search
Back to results

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

Primary Purpose

Acute Myeloid Leukemia, Acute Myelogenous Leukemia, Myelodysplastic Syndrome

Status
Active
Phase
Phase 1
Locations
International
Study Type
Interventional
Intervention
FT-2102 (olutasidenib)
Azacitidine
Cytarabine
Sponsored by
Novo Nordisk A/S
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Acute Myeloid Leukemia focused on measuring AML, MDS, IDH1, IDH

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • UCLA Medical Center
  • UC Davis Comprehensive Cancer Center
  • Yale University
  • University of Miami
  • Emory Winship Cancer Institute
  • Northwestern University Feinberg School of Medicine
  • University of Maryland Greenebaum Cancer Center
  • Karmanos Cancer Institute
  • Roswell Park Cancer Institute
  • New York Medical College
  • Columbia University Medical Center
  • Cornell University Weill Medical College
  • Duke University Medical Center
  • The Ohio State University
  • Oregon Health & Science University
  • Sarah Cannon Research Institute - Tennessee Oncology
  • Vanderbilt University Medical Center
  • University of Texas Southwestern Medical Center
  • MD Anderson Cancer Center
  • Royal Adelaide Hospital
  • The Alfred Hospital
  • Victoria Cancer Care Center
  • Sir Charles Gairdner Hospital
  • Box Hill Hospital, Monash University and Eastern Health Clinical School
  • Princess Margaret Hospital
  • Service d'Hématologie Clinique, Hôpital Avicenne-APHP-Université Paris
  • Assistance Publique Hopitaux de Marseille (AP-HM) - Hopital Nord
  • Centre Hospitalier Universitaire Nantes
  • Hôpital Saint-Louis
  • Hopitaux Universitaires Est Parisien Hopital Saint-Antoine
  • Centre Hospitalier Universitaire (CHU) Bordeaux - Hospitaux du Haut Leveque
  • Centre Hospitalier Lyon Sud
  • University Hospital of Rennes
  • Institut Universitaire du Cancer Toulouse - Oncopole
  • Centre Hospitalier Universitaire de Nancy - Hopital Brabois
  • Institut de Cancérologie Gustave Roussy
  • Staedtisches Klinikum Braunschweig gGmbH
  • Universitaetsklinikum Giessen und Marburg GmbH - Klinik fuer Innere Medizin
  • Landeszentrum fuer Zell- und Gentherapie
  • Universitätsklinikum Münster Medizinische Klinik A, Hämatologie, Hämostaseologi
  • AOU S. Luigi Gonzaga - Orbassano
  • Ospedale Mazzoni - UOC Ematologia Ascoli Piceno
  • Universita di Bologna
  • Dipartimento di Oncologia Medica - IRST IRCC
  • Università degli Studi di Parma
  • U.O. Ematologia Ravenna
  • Hospital Rimini Hematology, Department of Oncology and Hematoloy
  • Seoul National University Bundang Hospital
  • Seoul National University Hospital
  • Hospital Vall d'Hebron
  • Hospital Clinic de Barcelona
  • Institut Català d'Oncologia-Hospital Duran i Reynals
  • Hospital Universitario 12 De Octubre
  • Hospital Clínico Universitario de Salamanca
  • Hospital La Fe
  • University College London Hospitals NHS Foundation Trust
  • St. George's University Hospital
  • Churchill Hospital
  • Southampton General Hospital
  • Royal Marsden Hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm 6

Arm 7

Arm 8

Arm 9

Arm 10

Arm 11

Arm Type

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Arm Label

PH1 Dose Escalation & Expansion FT-2102 (olutasidenib)

PH1 Esc. and Exp. FT-2102 (olutasidenib)+Azacitidine

PH1 Esc. and Exp. FT-2102 (olutasidenib)+Cytarabine

PH2 Cohort 1 FT-2102 (olutasidenib) Single Agent

PH2 Cohort 2 FT-2102 (olutasidenib) Single Agent

PH2 Cohort 3 FT-2102 (olutasidenib) Single Agent

PH2 Cohort 4 FT-2102 (olutasidenib)+Azacitidine

PH2 Cohort 5 FT-2102 (olutasidenib)+Azacitidine

PH2 Cohort 6 FT-2102 (olutasidenib)+Azacitidine

PH2 Cohort 7 FT-2102 (olutasidenib) Single Agent

PH2 Cohort 8 FT-2102 (olutasidenib)+Azacitidine

Arm Description

Relapsed or Refractory (R/R) AML

AML in morphologic complete remission or complete remission with incomplete blood count recovery (CR/CRi) after prior therapy with residual IDH1-R132 mutation

