital Sydney Recruiting
Darlinghurst, New South Wales, Australia, 2010
Contact: Nada Hamad, MD    +61 02 8382 1111      
Australia, South Australia
Royal Adelaide Hospital Recruiting
Adelaide, South Australia, Australia, 5000
Contact: Devendra Hiwase, MD    +61 (08) 7074 0000      
Australia, Victoria
The Alfred Hospital Recruiting
Melbourne, Victoria, Australia, 3004
Contact: Andrew Wei, MD       andrew.wei@monash.edu   
Victoria Cancer Care Center Recruiting
Parkville, Victoria, Australia, 3000
Contact: Ashish Bajel, MD    +61 (03) 8559 5000      
Australia, Western Australia
Sir Charles Gairdner Hospital Recruiting
Nedlands, Western Australia, Australia, 6009
Contact: Carolyn Grove, MD    +61 (08) 6457 3333      
Australia
Box Hill Hospital, Monash University and Eastern Health Clinical School Recruiting
Box Hill, Australia, 3128
Contact: Anthony Schwarer, MD    + 61 3 8804 9999      
Canada, Ontario
Princess Margaret Hospital Recruiting
Toronto, Ontario, Canada, M5G 2M9
Contact: Deborah Sanfelice    416-946-4501 ext 2867      
France
Service d'Hématologie Clinique, Hôpital Avicenne-APHP-Université Paris Recruiting
Bobigny, France, 93000
Contact: Douay Angelique    +33(0)-1 48 95 75 05      
Assistance Publique Hopitaux de Marseille (AP-HM) - Hopital Nord Recruiting
Marseille, France, 13005
Contact: Regis Costello       recherche.costello@yahoo.com   
Centre Hospitalier Universitaire Nantes Recruiting
Nantes, France, 44093
Contact: Pierre Peterlin       pierre.peterlin@chu-nantes.fr   
Hôpital Saint-Louis Recruiting
Paris, France, 75010
Contact: Pierre Fenaux, MD    +33(0)-1 42 49 49 49      
Hopitaux Universitaires Est Parisien Hopital Saint-Antoine Recruiting
Paris, France, 75012
Contact: Ollivier Legrand, MD    +33(0)-1 49 28 20 00      
Centre Hospitalier Universitaire (CHU) Bordeaux - Hospitaux du Haut Leveque Recruiting
Pessac, France, 33604
Contact: Mathieu Sauvezie    +33(0)-5 57 62 31 09      
Centre Hospitalier Lyon Sud Recruiting
Pierre-Bénite, France, 69495
Contact: Xavier Thomas, MD    +33(0)- 8 25 08 25 69      
University Hospital of Rennes Recruiting
Rennes, France, 35033
Contact: Stanislas Nimubona, MD    +33(0)- 2 99 28 43 21      
Institut Universitaire du Cancer Toulouse - Oncopole Recruiting
Toulouse, France, 31059
Contact: Christian Recher, MD    +33(0)- 5 31 15 63 32      
Centre Hospitalier Universitaire de Nancy - Hopital Brabois Recruiting
Vandœuvre-lès-Nancy, France, 54511
Contact: Caroline Bonmati       c.bonmati@chru-nancy.fr   
Institut de Cancérologie Gustave Roussy Recruiting
Villejuif, France, 94805
Contact: Houssaini Soufyan    +33(0)-1 42 11 48 33      
Germany
Charite Universitaetsmedizin Berlin Recruiting
Berlin, Germany
Contact: Kathrin Rieger       kathrin.rieger@charite.de   
Staedtisches Klinikum Braunschweig gGmbH Recruiting
Braunschweig, Germany
Contact: Oliver Streitbürger    +495315953700    o.streitbuerger@klinikum-braunschweig.de   
Klinikum Chemnitz gGmbH - Klinik fuer Innere Medizin III Recruiting
Chemnitz, Germany
Contact: Katja Schaarschmidt    +49 371 333 43072    k.schaarschmidt@skc.de   
Universitaetsklinikum Giessen und Marburg GmbH - Klinik fuer Innere Medizin Recruiting
Gießen, Germany
Contact: Andreas Neubauer       sekretariat.onkologie@med.uni-marburg.de   
Landeszentrum fuer Zell- und Gentherapie Recruiting
Halle (Saale), Germany
Contact: Haifa Al-Ali       haifa.al-ali@uk-halle.de   
Universitätsklinikum Jena Recruiting
Jena, Germany
Contact: Thomas Ernst       Thomas.Ernst@med.uni-jena.de   
Universitätsklinikum Leipzig Not yet recruiting
Leipzig, Germany
Universitaetsmedizin der Johannes Gutenberg-Universitaet Mainz Not yet recruiting
Mainz, Germany
Klinikum der Universitat Munchen Not yet recruiting
Munich, Germany
Universitätsklinikum Münster Medizinische Klinik A, Hämatologie, Hämostaseologi Recruiting
Münster, Germany
Contact: Christin Böwing    +49 251 8344386    christin.boewing@ukmuenster.de   
Robert-Bosch-Krankenhaus (RBK) Onkologisches Zentrum Recruiting
Stuttgart, Germany
Contact: Martin Kaufmann       martin.kaufmann@rbk.de   
Italy
AOU S. Luigi Gonzaga - Orbassano Recruiting
Orbassano, Turin, Italy
Contact: Silvia Marini, MD    +39 11 9026709    silvia.marini01@gmail.com   
Ospedale Mazzoni - UOC Ematologia Ascoli Piceno Recruiting
Ascoli Piceno, Italy
