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 LY3499446 in Participants With Advanced Solid Tumors With KRAS G12C Mutation

Phase 1

Terminated

Conditions: Advanced Solid Tumor
Colorectal Cancer
Non-Small Cell Lung Cancer

Interventions: Drug: LY3499446
Drug: Docetaxel
Drug: Abemaciclib
Drug: Cetuximab
Drug: Erlotinib

First Posted Date: 2019-11-15

Last Posted Date: 2021-11-24

Lead Sponsor: Eli Lilly and Company

Target Recruit Count: 5

Registration Number: NCT04165031

Locations: 🇦🇺
Linear Clinical Research Ltd, Nedlands, Western Australia, Australia
🇺🇸
Memorial Sloan Kettering Cancer Center, New York, New York, United States
🇺🇸
Indiana Univ Melvin & Bren Simon Cancer Center, Indianapolis, Indiana, United States

and more 1 locations

Endocrine Therapy With Abemaciclib or Chemotherapy as Initial Metastatic Treatment in ER+/HER2- Breast Cancer

Phase 3

Recruiting

Conditions: Cancer Metastatic

Interventions: Drug: Letrozole 2.5mg
Drug: Paclitaxel injection
Drug: Anastrozole 1mg
Drug: Capecitabine tablets
Drug: Fulvestrant Prefilled Syringe
Drug: Abemaciclib

First Posted Date: 2019-11-08

Last Posted Date: 2024-01-22

Lead Sponsor: UNICANCER

Target Recruit Count: 180

Registration Number: NCT04158362

Locations: 🇫🇷
Centre Hospitalier Lyon Sud, Pierre Benite, France
🇫🇷
Centre Eugène Marquis, Rennes, France

Abemaciclib + Pembrolizumab In Glioblastoma

Phase 2

Withdrawn

Conditions: Glioblastoma

Interventions: Drug: Pembrolizumab
Drug: Abemaciclib

First Posted Date: 2019-10-07

Last Posted Date: 2021-12-14

Lead Sponsor: Dana-Farber Cancer Institute

Registration Number: NCT04118036

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

Study of eFT226 in Subjects With Selected Advanced Solid Tumor Malignancies

Phase 1

Recruiting

Conditions: Solid Tumor, Adult

Interventions: Drug: eFT226
Drug: Sotorasib
Drug: Fulvestrant
Drug: Trastuzumab
Drug: Abemaciclib

First Posted Date: 2019-09-17

Last Posted Date: 2024-05-21

Lead Sponsor: Effector Therapeutics

Target Recruit Count: 30

Registration Number: NCT04092673

Locations: 🇺🇸
Memorial Sloan Kettering Cancer Center- Westchester, Harrison, New York, United States
🇺🇸
Stanford University, Palo Alto, California, United States
🇺🇸
START Midwest, Grand Rapids, Michigan, United States

and more 11 locations

Abemaciclib w/Bevacizumab in Recurrent GBM Pts w/Loss of CDKN2A/B or Gain or Amplification of CDK4/6

Early Phase 1

Active, not recruiting

Conditions: GBM
Brain Tumor
Brain Tumor, Recurrent
Glioblastoma

Interventions: Drug: Abemaciclib
Drug: Bevacizumab

First Posted Date: 2019-08-30

Last Posted Date: 2024-04-22

Lead Sponsor: University of Texas Southwestern Medical Center

Target Recruit Count: 10

Registration Number: NCT04074785

Locations: 🇺🇸
UT Southwestern Medical Center, Dallas, Texas, United States

A Study of Abemaciclib (LY2835219) in Combination With Other Anti-Cancer Therapies in Japanese Participants With Advanced Cancer

Phase 1

Completed

Conditions: Advanced Cancer

Interventions: Drug: Abemaciclib
Drug: Abiraterone Acetate
Drug: Prednisolone

First Posted Date: 2019-08-28

Last Posted Date: 2021-09-21

Lead Sponsor: Eli Lilly and Company

Target Recruit Count: 6

Registration Number: NCT04071262

Locations: 🇯🇵
National Cancer Center Hospital East, Kashiwa, Chiba, Japan
🇯🇵
Yokohama City University Medical Center, Yokohama, Kanagawa, Japan

Abemaciclib and Letrozole in Treating Patients With Endometrial Cancer

Early Phase 1

Conditions: Endometrial Endometrioid Adenocarcinoma

Interventions: Drug: Abemaciclib
Drug: Letrozole
Procedure: Therapeutic Conventional Surgery

First Posted Date: 2019-08-08

Last Posted Date: 2021-05-03

Lead Sponsor: Northwestern University

Target Recruit Count: 27

Registration Number: NCT04049227

Locations: 🇺🇸
University of Chicago Comprehensive Cancer Center, Chicago, Illinois, United States
🇺🇸
Northwestern University, Chicago, Illinois, United States

Abemaciclib for Bone and Soft Tissue Sarcoma With Cyclin-Dependent Kinase (CDK) Pathway Alteration

Phase 2

Recruiting

Conditions: Chondrosarcoma
Osteosarcoma
Soft Tissue Sarcoma

Interventions: Drug: Abemaciclib

First Posted Date: 2019-07-31

Last Posted Date: 2024-06-20

Lead Sponsor: Medical College of Wisconsin

Target Recruit Count: 44

Registration Number: NCT04040205

Locations: 🇺🇸
Washington University in St. Louis, Saint Louis, Missouri, United States
🇺🇸
Mayo Clinic, Jacksonville, Florida, United States
🇺🇸
Froedtert Hospital & the Medical College of Wisconsin, Milwaukee, Wisconsin, United States

and more 1 locations

A Study of Abemaciclib (LY2835219) in Combination With Fulvestrant Compared to Chemotherapy in Women With HR Positive, HER2 Negative Metastatic Breast Cancer

Phase 4

Terminated

Conditions: Metastatic Breast Cancer

Interventions: Drug: Abemaciclib
Drug: Standard Chemotherapy
Drug: Fulvestrant

First Posted Date: 2019-07-24

Last Posted Date: 2021-08-24

Lead Sponsor: Eli Lilly and Company

Target Recruit Count: 4

Registration Number: NCT04031885

Locations: 🇺🇸
Yuma Regional Cancer Center, Yuma, Arizona, United States
🇺🇸
Comprehensive Blood and Cancer Center, Bakersfield, California, United States
🇺🇸
Compassionate Cancer Care Medical Group Inc, Riverside, California, United States

and more 54 locations

A Study to Evaluate Abemaciclib in Advanced Biliary Tract Carcinoma

Phase 2

Terminated

Conditions: Biliary Tract Carcinoma

Interventions: Drug: Abemaciclib

First Posted Date: 2019-07-01

Last Posted Date: 2024-10-08

Lead Sponsor: Milton S. Hershey Medical Center

Target Recruit Count: 4

Registration Number: NCT04003896

Locations: 🇺🇸
Penn State Cancer Institute, Hershey, Pennsylvania, United States

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