R/R AML/MDS, previously treated with FT-2102

R/R AML/MDS that are naïve to prior hypomethylating therapy and IDH1 inhibitor therapy

R/R AML/MDS that have inadequately responded to or have progressed on prior hypomethylating therapy

R/R AML/MDS that have been previously treated with single-agent FT-2102 as their last therapy prior to study enrollment

Treatment naïve AML for whom standard treatments are contraindicated

Treatment naïve AML who are candidates for azacitidine first line treatment

Outcomes

Primary Outcome Measures

Maximum Tolerated Doses (MTDs) or Maximum Evaluated Doses (MEDs) [Phase 1]
Number of Participants with a Dose Limiting Toxicity (DLT) [Phase 1]
Doses recommended for future studies [Phase 1]
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]
4-Month Relapse Free Survival (RFS) of FT-2102 (olutasidenib) single-agent [Phase 2 Cohort 2]

Secondary Outcome Measures

Area under the plasma concentration versus time curve (AUC) [Phase 1 and Phase 2]
Peak Plasma Concentration (Cmax) [Phase 1 and Phase 2]
Time of peak plasma concentration Tmax [Phase 1 and Phase 2]
Time for half of the drug to be absent in blood stream following dose (T 1/2) [Phase 1 and Phase 2]
Rate at which drug is removed from blood stream (CL/F) [Phase 1 and Phase 2]
Rate of drug distribution within the blood stream (Vd/F) [Phase 1 and Phase 2]
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]
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]
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 to Response (TTR) [Phase 2]
Duration of Response (DOR) [Phase 2]
Event-Free Survival (EFS) [Phase 2]
Overall Survival (OS) [Phase 2]
Relapse Free Survival (RFS) [Phase 2]

Full Information

First Posted
March 21, 2016
Last Updated
August 8, 2023
Sponsor
Novo Nordisk A/S
search

1. Study Identification

Unique Protocol Identification Number
NCT02719574
Brief Title
Open-label Study of FT-2102 With or Without Azacitidine or Cytarabine in Patients With AML or MDS With an IDH1 Mutation
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 Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
April 2016 (Actual)
Primary Completion Date
December 2023 (Anticipated)
Study Completion Date
February 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Novo Nordisk A/S

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Myeloid Leukemia, Acute Myelogenous Leukemia, Myelodysplastic Syndrome
Keywords
AML, MDS, IDH1, IDH

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
336 (Actual)

8. Arms, Groups, and Interventions

Arm Title
PH1 Dose Escalation & Expansion FT-2102 (olutasidenib)
Arm Type
Experimental
Arm Title
PH1 Esc. and Exp. FT-2102 (olutasidenib)+Azacitidine
Arm Type
Experimental
Arm Title
PH1 Esc. and Exp. FT-2102 (olutasidenib)+Cytarabine
Arm Type
Experimental
Arm Title
PH2 Cohort 1 FT-2102 (olutasidenib) Single Agent
Arm Type
Experimental
Arm Description
Relapsed or Refractory (R/R) AML
Arm Title
PH2 Cohort 2 FT-2102 (olutasidenib) Single Agent
Arm Type
Experimental
Arm Description
AML in morphologic complete remission or complete remission with incomplete blood count recovery (CR/CRi) after prior therapy with residual IDH1-R132 mutation
Arm Title
PH2 Cohort 3 FT-2102 (olutasidenib) Single Agent
Arm Type
Experimental
Arm Description
R/R AML/MDS, previously treated with FT-2102
Arm Title
PH2 Cohort 4 FT-2102 (olutasidenib)+Azacitidine
Arm Type
Experimental
Arm Description
R/R AML/MDS that are naïve to prior hypomethylating therapy and IDH1 inhibitor therapy
Arm Title
PH2 Cohort 5 FT-2102 (olutasidenib)+Azacitidine
Arm Type
Experimental
Arm Description
R/R AML/MDS that have inadequately responded to or have progressed on prior hypomethylating therapy
Arm Title
PH2 Cohort 6 FT-2102 (olutasidenib)+Azacitidine
Arm Type
Experimental
Arm Description
R/R AML/MDS that have been previously treated with single-agent FT-2102 as their last therapy prior to study enrollment
Arm Title
PH2 Cohort 7 FT-2102 (olutasidenib) Single Agent
Arm Type
Experimental
Arm Description
Treatment naïve AML for whom standard treatments are contraindicated
Arm Title
PH2 Cohort 8 FT-2102 (olutasidenib)+Azacitidine
Arm Type
Experimental
Arm Description
Treatment naïve AML who are candidates for azacitidine first line treatment
Intervention Type
Drug
Intervention Name(s)
FT-2102 (olutasidenib)
Intervention Description
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
Intervention Type
Drug
Intervention Name(s)
Azacitidine
Other Intervention Name(s)
Vidaza
Intervention Description
azacitidine will be administered per site's standard of care
Intervention Type
Drug
Intervention Name(s)
Cytarabine
Intervention Description
low-dose cytarabine will be administered per site's standard of care
Primary Outcome Measure Information:
Title
Maximum Tolerated Doses (MTDs) or Maximum Evaluated Doses (MEDs) [Phase 1]
Time Frame
Within first 4 weeks of treatment
Title
Number of Participants with a Dose Limiting Toxicity (DLT) [Phase 1]
Time Frame
Within first 4 weeks of treatment
Title
Doses recommended for future studies [Phase 1]
Time Frame
Within first 4 weeks of treatment
Title
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
Title
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 Measure Information:
Title
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
Title
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
Title
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
Title
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
Title
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
Title
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
Title
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
Title
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.
Title
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
Title
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
Title
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
Title
Event-Free Survival (EFS) [Phase 2]
Time Frame
From time of entry on study through progression, up to 30 weeks, on average
Title
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
Title
Relapse Free Survival (RFS) [Phase 2]
Time Frame
From time of entry on study through progression, up to 30 weeks, on average

