Enasidenib

Generic Name: Enasidenib

Brand Names: Idhifa

Drug Type: Small Molecule

Chemical Formula: C_₁₉H_₁₇F_₆N_₇O

CAS Number: 1446502-11-9

Unique Ingredient Identifier: 3T1SS4E7AG

Background: Enasidenib is an orally available treatment for the treatment of adult patients with relapsed or refractory acute myeloid leukemia (AML) with specific mutations in the isocitrate dehydrogenase 2 (IDH2) gene, which is a recurrent mutation detected in 12-20% of adult patients with AML . Patients eligible for this treatment are selected by testing the presence ...

Indication: Indicated for the treatment of adult patients with relapsed or refractory acute myeloid leukemia (AML) with an isocitrate dehydrogenase-2 (IDH2) mutation.

Associated Conditions: Refractory Acute Myeloid Leukemia (AML), Relapsed Acute Myelogenous Leukemia (AML)

Associated Therapies: -

Clinical Trials

Decitabine/Cedazuridine and Venetoclax in Combination With Ivosidenib or Enasidenib for the Treatment of Relapsed or Refractory Acute Myeloid Leukemia

Phase 1

Recruiting

Conditions: Acute Myeloid Leukemia
Recurrent Acute Myeloid Leukemia
Refractory Acute Myeloid Leukemia

Interventions: Drug: Decitabine and Cedazuridine
Drug: Ivosidenib
Drug: Enasidenib
Drug: Venetoclax

First Posted Date: 2021-03-01

Last Posted Date: 2024-06-04

Lead Sponsor: M.D. Anderson Cancer Center

Target Recruit Count: 84

Registration Number: NCT04774393

Locations: 🇺🇸
M D Anderson Cancer Center, Houston, Texas, United States

Pharmacokinetics of Enasidenib (CC-90007) in Participants With Mild, Moderate and Severe Hepatic Impairment

Phase 1

Completed

Conditions: Hepatic Impairment

Interventions: Drug: Enasidenib

First Posted Date: 2020-10-05

Last Posted Date: 2024-07-15

Lead Sponsor: Celgene

Target Recruit Count: 40

Registration Number: NCT04573582

Locations: 🇺🇸
Local Institution - 002, Miami, Florida, United States
🇺🇸
Volunteer Research Group and New Orleans Center for Clinical Research - Knoxville, Knoxville, Tennessee, United States
🇺🇸
Local Institution - 003, Orlando, Florida, United States

IDH2-Post-Allo-Trial for Patients With IDH2-mut Myeloid Neoplasms After Allo-SCT

Phase 2

Active, not recruiting

Conditions: Leukemia, Myeloid, Acute
IDH2 R172
Myelodysplastic Syndromes
Chronic Myelomonocytic Leukemia
IDH2 Gene Mutation
IDH2 R140

Interventions: Drug: Enasidenib

First Posted Date: 2020-08-21

Last Posted Date: 2023-12-28

Lead Sponsor: Heinrich-Heine University, Duesseldorf

Target Recruit Count: 50

Registration Number: NCT04522895

Locations: 🇩🇪
Universitätsklinikum Heidelberg Innere Medizin V: Hämatologie, Onkologie und Rheumatologie, Heidelberg, Germany
🇩🇪
Universitätsklinikum Köln Klinik I für Innere Medizin, Köln, Germany
🇩🇪
Universitätsklinikum Leipzig Medizinische Klinik und Poliklinik I, Hämatologie und Zelltherapie, Leipzig, Germany

and more 8 locations

Bioavailability of Enasidenib (CC-90007) Sprinkle Formulation Relative to the Reference Tablet Formulation and Effect of Food on the Pharmacokinetics of Sprinkle Formulation in Healthy Adults

Phase 1

Completed

Conditions: Healthy Volunteers

Interventions: Drug: Enasidenib

First Posted Date: 2020-03-17

Last Posted Date: 2020-03-17

Lead Sponsor: Celgene

Target Recruit Count: 28

Registration Number: NCT04310527

Locations: 🇺🇸
PPD Development, LP, Austin, Texas, United States

Combined Ruxolitinib and Enasidenib in Patients With Accelerated/Blast-phase Myeloproliferative Neoplasm or Chronic-phase Myelofibrosis With an IDH2 Mutation

Phase 2

Completed

Conditions: Accelerated/Blast-phase Myeloproliferative Neoplasm
Chronic-phase Myelofibrosis
IDH2 Mutation

Interventions: Drug: Ruxolitinib
Drug: Enasidenib

First Posted Date: 2020-02-24

Last Posted Date: 2024-12-18

Lead Sponsor: John Mascarenhas

Target Recruit Count: 6

Registration Number: NCT04281498

Locations: 🇺🇸
Taussig Cancer Center Institute, Cleveland, Ohio, United States
🇺🇸
Memorial Sloan-Kettering Cancer Center, New York, New York, United States
🇺🇸
Icahn School of Medicine at Mount Sinai, New York, New York, United States

and more 8 locations

Enasidenib for the Treatment of Relapsed or Refractory Acute Myeloid Leukemia Patients With an IDH2 Mutation

Phase 2

Recruiting

Conditions: Recurrent Acute Myeloid Leukemia
Refractory Acute Myeloid Leukemia

Interventions: Procedure: Biospecimen Collection
Procedure: Bone Marrow Aspiration
Procedure: Bone Marrow Biopsy
Drug: Enasidenib
Drug: Enasidenib Mesylate

