Pevonedistat

Generic Name: Pevonedistat

Drug Type: Small Molecule

Chemical Formula: C_₂₁H_₂₅N_₅O_₄S

CAS Number: 905579-51-3

Unique Ingredient Identifier: S3AZD8D215

Background: Pevonedistat has been used in trials studying the treatment of Lymphoma, Solid Tumors, Multiple Myeloma, Hodgkin Lymphoma, and Metastatic Melanoma, among others.

Clinical Trials

A Study of Pevonedistat Combined With Decitabine and Cedazuridine in Adults With Higher-risk Myelodysplastic Syndromes

Phase 2

Withdrawn

Conditions: Myelodysplastic Syndromes (MDS)

Interventions: Drug: Pevonedistat
Drug: Decitabine
Drug: Cedazuridine

First Posted Date: 2021-08-02

Last Posted Date: 2021-09-29

Lead Sponsor: Takeda

Registration Number: NCT04985656

Pevonedistat and Pembrolizumab for the Treatment of dMMR/MSI-H Metastatic or Locally Advanced Unresectable Solid Tumor

Phase 1

Terminated

Conditions: Unresectable Malignant Solid Neoplasm
Locally Advanced Malignant Solid Neoplasm
Metastatic Malignant Solid Neoplasm

Interventions: Biological: Pembrolizumab
Drug: Pevonedistat

First Posted Date: 2021-03-16

Last Posted Date: 2022-12-27

Lead Sponsor: M.D. Anderson Cancer Center

Target Recruit Count: 2

Registration Number: NCT04800627

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

Treatment of MDS/AML Patients With an Impending Hematological Relapse With AZA or ATA and Pevonedistat

Phase 2

Completed

Conditions: Acute Myeloid Leukemia in Remission
Myelodysplastic Syndromes
Minimal Residual Disease

Interventions: Drug: Pevonedistat
Drug: Azacitidine

First Posted Date: 2021-01-19

Last Posted Date: 2023-08-21

Lead Sponsor: University of Leipzig

Target Recruit Count: 14

Registration Number: NCT04712942

Locations: 🇩🇪
Universitätsklinik und Poliklinik für Innere Medizin IV, Onkologie, Hämatologie, Universitätsklinikum Halle (Saale), Halle (Saale), Germany
🇩🇪
Klinik für Innere Medizin III, Hämatologie, Onkologie, Stammzelltransplantation, Klinikum Chemnitz gGmbH, Chemnitz, Germany
🇩🇪
Medizinischen Klinik und Poliklinik I / Hämatologie, Universitätsklinikum Carl Gustav Carus an der Technischen Universität Dresden, Dresden, Germany

and more 11 locations

Expanded Access Program With Pevonedistat (Given With Azacitidine) for Adults With Higher-risk Myelodysplastic Syndromes

Conditions: Myelodysplastic Syndromes

First Posted Date: 2020-07-23

Last Posted Date: 2022-09-30

Lead Sponsor: Takeda

Registration Number: NCT04484363

A Study of Pevonedistat and Venetoclax Combined With Azacitidine to Treat Acute Myeloid Leukemia (AML) in Adults Unable to Receive Intensive Chemotherapy

Phase 2

Active, not recruiting

Conditions: Acute Myeloid Leukemia (AML)

Interventions: Drug: Venetoclax
Drug: Pevonedistat
Drug: Azacitidine

First Posted Date: 2020-02-12

Last Posted Date: 2024-12-17

Lead Sponsor: Takeda

Target Recruit Count: 164

Registration Number: NCT04266795

Locations: 🇺🇸
Houston Methodist Cancer Center, Houston, Texas, United States
🇺🇸
UC Irvine Medical Center, Orange, California, United States
🇺🇸
University Hospitals Cleveland Medical Center, Cleveland, Ohio, United States

and more 54 locations

Testing the Combination of Pevonedistat With Chemotherapy for Bile Duct Cancer of the Liver

Phase 2

Active, not recruiting

Conditions: Stage IV Hepatocellular Carcinoma AJCC v8
Stage IV Intrahepatic Cholangiocarcinoma AJCC v8
Stage IVB Hepatocellular Carcinoma AJCC v8
Metastatic Hepatocellular Carcinoma
Stage III Hepatocellular Carcinoma AJCC v8
Unresectable Intrahepatic Cholangiocarcinoma
Stage III Intrahepatic Cholangiocarcinoma AJCC v8
Stage IIIA Hepatocellular Carcinoma AJCC v8
Unresectable Cholangiocarcinoma
Stage IIIA Intrahepatic Cholangiocarcinoma AJCC v8