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Emma Barrett
Organizational Affiliation
Novo Nordisk A/S
Official's Role
Study Director
Facility Information:
Facility Name
UCLA Medical Center
City
Los Angeles
State/Province
California
ZIP/Postal Code
90024
Country
United States
Facility Name
UC Davis Comprehensive Cancer Center
City
Sacramento
State/Province
California
ZIP/Postal Code
95817
Country
United States
Facility Name
Yale University
City
New Haven
State/Province
Connecticut
ZIP/Postal Code
06510
Country
United States
Facility Name
University of Miami
City
Miami
State/Province
Florida
ZIP/Postal Code
33136
Country
United States
Facility Name
Emory Winship Cancer Institute
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30322
Country
United States
Facility Name
Northwestern University Feinberg School of Medicine
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60611
Country
United States
Facility Name
University of Maryland Greenebaum Cancer Center
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21201
Country
United States
Facility Name
Karmanos Cancer Institute
City
Detroit
State/Province
Michigan
ZIP/Postal Code
48201
Country
United States
Facility Name
Roswell Park Cancer Institute
City
Buffalo
State/Province
New York
ZIP/Postal Code
14263
Country
United States
Facility Name
New York Medical College
City
Hawthorne
State/Province
New York
ZIP/Postal Code
10532
Country
United States
Facility Name
Columbia University Medical Center
City
New York
State/Province
New York
ZIP/Postal Code
10032
Country
United States
Facility Name
Cornell University Weill Medical College
City
New York
State/Province
New York
ZIP/Postal Code
10065
Country
United States
Facility Name
Duke University Medical Center
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27705
Country
United States
Facility Name
The Ohio State University
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43210
Country
United States
Facility Name
Oregon Health & Science University
City
Portland
State/Province
Oregon
ZIP/Postal Code
97229
Country
United States
Facility Name
Sarah Cannon Research Institute - Tennessee Oncology
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37203
Country
United States
Facility Name
Vanderbilt University Medical Center
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37232
Country
United States
Facility Name
University of Texas Southwestern Medical Center
City
Dallas
State/Province
Texas
ZIP/Postal Code
75390
Country
United States
Facility Name
MD Anderson Cancer Center
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
Royal Adelaide Hospital
City
Adelaide
State/Province
South Australia
ZIP/Postal Code
5000
Country
Australia
Facility Name
The Alfred Hospital
City
Melbourne
State/Province
Victoria
ZIP/Postal Code
3004
Country
Australia
Facility Name
Victoria Cancer Care Center
City
Parkville
State/Province
Victoria
ZIP/Postal Code
3000
Country
Australia
Facility Name
Sir Charles Gairdner Hospital
City
Nedlands
State/Province
Western Australia
ZIP/Postal Code
6009
Country
Australia
Facility Name
Box Hill Hospital, Monash University and Eastern Health Clinical School
City
Box Hill
ZIP/Postal Code
3128
Country
Australia
Facility Name
Princess Margaret Hospital
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5G 2M9
Country
Canada
Facility Name
Service d'Hématologie Clinique, Hôpital Avicenne-APHP-Université Paris
City
Bobigny
ZIP/Postal Code
93000
Country
France
Facility Name
Assistance Publique Hopitaux de Marseille (AP-HM) - Hopital Nord
City
Marseille
ZIP/Postal Code
13005
Country
France
Facility Name
