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

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

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.

Study Overview

• Status: Completed
• Conditions: Acute Myeloid Leukemia; Myelodysplastic Syndrome; Acute Myelogenous Leukemia
• Intervention / Treatment: Drug: FT-2102 (olutasidenib); Drug: Azacitidine; Drug: Cytarabine

• Study Type: Interventional
• Enrollment (Actual): 336
• Phase: Phase 2; Phase 1

Contacts and Locations

Study Locations

• Australia
  • Box Hill, Australia, 3128
    • Box Hill Hospital, Monash University and Eastern Health Clinical School
  • South Australia
    • Adelaide, South Australia, Australia, 5000
      • Royal Adelaide Hospital
  • Victoria
    • Melbourne, Victoria, Australia, 3004
      • The Alfred Hospital
    • Parkville, Victoria, Australia, 3000
      • Victoria Cancer Care Center
  • Western Australia
    • Nedlands, Western Australia, Australia, 6009
      • Sir Charles Gairdner Hospital
• Canada
  • Ontario
    • Toronto, Ontario, Canada, M5G 2M9
      • Princess Margaret Hospital
• France
  • Bobigny, France, 93000
    • Service d'Hématologie Clinique, Hôpital Avicenne-APHP-Université Paris
  • Marseille, France, 13005
    • Assistance Publique Hopitaux de Marseille (AP-HM) - Hopital Nord
  • Nantes, France, 44093
    • Centre Hospitalier Universitaire Nantes
  • Paris, France, 75010
    • Hôpital Saint-Louis
  • Paris, France, 75012
    • Hopitaux Universitaires Est Parisien Hopital Saint-Antoine
  • Pessac, France, 33604
    • Centre Hospitalier Universitaire (CHU) Bordeaux - Hospitaux du Haut Leveque
  • Pierre-Bénite, France, 69495
    • Centre Hospitalier Lyon Sud
  • Rennes, France, 35033
    • University Hospital of Rennes
  • Toulouse, France, 31059
    • Institut Universitaire du Cancer Toulouse - Oncopole
  • Vandœuvre-lès-Nancy, France, 54511
    • Centre Hospitalier Universitaire de Nancy - Hopital Brabois
  • Villejuif, France, 94805
    • Institut de Cancérologie Gustave Roussy
• Germany
  • Braunschweig, Germany
    • Staedtisches Klinikum Braunschweig Ggmbh
  • Gießen, Germany
    • Universitaetsklinikum Giessen und Marburg GmbH - Klinik fuer Innere Medizin
  • Halle (Saale), Germany
    • Landeszentrum fuer Zell- und Gentherapie
  • Münster, Germany
    • Universitätsklinikum Münster Medizinische Klinik A, Hämatologie, Hämostaseologi
• Italy
  • Ascoli Piceno, Italy
    • Ospedale Mazzoni - UOC Ematologia Ascoli Piceno
  • Bologna, Italy
    • Universita di Bologna
  • Meldola, Italy
    • Dipartimento di Oncologia Medica - IRST IRCC
  • Parma, Italy
    • Università degli Studi di Parma
  • Ravenna, Italy
    • U.O. Ematologia Ravenna
  • Rimini, Italy
    • Hospital Rimini Hematology, Department of Oncology and Hematoloy
  • Turin
    • Orbassano, Turin, Italy
      • AOU S. Luigi Gonzaga - Orbassano
• Korea, Republic of
  • Gumi, Korea, Republic of, 13620
    • Seoul National University Bundang Hospital
  • Seoul, Korea, Republic of, 03080
    • Seoul National University Hospital
• Spain
  • Barcelona, Spain, 08035
    • Hospital Vall d'Hebron
  • Barcelona, Spain, 8036
    • Hospital Clinic de Barcelona
  • Barcelona, Spain, 8908
    • Institut Catala d'Oncologia-Hospital Duran i Reynals
  • Madrid, Spain, 28041
    • Hospital Universitario 12 de Octubre
  • Salamanca, Spain, 37007
    • Hospital Clínico Universitario de Salamanca
  • Valencia, Spain, 46026
    • Hospital la Fé
• United Kingdom
  • London, United Kingdom, NW1 2PG
    • University College London Hospitals NHS Foundation Trust
  • London, United Kingdom
    • St. George's University Hospital
  • Oxford, United Kingdom
    • Churchill Hospital
  • Southampton, United Kingdom
    • Southampton General Hospital
  • Sutton, United Kingdom, SM2 5PT
    • Royal Marsden Hospital
• United States
  • California
    • Los Angeles, California, United States, 90024
      • UCLA Medical Center
    • Sacramento, California, United States, 95817
      • UC Davis Comprehensive Cancer Center
  • Connecticut
    • New Haven, Connecticut, United States, 06510
      • Yale University
  • Florida
    • Miami, Florida, United States, 33136
      • University of Miami
  • Georgia
    • Atlanta, Georgia, United States, 30322
      • Emory Winship Cancer Institute
  • Illinois
    • Chicago, Illinois, United States, 60611
      • Northwestern University Feinberg School of Medicine
  • Maryland
    • Baltimore, Maryland, United States, 21201
      • University of Maryland Greenebaum Cancer Center
  • Michigan
    • Detroit, Michigan, United States, 48201
      • Karmanos Cancer Institute
  • New York
    • Buffalo, New York, United States, 14263
      • Roswell Park Cancer Institute
    • Hawthorne, New York, United States, 10532
      • New York Medical College
    • New York, New York, United States, 10032
      • Columbia University Medical Center
    • New York, New York, United States, 10065
      • Cornell University Weill Medical College
  • North Carolina
    • Durham, North Carolina, United States, 27705
      • Duke University Medical Center
  • Ohio
    • Columbus, Ohio, United States, 43210
      • The Ohio State University
  • Oregon
    • Portland, Oregon, United States, 97229
      • Oregon Health & Science University
  • Tennessee
    • Nashville, Tennessee, United States, 37232
      • Vanderbilt University Medical Center
    • Nashville, Tennessee, United States, 37203
      • Sarah Cannon Research Institute - Tennessee Oncology
  • Texas
    • Dallas, Texas, United States, 75390
      • University of Texas Southwestern Medical Center
    • Houston, Texas, United States, 77030
      • MD Anderson Cancer Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

