Epacadostat

Generic Name: Epacadostat

Drug Type: Small Molecule

Chemical Formula: C_₁₁H_₁₃BrFN_₇O_₄S

CAS Number: 1204669-58-8

Unique Ingredient Identifier: 71596A9R13

Background: Epacadostat has been used in trials studying the treatment of HL, Melanoma, Glioblastoma, Mucosal Melanoma, and Ovarian Carcinoma, among others.

Clinical Trials

Phase I/II Study of Immunotherapy Combination BN-Brachyury Vaccine, M7824, N-803 and Epacadostat (QuEST1)

Phase 1

Completed

Conditions: Prostate Cancer
Solid Tumor
Metastatic Prostate Cancer
Advanced Solid Tumor
Prostate Neoplasm

Interventions: Biological: M7824
Drug: N-803
Biological: MVA-BN-Brachyury
Biological: FPV-Brachyury
Drug: Epacadostat

First Posted Date: 2018-04-11

Last Posted Date: 2024-11-25

Lead Sponsor: National Cancer Institute (NCI)

Target Recruit Count: 53

Registration Number: NCT03493945

Locations: 🇺🇸
National Institutes of Health Clinical Center, Bethesda, Maryland, United States

Epacadostat, Cladribine and Cytarabine (ECC) in AML

Phase 1

Withdrawn

Conditions: Relapse
AML

Interventions: Drug: Epacadostat
Drug: Cladribine
Drug: Cytarabine

First Posted Date: 2018-04-09

Last Posted Date: 2018-09-11

Lead Sponsor: Insel Gruppe AG, University Hospital Bern

Registration Number: NCT03491579

Locations: 🇨🇭
Departement of Medical Oncology, University Hospital Berne, Berne, Switzerland

A Window of Opportunity Study to Investigate Mechanisms of Actions of Novel Therapeutic Agents in Patients With Resectable Solid Tumor Malignancies

Phase 1

Terminated

Conditions: Solid Tumor

Interventions: Drug: Epacadostat

First Posted Date: 2018-03-20

Last Posted Date: 2021-08-26

Lead Sponsor: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Target Recruit Count: 2

Registration Number: NCT03471286

Locations: 🇺🇸
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins, Baltimore, Maryland, United States

Epacadostat and Pembrolizumab in Patients With Head and Neck Cancer That Have Failed Prior Immunotherapy

Phase 2

Terminated

Conditions: Head and Neck Cancer
Head and Neck Squamous Cell Carcinoma

Interventions: Drug: Pembrolizumab
Drug: Epacadostat

First Posted Date: 2018-03-13

Last Posted Date: 2020-01-27

Lead Sponsor: University of Chicago

Target Recruit Count: 2

Registration Number: NCT03463161

Locations: 🇺🇸
University of Chicago Medical Center, Chicago, Illinois, United States

Epacadostat, Idarubicin and Cytarabine (EIC) in AML

Phase 1

Withdrawn

Conditions: AML

Interventions: Drug: Epacadostat
Drug: Idarubicin
Drug: Cytarabine
Drug: Daunorubicin

First Posted Date: 2018-02-23

Last Posted Date: 2018-09-11

Lead Sponsor: Insel Gruppe AG, University Hospital Bern

Registration Number: NCT03444649

Locations: 🇨🇭
Departement of Medical Oncology, University Hospital Berne, Berne, Switzerland

Epacadostat and Pembrolizumab in Treating Participants With Advanced Pancreatic Cancer

Phase 2

Withdrawn

Conditions: ATM Gene Mutation
Deleterious BRCA1 Gene Mutation
Deleterious BRCA2 Gene Mutation
Homologous Recombination Deficiency
Pancreatic Ductal Adenocarcinoma
Stage II Pancreatic Cancer AJCC v8
Stage IIA Pancreatic Cancer AJCC v8
Stage IIB Pancreatic Cancer AJCC v8
Stage III Pancreatic Cancer AJCC v8
Stage IV Pancreatic Cancer AJCC v8

Interventions: Drug: Epacadostat
Biological: Pembrolizumab

First Posted Date: 2018-02-14

Last Posted Date: 2019-05-30

Lead Sponsor: M.D. Anderson Cancer Center

Registration Number: NCT03432676

A Study of Epacadostat, an IDO1 Inhibitor, in Combination With Pembrolizumab in Patients With Metastatic and/or Locally Advanced Sarcoma

Phase 2

Active, not recruiting

Conditions: Sarcoma

Interventions: Drug: Epacadostat
Drug: Pembrolizumab

First Posted Date: 2018-01-29

Last Posted Date: 2025-05-02

Lead Sponsor: Memorial Sloan Kettering Cancer Center

Target Recruit Count: 30

Registration Number: NCT03414229

Locations: 🇺🇸
Memorial Sloan Kettering Cancer Center, New York, New York, United States

ALCMI-005: Pembrolizumab and Epacadostat in Treating Patients With Extensive Stage Small Cell Lung Cancer

Phase 2

Withdrawn

Conditions: Extensive Stage Small Cell Lung Carcinoma

Interventions: Biological: Pembrolizumab
Drug: Epacadostat
Other: Laboratory Biomarker Analysis

First Posted Date: 2018-01-18

Last Posted Date: 2018-10-10

Lead Sponsor: City of Hope Medical Center

Registration Number: NCT03402880

Locations: 🇺🇸
City of Hope Medical Center, Duarte, California, United States
🇺🇸
City of Hope South Pasadena, South Pasadena, California, United States
🇺🇸
Dana-Farber Cancer Institute, Boston, Massachusetts, United States

Pembrolizumab + Epacadostat vs Pembrolizumab + Placebo in Recurrent or Progressive Metastatic Urothelial Carcinoma

Phase 3

Completed

Conditions: UC (Urothelial Cancer)

Interventions: Drug: Pembrolizumab
Drug: Epacadostat
Drug: Placebo

First Posted Date: 2017-12-15

Last Posted Date: 2021-11-30

Lead Sponsor: Incyte Corporation

Target Recruit Count: 84

Registration Number: NCT03374488

Locations: 🇫🇷
Centre de Lutte Contre le Cancer Francois Baclesse, Caen, France
🇫🇷
Clinique Victor Hugo, Le Mans, France
🇫🇷
Centre Leon Berard, Lyon, France

and more 132 locations

Pembrolizumab in Combination With Epacadostat or Placebo in Cisplatin-ineligible Urothelial Carcinoma (KEYNOTE-672/ECHO-307)

Phase 3

Completed

Conditions: UC (Urothelial Cancer)

Interventions: Drug: Pembrolizumab
Drug: Epacadostat
Drug: Placebo

First Posted Date: 2017-12-05

Last Posted Date: 2021-12-16

Lead Sponsor: Incyte Corporation

Target Recruit Count: 93

Registration Number: NCT03361865

Locations: 🇺🇸
University of California Irvine Medical Center, Orange, California, United States
🇺🇸
Yale Cancer Center, New Haven, Connecticut, United States
🇺🇸
University of Tennessee Medical Center Knoxville, Knoxville, Tennessee, United States

and more 140 locations

Drug Development Updates

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