Contact: Piero Galieni       piero.galieni@sanita.marche.it   
Universita di Bologna Recruiting
Bologna, Italy
Contact: Antonio Curti       antonio.curti2@unibo.it   
Dipartimento di Oncologia Medica - IRST IRCC Recruiting
Meldola, Italy
Contact: Giovanni Martinelli       giovanni.martinelli@irst.emr.it   
Università degli Studi di Parma Recruiting
Parma, Italy
Contact: Giovanni Roti       giovanni.roti@unipr.it   
U.O. Ematologia Ravenna Recruiting
Ravenna, Italy
Contact: Francesco Lanza       Francesco.lanza@auslromagna.it   
Hospital Rimini Hematology, Department of Oncology and Hematoloy Recruiting
Rimini, Italy
Contact: Anna Maria Mianulli       annamaria.mianulli@auslromagna.it   
Umberto I Pol. di Roma-Università di Roma La Sapienza Not yet recruiting
Rome, Italy
Ospedale San Bortolo di Vicenza Recruiting
Vicenza, Italy
Contact: Eros Dibona       eros.dibona@aulss8.veneto.it   
Korea, Republic of
Kyungpook National University Hospital Recruiting
Daegu, Korea, Republic of, 700-721
Contact: Sang Kyun Sohn, MD    (82)-2-2228-5800      
Seoul National University Bundang Hospital Recruiting
Gumi, Korea, Republic of, 13620
Contact: Soo-Me Bang, MD    +82 1588-3369      
Seoul National University Hospital Recruiting
Seoul, Korea, Republic of, 03080
Contact: Sung-Soo Yoon, MD    +82-2-2072-0505      
Severance Hospital, Yonsei Health System Recruiting
Seoul, Korea, Republic of, 03722
Contact: June Won Cheong, MD    +82 53 200 2040      
Samsung Medical Center Recruiting
Seoul, Korea, Republic of, 06351
Contact: Chul Won Jung, MD    +82-2-3410-0200      
Spain
Hospital Vall d'Hebron Recruiting
Barcelona, Spain, 08035
Contact: Olga Salamero, MD    +34 934 89 48 94      
Hospital Clinic de Barcelona Recruiting
Barcelona, Spain, 8036
Contact: Jordi Esteve, MD    + 34 93 227 54 00      
Institut Català d'Oncologia-Hospital Duran i Reynals Recruiting
Barcelona, Spain, 8908
Contact: Montserrat Arnan-Sangerman, MD    +34 932 60 77 33      
Hospital de la Princesa Recruiting
Madrid, Spain, 28006
Contact: Angela Figuera       a.figueraalvarez@gmail.com   
Hospital Universitario 12 De Octubre Recruiting
Madrid, Spain, 28041
Contact: Joaquin Martinez Lopez, MD    +34 913 90 80 00      
START - Hospital Universitario Fundación Jiménez Díaz Not yet recruiting
Madrid, Spain
Hospital Clínico Universitario de Salamanca Recruiting
Salamanca, Spain, 37007
Contact: Vicente Vidriales       mbvidriales@saludcastillayleon.es   
Hospital Marques de Valdecilla Recruiting
Santander, Spain, 39008
Contact: Mercedes Colorado, MD    +34 942 20 25 20      
Hospital La Fe Recruiting
Valencia, Spain, 46026
Contact: Pau Montesinos, MD    +34 961 24 40 00      
United Kingdom
Clatterbridge Cancer Centre NHS Trust Recruiting
Liverpool, United Kingdom, L78XP
Contact: Amit Patel       amit.patel@liverpool.ac.uk   
University College London Hospitals NHS Foundation Trust Recruiting
London, United Kingdom, NW1 2PG
Contact: Alexandra Browndson    0203 456 7890      
St. George's University Hospital Recruiting
London, United Kingdom
Contact: Matthias Klammer       Matthias.Klammer@stgeorges.nhs.uk   
Churchill Hospital Recruiting
Oxford, United Kingdom
Contact: Lynn Quek       lynn.quek@ouh.nhs.uk   
Southampton General Hospital Recruiting
Southampton, United Kingdom
Contact: Christopher Dalley       Christopher.Dalley@uhs.nhs.uk   
Royal Marsden Hospital Recruiting
Sutton, United Kingdom, SM2 5PT
Contact: David Taussig, MD       HaematoOncRN@rmh.nhs.uk   
Sponsors and Collaborators
Forma Therapeutics, Inc.

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Responsible Party: Forma Therapeutics, Inc.
ClinicalTrials.gov Identifier: NCT02719574    
Other Study ID Numbers: 2102-HEM-101
First Posted: March 25, 2016    Key Record Dates
Last Update Posted: December 5, 2019
Last Verified: December 2019
Keywords provided by Forma Therapeutics, Inc.:
AML
MDS
IDH1
IDH
Additional relevant MeSH terms:
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Leukemia
Leukemia, Myeloid
Leukemia, Myeloid, Acute
Preleukemia
Myelodysplastic Syndromes
Neoplasms by Histologic Type
Neoplasms
Bone Marrow Diseases
Hematologic Diseases
Precancerous Conditions
Cytarabine
Azacitidine
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Antiviral Agents
Anti-Infective Agents
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Enzyme Inhibitors