11

Arms and Interventions

Participant Group / 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 Names: 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 FT-2102	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 Names: 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 Names: Vidaza
Experimental: PH2 Cohort 6 FT-2102 (olutasidenib)+Azacitidine; R/R AML/MDS that have been previously treated with single-agent FT-2102 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 Names: 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 Names: Vidaza

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Phase 1: Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)	A TEAE was defined as an adverse event (AE) that emerges during treatment, having been absent pre-treatment, or worsens relative to the pre-treatment state. An AE was defined as any unfavourable and unintended sign (including an abnormal laboratory finding), symptom or disease temporally associated with the use of a product, whether or not considered related to the product. A serious adverse event (SAE) is defined as any untoward medical occurrence that at any dose results in death, or is life-threatening, or requires inpatient hospitalization or causes prolongation of existing hospitalization results in persistent or significant disability/incapacity, or may have caused a congenital anomaly/birth defect, or requires intervention to prevent permanent impairment or damage. Number of participants with TEAEs and SAEs is reported. Safety analysis set (SAS) included all the participants who have received at least one dose of study drug (FT-2102, azacitidine, or cytarabine).	Phase 1: From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
Phase 1: Number of Participants With Change From Baseline in Clinically Significant Abnormal Laboratory Values	Number of participants with change from baseline in clinically significant abnormal laboratory values for hematology, chemistry and coagulation with Grade <1 to 4 is reported. National Cancer Institute - Common Terminology Criteria for Adverse Events (NCI-CTCAE) version 4.03 toxicity grade used to determine severity of AE. Grade 1: mild;asymptomatic/mild symptoms; Grade 2: moderate; minimal; Grade 3: severe/medically significant; Grade 4: life-threatening consequences, Grade 5: death.	Phase 1: From Baseline up to 28 days after last dose of study drug (up to 82 months)
Phase 1: Number of Participants With Change From Baseline in Clinically Significant Abnormal Electrocardiogram (ECG)	Number of participants with change from baseline in clinically significant abnormal ECG parameter (QTcF) is reported. QT interval was the time between the start of the Q wave and the end of the T wave in the cardiac electrical cycle. QTcF was the QT interval corrected for heart rate using Fridericia's formula: QTcF = QT divided by cube root of 60/heart rate.	Phase 1: From Baseline up to 28 days after last dose of study drug (up to 82 months)
Phase 2, Cohort 1: Percentage of Participants With Complete Remission (CR) Plus Complete Remission With Partial Hematological Recovery (CRh) for Acute Myeloid Leukemia Assessed by Investigator Based on International Working Group (IWG) Response Criteria	Percentage of participants with CR plus CRh (CR, Molecular CR [CRm], Cytogenetic CR [CRc], CRh) is re-ported. CR is defined as bone marrow blasts less than (<) 5 percent (%) (in aspirate with spicules and 200 nucleated cells), no blasts with auer rods, no extramedullary disease, absolute neutrophil count (ANC) greater than or equal to (>=) 1000/μL, platelet count >=100,000/μL and transfusion independ-ence. CRc is defined as CR with no residual cytogenetic abnormalities. CRm is defined as CR with unde-tectable IDH1m minimal residual disease (MRD) and CRh is defined as bone marrow blasts and partial recovery of peripheral blood counts (platelet count >50 × 10^9/L and ANC > 0.5 × 10^9/L).	Phase 2: up to 3 weeks post last dose of study drug or until the introduction of new anticancer therapy, whichever is earlier (up to 82 months)
Phase 2, Cohort 3, 4, 5, 6, 7, 8: Percentage of Participants With CR Plus CRh for Acute Myeloid Leukemia Assessed by Investigator Based on IWG Response Criteria	Percentage of participants with CR plus CRh (CR, Molecular CR [CRm]), Cytogenetic CR [CRc], CRh) is re-ported. CR is defined as bone marrow blasts <5 % (in aspirate with spicules and 200 nucleated cells), no blasts with auer rods, no extramedullary disease, ANC >=1000/μL, platelet count >=100,000/μL and transfusion independ-ence. CRc is defined as CR with no residual cytogenetic abnormalities. CRm is de-fined as CR with undetectable IDH1m MRD and CRh is defined as bone marrow blasts and partial recovery of peripheral blood counts (platelet count >50 × 10^9/L and ANC > 0.5 × 10^9/L).	Phase 2: up to 3 weeks post last dose of study drug or until the introduction of new anticancer therapy, whichever is earlier (up to 82 months)
