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 advanced or metastatic breast cancer that has progressed after unsuccessful endocrine therapy. It is either given alone in patients who has undergone endocrine therapy and chemotherapy after the metastasis of cancer, or in combination with Fulvestrant. Following oral treatment in patients with HR-positive, HER2-negative breast cancer, abemaciclib demonstrated increased progression-free survival rates and objective response rates. Abemaciclib has been used in trials studying the treatment of melanoma, lymphoma, neoplasm, solid tumor, and glioblastoma.

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

A Study of Abiraterone Acetate Plus Prednisone With or Without Abemaciclib (LY2835219) in Participants With Prostate Cancer

Phase 2

Active, not recruiting

Conditions: Prostate Cancer

Interventions: Drug: Abemaciclib
Drug: Abiraterone Acetate
Drug: Prednisone
Drug: Placebo

First Posted Date: 2018-10-16

Last Posted Date: 2024-10-18

Lead Sponsor: Eli Lilly and Company

Target Recruit Count: 350

Registration Number: NCT03706365

Locations: 🇺🇸
St. Joseph's Hospital and Medical Center, Phoenix, Arizona, United States
🇺🇸
Mayo Clinic in Arizona - Phoenix, Phoenix, Arizona, United States
🇺🇸
The University of Arizona Cancer Center - North Campus, Tucson, Arizona, United States

and more 107 locations

A Study of Abemaciclib (LY2835219) With and Without Food in Participants With Metastatic Breast Cancer

Phase 2

Completed

Conditions: Metastatic Breast Cancer

Interventions: Drug: Abemaciclib

First Posted Date: 2018-10-12

Last Posted Date: 2024-04-02

Lead Sponsor: Eli Lilly and Company

Target Recruit Count: 72

Registration Number: NCT03703466

Locations: 🇹🇷
Akdeniz University Medical Faculty, Antalya, Turkey
🇪🇸
Hospital Universitari Vall d'Hebron, Barcelona, Spain
🇹🇷
Medical Park Izmir Hospital, Izmir, Turkey

and more 12 locations

RESOLVE: Abemaciclib + Letrozole +/- Metformin or Zotatifin in Endometrial or Low-Grade Serous Ovarian Cancer

Phase 2

Active, not recruiting

Conditions: Endometrial Cancer
Ovarian Cancer

Interventions: Drug: Letrozole
Drug: Abemaciclib
Drug: LY3023414
Drug: Zotatifin
Drug: Metformin

First Posted Date: 2018-09-18

Last Posted Date: 2024-11-07

Lead Sponsor: Dana-Farber Cancer Institute

Target Recruit Count: 130

Registration Number: NCT03675893

Locations: 🇺🇸
Massachusetts General Hospital Cancer Center, Boston, Massachusetts, United States
🇺🇸
Beth Israel Deaconess Medical Center (BIDMC), Boston, Massachusetts, United States
🇺🇸
Dana Farber Cancer Institute, Boston, Massachusetts, United States

Mesothelioma Stratified Therapy (MiST) : A Multi-drug Phase II Trial in Malignant Mesothelioma

Phase 2

Active, not recruiting

Conditions: Mesothelioma, Malignant

Interventions: Drug: pembrolizumab & bemcentinib
Drug: Atezolizumab & Bevacizumab
Drug: Dostarlimab and Niraparib
Drug: Rucaparib
Drug: Abemaciclib

First Posted Date: 2018-08-31

Last Posted Date: 2023-03-14

Lead Sponsor: University of Leicester

Target Recruit Count: 186

Registration Number: NCT03654833

Locations: 🇬🇧
University Hospitals of Leicester NHS Trust, Leicester, United Kingdom

Abemaciclib + Nivolumab in Patients With Recurrent/Metastatic Head and Neck Squamous Cell Carcinoma That Progressed or Recurred Within Six Months After Platinum-based Chemotherapy

Phase 1

Terminated

Conditions: Head and Neck Squamous Cell Carcinoma

Interventions: Drug: Abemaciclib
Drug: Nivolumab
Procedure: Tumor biopsy
Procedure: Peripheral blood
Other: EORTC QLQ-30

First Posted Date: 2018-08-31

Last Posted Date: 2020-12-03

Lead Sponsor: Washington University School of Medicine

Target Recruit Count: 6

Registration Number: NCT03655444

Locations: 🇺🇸
Washington University School of Medicine, Saint Louis, Missouri, United States

Evaluating Cancer Response to Treatment With Abemaciclib and Fulvestrant in Women With Recurrent Endometrial Cancer

Phase 2

Active, not recruiting

Conditions: Adenocarcinoma of Endometrium

Interventions: Drug: Fulvestrant
Drug: Abemaciclib

First Posted Date: 2018-08-22

Last Posted Date: 2024-01-22

Lead Sponsor: Memorial Sloan Kettering Cancer Center

Target Recruit Count: 28

Registration Number: NCT03643510

Locations: 🇺🇸
Memorial Sloan Kettering Basking Ridge, Basking Ridge, New Jersey, United States
🇺🇸
Memorial Sloan Kettering Commack, Commack, New York, United States
🇺🇸
Memorial Sloan Kettering Monmouth, Middletown, New Jersey, United States

and more 4 locations

Fulvestrant Plus Abemaciclib in Women With Advanced Low Grade Serous Carcinoma

Phase 2

Active, not recruiting

Conditions: Malignant Neoplasms of Female Genital Organs

Interventions: Drug: Fulvestrant
Drug: Abemaciclib

First Posted Date: 2018-05-22

Last Posted Date: 2024-08-19

Lead Sponsor: M.D. Anderson Cancer Center

Target Recruit Count: 18

Registration Number: NCT03531645

Locations: 🇺🇸
University of Texas MD Anderson Cancer Center, Houston, Texas, United States

A Study Evaluating the Efficacy and Safety of Multiple Treatment Combinations in Patients With Metastatic or Locally Advanced Breast Cancer

First Posted Date: 2018-02-06

Last Posted Date: 2024-12-13

Lead Sponsor: Hoffmann-La Roche

Target Recruit Count: 580

Registration Number: NCT03424005

Locations: 🇺🇸
City of Hope, Duarte, California, United States
🇺🇸
University of California San Diego Medical Center; Moores Cancer Center, La Jolla, California, United States
🇺🇸
Stanford Cancer Institute, Stanford, California, United States

and more 36 locations