Abemaciclib

Generic Name: Abemaciclib

Brand Names: Verzenio, Verzenios

Drug Type: Small Molecule

Chemical Formula: C_₂₇H_₃₂F_₂N_₈

CAS Number: 1231929-97-7

Unique Ingredient Identifier: 60UAB198HK

Background: Abemaciclib is an antitumor agent and dual inhibitor of cyclin-dependent kinases 4 (CDK4) and 6 (CDK6) that are involved in the cell cycle and promotion of cancer cell growth in case of unregulated activity. On September 28, 2017, FDA granted approval of abemaciclib treatment under the market name Verzenio for the treatment of HR-positive and HER2-negative a...

Indication: 适应症为:⑴单药治疗接受过内分泌疗法和化疗后疾病进展的 ER+/HER2-晚期或转移性乳腺癌；⑵或联合氟维司群，二线治疗接受过内分泌疗法后疾病进展的 ER+/HER2-晚期或转移性乳腺癌；⑶联合芳香酶抑制剂作为 ER+/HER2-绝经后女性晚期或转移性乳腺癌的初始内分泌疗法。

Associated Conditions: HR+, HER2-, Advanced Breast Cancer, Early Hormone Receptor Positive, HER2/Neu Negative Node Positive Breast Cancer, Metastatic HR + HER2 - breast cancer

Associated Therapies: -

Clinical Trials

Multiorgan Metabolic Imaging Response Assessment of Abemaciclib

Phase 2

Completed

Conditions: Esophageal Adenocarcinoma
Esophagus SCC
Cholangiocarcinoma
Urothelial/Bladder Cancer, Nos
Endometrial Cancer

Interventions: Drug: Abemaciclib

First Posted Date: 2017-11-13

Last Posted Date: 2024-03-15

Lead Sponsor: Jules Bordet Institute

Target Recruit Count: 85

Registration Number: NCT03339843

Locations: 🇫🇷
IUCT Oncopole - Institut Claudius Regaud, Toulouse, France
🇫🇷
Centre Oscar Lambret, Lille, France
🇧🇪
Universitair Ziekenhuis, Antwerpen, Belgium

and more 8 locations

Study of the CDK4/6 Inhibitor Abemaciclib in Solid Tumors Harboring Genetic Alterations in Genes Encoding D-type Cyclins or Amplification of CDK4 or CDK6

Phase 2

Recruiting

Conditions: Cancer

Interventions: Drug: Abemaciclib

First Posted Date: 2017-10-16

Last Posted Date: 2024-02-06

Lead Sponsor: Dana-Farber Cancer Institute

Target Recruit Count: 38

Registration Number: NCT03310879

Locations: 🇺🇸
Dana Farber Cancer Institute, Boston, Massachusetts, United States

Korean Cancer Study Group: Translational bIomarker Driven UMbrella Project for Head and Neck (TRIUMPH), Esophageal Squamous Cell Carcinoma- Part 1 (HNSCC)]

Phase 2

Completed

Conditions: Head and Neck Neoplasms
HNSCC

Interventions: Drug: BYL719
Drug: Durvalumab,Tremelimumab
Drug: Poziotinib
Drug: Nintedanib
Drug: Abemaciclib

First Posted Date: 2017-09-25

Last Posted Date: 2022-03-29

Lead Sponsor: Seoul National University Hospital

Target Recruit Count: 180

Registration Number: NCT03292250

Locations: 🇰🇷
Seoul National University Hospital, Seoul, Korea, Republic of

Phase 1/2 Study of Amcenestrant (SAR439859) Single Agent and in Combination With Other Anti-cancer Therapies in Postmenopausal Women With Estrogen Receptor Positive Advanced Breast Cancer

Phase 1

Terminated

Conditions: Breast Cancer

Interventions: Drug: Amcenestrant
Drug: Everolimus
Drug: Palbociclib
Drug: Alpelisib
Drug: Abemaciclib

First Posted Date: 2017-09-15

Last Posted Date: 2024-12-06

Lead Sponsor: Sanofi

Target Recruit Count: 136

Registration Number: NCT03284957

Locations: 🇨🇦
Investigational Site Number : 1240003, Vancouver, British Columbia, Canada
🇨🇦
Investigational Site Number : 1240002, Toronto, Ontario, Canada
🇨🇿
Investigational Site Number : 2030002, Brno, Czechia

and more 22 locations

A Study of Multiple Immunotherapy-Based Treatment Combinations in Hormone Receptor (HR)-Positive Human Epidermal Growth Factor Receptor 2 (HER2)-Negative Breast Cancer