Interventions: Drug: Pevonedistat
Drug: Carboplatin
Drug: Paclitaxel

First Posted Date: 2019-11-25

Last Posted Date: 2025-05-04

Lead Sponsor: National Cancer Institute (NCI)

Target Recruit Count: 40

Registration Number: NCT04175912

Locations: 🇺🇸
Katmai Oncology Group, Anchorage, Alaska, United States
🇺🇸
Providence Alaska Medical Center, Anchorage, Alaska, United States
🇺🇸
Anchorage Associates in Radiation Medicine, Anchorage, Alaska, United States

and more 419 locations

Pevonedistat, Azacitidine (or Decitabine), and Venetoclax for the Treatment of Patients With Acute Myelogenous Leukemia

Phase 1

Terminated

Conditions: Acute Myelogenous Leukemia

Interventions: Drug: Azacitidine
Drug: Venetoclax
Drug: Pevonedistat

First Posted Date: 2019-11-21

Last Posted Date: 2024-06-04

Lead Sponsor: Medical College of Wisconsin

Target Recruit Count: 16

Registration Number: NCT04172844

Locations: 🇺🇸
Mayo Clinic, Rochester, Minnesota, United States
🇺🇸
Froedtert Hospital and the Medical College of Wisconsin, Milwaukee, Wisconsin, United States

Study to Compare Azacitidine Plus Pevonedistat Versus Azacitidine in Patients With Acute Myeloid Leukemia Not Eligible for Standard Chemotherapy

Phase 3

Active, not recruiting

Conditions: Leukemia, Myeloid, Acute

Interventions: Drug: Azacitidine
Drug: Pevonedistat

First Posted Date: 2019-09-16

Last Posted Date: 2025-03-17

Lead Sponsor: PETHEMA Foundation

Target Recruit Count: 302

Registration Number: NCT04090736

Locations: 🇪🇸
Complejo Hospitalario Torrecárdenas, Almería, Spain
🇪🇸
Hospital Dr. José Molina Orosa, Arrecife, Spain
🇪🇸
Hospital San Agustin, Avilés, Spain

and more 59 locations

Testing the Combination of MLN4924 (Pevonedistat), Carboplatin, and Paclitaxel in Patients With Advanced Non-small Cell Lung Cancer (NSCLC) Who Have Previously Been Treated With Immunotherapy

Phase 2

Active, not recruiting

Conditions: Metastatic Lung Non-Squamous Non-Small Cell Carcinoma
Stage IV Lung Cancer AJCC v8
Unresectable Lung Non-Small Cell Carcinoma
Unresectable Lung Non-Squamous Non-Small Cell Carcinoma
Stage IIIB Lung Cancer AJCC v8
Stage IVB Lung Cancer AJCC v8
Metastatic Lung Non-Small Cell Squamous Carcinoma
Stage IVA Lung Cancer AJCC v8

Interventions: Drug: Carboplatin
Drug: Paclitaxel
Drug: Pevonedistat

First Posted Date: 2019-05-29

Last Posted Date: 2025-04-06

Lead Sponsor: National Cancer Institute (NCI)

Target Recruit Count: 27

Registration Number: NCT03965689

Locations: 🇺🇸
Los Angeles General Medical Center, Los Angeles, California, United States
🇺🇸
Rutgers Cancer Institute of New Jersey, New Brunswick, New Jersey, United States
🇺🇸
USC / Norris Comprehensive Cancer Center, Los Angeles, California, United States

and more 7 locations

Azacitidine, Venetoclax, and Pevonedistat in Treating Patients With Newly Diagnosed Acute Myeloid Leukemia

Phase 1

Active, not recruiting

Conditions: Acute Myeloid Leukemia
Atypical Chronic Myeloid Leukemia, BCR-ABL1 Negative
Chronic Eosinophilic Leukemia, Not Otherwise Specified
Chronic Myelomonocytic Leukemia
Chronic Neutrophilic Leukemia
Essential Thrombocythemia
Myelodysplastic Syndrome
Myelodysplastic/Myeloproliferative Neoplasm With Ring Sideroblasts and Thrombocytosis
Myelodysplastic/Myeloproliferative Neoplasm, Unclassifiable
Myeloid Neoplasm

Interventions: Drug: Azacitidine
Drug: Pevonedistat
Drug: Venetoclax

First Posted Date: 2019-03-05

Last Posted Date: 2025-03-25

Lead Sponsor: M.D. Anderson Cancer Center

Target Recruit Count: 40

Registration Number: NCT03862157

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

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