Centre Hospitalier Universitaire Nantes
City
Nantes
ZIP/Postal Code
44093
Country
France
Facility Name
Hôpital Saint-Louis
City
Paris
ZIP/Postal Code
75010
Country
France
Facility Name
Hopitaux Universitaires Est Parisien Hopital Saint-Antoine
City
Paris
ZIP/Postal Code
75012
Country
France
Facility Name
Centre Hospitalier Universitaire (CHU) Bordeaux - Hospitaux du Haut Leveque
City
Pessac
ZIP/Postal Code
33604
Country
France
Facility Name
Centre Hospitalier Lyon Sud
City
Pierre-Bénite
ZIP/Postal Code
69495
Country
France
Facility Name
University Hospital of Rennes
City
Rennes
ZIP/Postal Code
35033
Country
France
Facility Name
Institut Universitaire du Cancer Toulouse - Oncopole
City
Toulouse
ZIP/Postal Code
31059
Country
France
Facility Name
Centre Hospitalier Universitaire de Nancy - Hopital Brabois
City
Vandœuvre-lès-Nancy
ZIP/Postal Code
54511
Country
France
Facility Name
Institut de Cancérologie Gustave Roussy
City
Villejuif
ZIP/Postal Code
94805
Country
France
Facility Name
Staedtisches Klinikum Braunschweig gGmbH
City
Braunschweig
Country
Germany
Facility Name
Universitaetsklinikum Giessen und Marburg GmbH - Klinik fuer Innere Medizin
City
Gießen
Country
Germany
Facility Name
Landeszentrum fuer Zell- und Gentherapie
City
Halle (Saale)
Country
Germany
Facility Name
Universitätsklinikum Münster Medizinische Klinik A, Hämatologie, Hämostaseologi
City
Münster
Country
Germany
Facility Name
AOU S. Luigi Gonzaga - Orbassano
City
Orbassano
State/Province
Turin
Country
Italy
Facility Name
Ospedale Mazzoni - UOC Ematologia Ascoli Piceno
City
Ascoli Piceno
Country
Italy
Facility Name
Universita di Bologna
City
Bologna
Country
Italy
Facility Name
Dipartimento di Oncologia Medica - IRST IRCC
City
Meldola
Country
Italy
Facility Name
Università degli Studi di Parma
City
Parma
Country
Italy
Facility Name
U.O. Ematologia Ravenna
City
Ravenna
Country
Italy
Facility Name
Hospital Rimini Hematology, Department of Oncology and Hematoloy
City
Rimini
Country
Italy
Facility Name
Seoul National University Bundang Hospital
City
Gumi
ZIP/Postal Code
13620
Country
Korea, Republic of
Facility Name
Seoul National University Hospital
City
Seoul
ZIP/Postal Code
03080
Country
Korea, Republic of
Facility Name
Hospital Vall d'Hebron
City
Barcelona
ZIP/Postal Code
08035
Country
Spain
Facility Name
Hospital Clinic de Barcelona
City
Barcelona
ZIP/Postal Code
8036
Country
Spain
Facility Name
Institut Català d'Oncologia-Hospital Duran i Reynals
City
Barcelona
ZIP/Postal Code
8908
Country
Spain
Facility Name
Hospital Universitario 12 De Octubre
City
Madrid
ZIP/Postal Code
28041
Country
Spain
Facility Name
Hospital Clínico Universitario de Salamanca
City
Salamanca
ZIP/Postal Code
37007
Country
Spain
Facility Name
Hospital La Fe
City
Valencia
ZIP/Postal Code
46026
Country
Spain
Facility Name
University College London Hospitals NHS Foundation Trust
City
London
ZIP/Postal Code
NW1 2PG
Country
United Kingdom
Facility Name
St. George's University Hospital
City
London
Country
United Kingdom
Facility Name
Churchill Hospital
City
Oxford
Country
United Kingdom
Facility Name
Southampton General Hospital
City
Southampton
Country
United Kingdom
Facility Name
Royal Marsden Hospital
City
Sutton
ZIP/Postal Code
SM2 5PT
Country
United Kingdom

12. IPD Sharing Statement

Citations:
PubMed Identifier
36370742
Citation
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. Erratum In: Lancet Haematol. 2023 Jan;10(1):e9.
Results Reference
derived

Learn more about this trial

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

We'll reach out to this number within 24 hrs