Phase 2, Cohort 4 and 5: Percentage of Participants With CR for MDS Assessed by IWG Response Criteria	Percentage of participants with complete remission (CR) is reported. CR is defined as bone marrow blast ≤ 5% myeloblasts with normal maturation of all cell lines, peripheral blood: Hgb ≥11 grams per deciliter (g/dL), platelets ≥ 100 × 10^9/L, neutrophils ≥ 1.0 × 10^9/L and blasts 0%.	Phase 2: up to 3 weeks post last dose of study drug or until the introduction of new anticancer therapy, whichever is earlier (up to 82 months)
Phase 2, Cohort 2: Four-month Relapse Free Survival (RFS) Rate	RFS is defined as the time between the date of first dose until relapse or death from any cause, whichever occurs first. RFS is calculated for all participants in Phase 2 Cohort 2. 4-Month RFS rate is defined as the percentage of participants in Phase 2 Cohort 2 who have not relapsed or died on or before their 4-month response evaluation.	Phase 2: From the date of first dose until relapse or death from any cause, whichever occurs first (up to 4 months)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Phase 1: Area Under the Curve (AUClast) for FT-2102	Area under the plasma concentration-time curve from zero time until the last measurable concentration is presented.	Phase 1: Cycle 1 Day 1 and Cycle 2 Day 1 (Cycle length= 28 days)
Phase 1: Maximum Plasma Concentration (Cmax) for FT-2102	Maximum plasma concentration (Cmax) for FT-2102 is presented.	Phase 1: Cycle 1 Day 1 and Cycle 2 Day 1 (Cycle length= 28 days)
Phase 1: Time to Maximum Plasma Concentration (Tmax) for FT-2102	Time to reach the maximum plasma concentration (Tmax) is presented.	Phase 1: Cycle 1 Day 1 and Cycle 2 Day 1 (Cycle length= 28 days)
Phase 1: Time to Response (TTR) for AML	TTR is the time in months between the first dose of study drug and documentation of the first overall response for participants who achieve a PR or better. This analysis was performed only on participants who have achieved PR or better as a best overall response.	Phase 1: Time from first dose of study drug until documentation of the first overall response (up to 82 months)
Phase 1: Duration of Overall Response for AML	Duration of response is defined as the time from the date of the first response to the date of the relapse or death. The estimation of median duration of overall response was done by Kaplan-Meier method.	Phase 1: From date of the first response to the date of the relapse or death (up to 82 months)
Phase 1: Time to Response (TTR ) for MDS	TTR is the time in months between the first dose of study drug and documentation of the first overall response for participants who achieve a PR or better. This analysis was performed only on participants who have achieved PR or better as a best overall response.	Phase 1: Time from first dose of study drug until documentation of the first overall response (up to 82 months)
Phase 2: Time to Response (TTR) for Acute Myeloid Leukemia (AML)	TTR is the time in months between the first dose of study drug and documentation of the first overall response for participants who achieve a PR or better. This analysis was performed only on participants who have achieved PR or better as a best overall response.	Phase 2: Time from first dose of study drug until documentation of the first overall response (up to 82 months)
Phase 2: Duration of Overall Response for Acute Myeloid Leukemia (AML)	Duration of overall response is defined as the time from the date of the first response to the date of the relapse or death. The estimation of median duration of overall response was done by Kaplan-Meier method.	Phase 2: From the date of the first response to the date of the relapse or death (up to 82 months)
Phase 2, Cohort 4 and Cohort 5: Time to Response (TTR) for Myelodysplastic Syndrome (MDS)	TTR is the time in months between the first dose of study drug and documentation of the first overall response for participants who achieve a PR or better. This analysis was performed only on participants who have achieved PR or better as a best overall response.	Phase 2: Time from first dose of study drug until documentation of the first overall response (up to 82 months)
Phase 2, Cohort 4 and Cohort 5: Duration of Overall Response for Myelodysplastic Syndrome (MDS)	Duration of overall response was calculated similarly to DCR but was assessed the time in months between documentation of the first response of PR or better until the date of relapse, death, whichever is earlier. The estimation of median duration of overall response was done by Kaplan-Meier method. The median duration of overall response is defined as the time at which 50% of the participants in a study have experienced the event of interest (relapse or death). Given the presence of only a single participant in the sample, there is an absence of variability in outcomes, and therefore, it was not possible to ascertain a time point at which half of the participants have experienced the event. Hence, median value could not be calculated.	Phase 2: From the documentation of the first response of PR or better until the date of relapse, death, whichever is earlier (up to 82 months)