First Posted Date: 2019-12-18

Last Posted Date: 2024-12-04

Lead Sponsor: Children's Oncology Group

Target Recruit Count: 10

Registration Number: NCT04203316

Locations: 🇺🇸
Children's Hospital of Alabama, Birmingham, Alabama, United States
🇺🇸
Arkansas Children's Hospital, Little Rock, Arkansas, United States
🇺🇸
Children's Hospital Colorado, Aurora, Colorado, United States

and more 24 locations

Study of Enasidenib and Venetoclax in IDH2-Mutated Blood Cancers

Phase 1

Terminated

Conditions: Acute Myeloid Leukemia
Relapsed Cancer
Refractory Cancer
IDH2 Gene Mutation

Interventions: Drug: Enasidenib
Drug: Venetoclax

First Posted Date: 2019-09-17

Last Posted Date: 2024-01-24

Lead Sponsor: University Health Network, Toronto

Target Recruit Count: 27

Registration Number: NCT04092179

Locations: 🇨🇦
University of Alberta Hospital, Edmonton, Alberta, Canada
🇨🇦
Princess Margaret Cancer Centre, Toronto, Ontario, Canada

A Phase 1b Master Trial to Investigate CPX-351 in Subjects With Previously Untreated Acute Myeloid Leukemia

Phase 1

Completed

Conditions: Acute Myeloid Leukemia

Interventions: Drug: CPX-351
Drug: Venetoclax
Drug: Midostaurin
Drug: Enasidenib

First Posted Date: 2019-09-03

Last Posted Date: 2023-10-16

Lead Sponsor: Jazz Pharmaceuticals

Target Recruit Count: 57

Registration Number: NCT04075747

Locations: 🇺🇸
University of Kansas Cancer Center, Fairway, Kansas, United States
🇺🇸
University of Nebraska Medical Center, Omaha, Nebraska, United States
🇺🇸
Hackensack University Medical Center, Hackensack, New Jersey, United States

and more 7 locations

Enasidenib in Treating Patients With Relapsed or Refractory Acute Myeloid Leukemia With an IDH2 Gene Mutation

Phase 2

Withdrawn

Conditions: Bone Marrow Blasts Decreased by 50 Percent or More Compared to Pretreatment Level
Blasts Under 5 Percent of Peripheral Blood White Cells
IDH2 Gene Mutation
Recurrent Acute Myeloid Leukemia
Refractory Acute Myeloid Leukemia

Interventions: Drug: Enasidenib
Procedure: Hematopoietic Cell Transplantation

First Posted Date: 2019-03-19

Last Posted Date: 2021-03-10

Lead Sponsor: Roswell Park Cancer Institute

Registration Number: NCT03881735

Locations: 🇺🇸
Roswell Park Cancer Institute, Buffalo, New York, United States
🇺🇸
Cancer Institute at St Francis Hosptial, East Hills, New York, United States

Serial Measurements of Molecular and Architectural Responses to Therapy (SMMART) PRIME Trial

Phase 1

Terminated

Conditions: Accelerated Phase Chronic Myelogenous Leukemia, BCR-ABL1 Positive
Anatomic Stage IV Breast Cancer AJCC v8
Anemia
Ann Arbor Stage III Hodgkin Lymphoma
Ann Arbor Stage III Non-Hodgkin Lymphoma
Ann Arbor Stage IV Hodgkin Lymphoma
Ann Arbor Stage IV Non-Hodgkin Lymphoma
Atypical Chronic Myeloid Leukemia, BCR-ABL1 Negative
Blast Phase Chronic Myelogenous Leukemia, BCR-ABL1 Positive
Castration-Resistant Prostate Carcinoma

Interventions: Drug: Abemaciclib
Drug: Abiraterone
Drug: Afatinib
Biological: Bevacizumab
Drug: Bicalutamide
Procedure: Biospecimen Collection
Drug: Bortezomib
Drug: Cabazitaxel
Drug: Cabozantinib
Drug: Capecitabine
Drug: Carboplatin
Drug: Celecoxib
Drug: Cobimetinib
Drug: Copanlisib
Drug: Dabrafenib
Drug: Dacomitinib
Drug: Darolutamide
Drug: Dasatinib
Drug: Doxorubicin
Biological: Durvalumab
Drug: Enasidenib
Drug: Entrectinib
Drug: Enzalutamide
Drug: Erlotinib
Drug: Everolimus
Drug: Fluorouracil
Drug: Idelalisib
Drug: Imatinib
Biological: Ipilimumab
Drug: Lenvatinib
Drug: Leucovorin
Drug: Lorlatinib
Drug: Losartan
Drug: Nab-paclitaxel
Drug: Neratinib
Biological: Nivolumab
Drug: Olaparib
Drug: Oxaliplatin
Drug: Palbociclib
Drug: Panobinostat
Biological: Pembrolizumab
Biological: Pertuzumab
Drug: Ponatinib
Other: Quality-of-Life Assessment
Drug: Regorafenib
Drug: Ruxolitinib
Drug: Sirolimus
Drug: Sorafenib
Drug: Sunitinib
Drug: Trametinib
Biological: Trastuzumab Emtansine
Drug: Tretinoin
Drug: Vemurafenib
Drug: Venetoclax
Drug: Vismodegib
Drug: Vorinostat

First Posted Date: 2019-03-18

Last Posted Date: 2024-03-04

Lead Sponsor: OHSU Knight Cancer Institute

Target Recruit Count: 2

Registration Number: NCT03878524

Locations: 🇺🇸
OHSU Knight Cancer Institute, Portland, Oregon, United States

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