Phase 1

Completed

Conditions: Breast Neoplasms

Interventions: Drug: Atezolizumab (MPDL3280A), an engineered anti-programmed death-ligand 1 (PD-L1) antibody
Drug: Ipatasertib
Drug: Entinostat
Drug: Fulvestrant
Drug: Bevacizumab
Drug: Exemestane
Drug: Abemaciclib
Drug: Tamoxifen

First Posted Date: 2017-09-12

Last Posted Date: 2024-10-21

Lead Sponsor: Hoffmann-La Roche

Target Recruit Count: 138

Registration Number: NCT03280563

Locations: 🇺🇸
The Ohio State University Comprehensive Cancer Center, Columbus, Ohio, United States
🇺🇸
Univ of Pittsburgh Sch of Med; Magee-Womens Hospital, Pittsburgh, Pennsylvania, United States
🇺🇸
Cedars-Sinai Medical Center, Los Angeles, California, United States

and more 24 locations

Abemaciclib (LY2835219) in Patients With Recurrent Primary Brain Tumors

Phase 2

Active, not recruiting

Conditions: Brain Tumor

Interventions: Drug: abemaciclib

First Posted Date: 2017-07-18

Last Posted Date: 2024-07-09

Lead Sponsor: Memorial Sloan Kettering Cancer Center

Target Recruit Count: 64

Registration Number: NCT03220646

Locations: 🇺🇸
Lehigh Valley Health Network, Allentown, Pennsylvania, United States
🇺🇸
Hartford Healthcare Cancer Institute @ Hartford Hospital (Data collection only), Hartford, Connecticut, United States
🇺🇸
Memorial Sloan Kettering Basking Ridge (All Protocol Activities), Basking Ridge, New Jersey, United States

and more 5 locations

Endocrine Therapy With or Without Abemaciclib (LY2835219) Following Surgery in Participants With Breast Cancer

Phase 3

Active, not recruiting

Conditions: Breast Cancer

Interventions: Drug: Abemaciclib
Drug: Standard Adjuvant Endocrine Therapy

First Posted Date: 2017-05-16

Last Posted Date: 2024-12-13

Lead Sponsor: Eli Lilly and Company

Target Recruit Count: 5637

Registration Number: NCT03155997

Locations: 🇺🇸
Millennium Oncology - Hollywood, Hollywood, Florida, United States
🇺🇸
Renown Regional Medical Center, Reno, Nevada, United States
🇺🇸
The Valley Hospital, Inc., Paramus, New Jersey, United States

and more 602 locations

Abemaciclib for Patients With Retinoblastoma-Positive, Triple Negative Metastatic Breast Cancer

Phase 2

Terminated

Conditions: Breast Cancer

Interventions: Drug: Abemaciclib

First Posted Date: 2017-04-26

Last Posted Date: 2024-11-06

Lead Sponsor: Dana-Farber Cancer Institute

Target Recruit Count: 27

Registration Number: NCT03130439

Locations: 🇺🇸
Dana-Farber Cancer Institute, Boston, Massachusetts, United States

This Study in Patients With Different Types of Cancer (Solid Tumours) Aims to Find a Safe Dose of Xentuzumab in Combination With Abemaciclib With or Without Hormonal Therapies. The Study Also Tests How Effective These Medicines Are in Patients With Lung and Breast Cancer

Phase 1

Completed

Conditions: Neoplasms
Breast Neoplasms

Interventions: Drug: Xentuzumab
Drug: Abemaciclib
Drug: Letrozole
Drug: Anastrozole
Drug: Fulvestrant

First Posted Date: 2017-04-04

Last Posted Date: 2024-06-27

Lead Sponsor: Boehringer Ingelheim

Target Recruit Count: 133

Registration Number: NCT03099174

Locations: 🇺🇸
University of California Los Angeles, Santa Monica, California, United States
🇺🇸
University of Miami, Miami, Florida, United States
🇺🇸
University of Minnesota, Minneapolis, Minnesota, United States

and more 27 locations

A Study of Abemaciclib (LY2835219) Alone or in Combination With Other Agents in Participants With Previously Treated Pancreatic Ductal Adenocarcinoma

Phase 2

Completed

Conditions: Pancreatic Ductal Adenocarcinoma

Interventions: Drug: Abemaciclib
Drug: Gemcitabine
Drug: LY3023414
Drug: Capecitabine

First Posted Date: 2016-12-05

Last Posted Date: 2019-11-20

Lead Sponsor: Eli Lilly and Company

Target Recruit Count: 106

Registration Number: NCT02981342

Locations: 🇺🇸
Illinois CancerCare, Peoria, Illinois, United States
🇺🇸
University of Pittsburgh Medical Center, Pittsburgh, Pennsylvania, United States
🇺🇸
Sarah Cannon Cancer Center, Nashville, Tennessee, United States

and more 10 locations

Drug Development Updates

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