Phase 2, Cohort 2: Time to Relapse-Free Survival (RFS)	RFS was calculated for all participants in Phase 2 Cohort 2. RFS is defined as the time (in months) between the date of first dose until relapse or death from any cause, whichever occurs first. Relapse free survival time to event is reported for all participants in Cohort 2.	Phase 2: From the date of first dose until relapse or death from any cause, whichever occurs first (up to 82 months)
Phase 2: Overall Survival (OS)	OS is defined as the time in months from the first dose of study drug until death from any cause. For the participants who are not known to have died by the end of study follow-up, OS will be censored on the date the participants was last known to be alive. OS is calculated using Kaplan-Meier method.	Phase 2: From first dose of study drug until death from any cause (up to 82 months)
Phase 2: Event-free Survival (EFS)	EFS is defined as the time in months between first dose of study drug and disease progression, relapse, death from any cause, treatment failure, or start of other (non-protocol study drug) new antileukemia therapy, whichever occurs first.	Phase 2: From first dose of study drug to disease progression, relapse, death from any cause, treatment failure, or start of other (non-protocol study drug) new antileukemia therapy (up to 82 months)
Phase 2: Transfusion Independence	Transfusion independence is defined as the number of participants who experience at least a 56-day period during any point on treatment without requiring a transfusion of RBC and/or platelet transfusion. Participants are classified as either "dependent" or "independent" at baseline based on their transfusion history. Those who received either platelets or pRBC or both within 8 weeks prior to the first dose of FT-2102 are considered "dependent". Number of participants with transfusion independent is reported here.	Phase 2: From baseline (8 weeks prior to first dose) up to treatment period (up to 82 months)
Phase 2: Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)	A TEAE was defined as an AE that emerges during treatment, having been absent pre-treatment, or worsens relative to the pre-treatment state. An AE was defined as any unfavourable and unintended sign (including an abnormal laboratory finding), symptom or disease temporally associated with the use of a product, whether or not considered related to the product. A SAE is defined as any untoward medical occur-rence that at any dose results in death, or is life-threatening, or requires inpatient hospitalization or causes prolongation of existing hospitalization results in persistent or significant disability/incapacity, or may have caused a congenital anomaly/birth defect, or requires intervention to prevent permanent impairment or damage. Number of participants with TEAEs and SAEs is reported.	Phase 2: From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
Phase 2: Number of Participants With Change From Baseline in Clinically Significant Abnormal Laboratory Values	Number of participants with change from baseline in clinically significant abnormal laboratory values for hematology, chemistry and coagulation with Grade <1 to 4 is reported. National Cancer Institute - Common Terminology Criteria for Adverse Events (NCI-CTCAE) version 4.03 toxicity grade used to determine severity of AE. Grade 1: mild;asymptomatic/mild symptoms; Grade 2: moderate; minimal; Grade 3: severe/medically significant; Grade 4: life-threatening consequences, Grade 5: death.	Phase 2: From Baseline up to 28 days after last dose of study drug (up to 82 months)
Phase 2: Number of Participants With Change From Baseline in Clinically Significant Abnormal Electrocardiogram (ECG)	Number of participants with change from baseline in clinically significant abnormal ECG parameter (QTcF) is reported. QT interval was the time between the start of the Q wave and the end of the T wave in the cardiac electrical cycle. QTcF was the QT interval corrected for heart rate using Fridericia's formula: QTcF = QT divided by cube root of 60/heart rate.	Phase 2: From Baseline up to 28 days after last dose of study drug (up to 82 months)
Phase 2: Area Under the Curve (AUClast) for FT-2102	Area under the plasma concentration-time curve from zero time until the last measurable concentration is presented.	Phase 2: Cycle 1 Day 1 and Cycle 2 Day 1 (Cycle length= 28 days)
Phase 2: Maximum Plasma Concentration (Cmax) for FT-2102	Maximum Plasma Concentartion (Cmax) for FT-2102 is presented.	Phase 2: Cycle 1 Day 1 and Cycle 2 Day 1 (Cycle length= 28 days)
Phase 2: Time to Maximum Plasma Concentration (Tmax) for FT-2102	Time to reach the maximum plasma concentration (Tmax) for FT-2102 is presented.	Phase 2: Cycle 1 Day 1 and Cycle 2 Day 1 (Cycle length= 28 days)

Collaborators and Investigators

• Sponsor: Forma Therapeutics, Inc.
• Investigators: Study Director: Clinical Transparency (dept. 2834), Novo Nordisk A/S

Publications and helpful links

General Publications

• Watts JM, Baer MR, Yang J, Prebet T, Lee S, Schiller GJ, Dinner SN, Pigneux A, Montesinos P, Wang ES, Seiter KP, Wei AH, De Botton S, Arnan M, Donnellan W, Schwarer AP, Recher C, Jonas BA, Ferrell PB Jr, Marzac C, Kelly P, Sweeney J, Forsyth S, Guichard SM, Brevard J, Henrick P, Mohamed H, Cortes JE. Olutasidenib alone or with azacitidine in IDH1-mutated acute myeloid leukaemia and myelodysplastic syndrome: phase 1 results of a phase 1/2 trial. Lancet Haematol. 2023 Jan;10(1):e46-e58. doi: 10.1016/S2352-3026(22)00292-7. Epub 2022 Nov 10.

Study record dates

Study Major Dates

• Study Start (Actual): April 30, 2016
• Primary Completion (Actual): December 28, 2023
• Study Completion (Actual): January 24, 2024

Study Registration Dates

• First Submitted: March 21, 2016
• First Submitted That Met QC Criteria: March 21, 2016
• First Posted (Estimated): March 25, 2016

Study Record Updates

• Last Update Posted (Actual): June 26, 2025
• Last Update Submitted That Met QC Criteria: June 6, 2025
• Last Verified: June 1, 2025

More Information

Terms related to this study

• Keywords: AML; MDS; IDH; IDH1
• Additional Relevant MeSH Terms: Neoplasms; Neoplasms by Histologic Type; Hematologic Diseases; Precancerous Conditions; Bone Marrow Diseases; Leukemia; Leukemia, Myeloid; Leukemia, Myeloid, Acute; Preleukemia; Myelodysplastic Syndromes; Anti-Infective Agents; Antineoplastic Agents; Immunosuppressive Agents; Immunologic Factors; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Antimetabolites, Antineoplastic; Antimetabolites; Antiviral Agents; Cytarabine; Azacitidine
• Other Study ID Numbers: 2102-HEM-101