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

Clinical Trials

Abemaciclib Plus Darolutamide in Prostate Cancer That Has Spread After Initial Treatment

Phase 1

Active, not recruiting

Conditions: Prostatic Neoplasms

Interventions: Drug: Abemaciclib
Drug: Darolutamide
Drug: LHRH agonist/antagonist

First Posted Date: 2023-08-21

Last Posted Date: 2024-05-30

Lead Sponsor: Eli Lilly and Company

Target Recruit Count: 10

Registration Number: NCT05999968

Locations: 🇪🇸
Hospital General Universitario Gregorio Marañon, Madrid, Madrid, Comunidad De, Spain
🇺🇸
Highlands Oncology Group, Springdale, Arkansas, United States
🇩🇪
Studienpraxis Urologie, Nürtingen, Baden-Württemberg, Germany

and more 10 locations

A Master Protocol (LY900023) That Includes Several Clinical Trials of Drugs for Children and Young Adults With Cancer

Phase 2

Recruiting

Conditions: Adolescent
Neoplasms
Child

Interventions: Drug: Ramucirumab
Drug: Cyclophosphamide
Drug: Abemaciclib
Drug: Irinotecan
Drug: Docetaxel
Drug: Gemcitabine
Drug: Vinorelbine
Drug: Temozolomide

First Posted Date: 2023-08-21

Last Posted Date: 2025-05-21

Lead Sponsor: Eli Lilly and Company

Target Recruit Count: 105

Registration Number: NCT05999994

Locations: 🇺🇸
Childrens Hospital of Alabama, Birmingham, Alabama, United States
🇺🇸
Children's Hospital of Colorado, Denver, Colorado, United States
🇺🇸
Phoenix Children's Hospital, Phoenix, Arizona, United States

and more 63 locations

An Adjuvant Endocrine-based Therapy Study of Camizestrant (AZD9833) in ER+/HER2- Early Breast Cancer (CAMBRIA-2)

Phase 3

Recruiting

Conditions: Breast Cancer, Early Breast Cancer

Interventions: Drug: Tamoxifen
Drug: Camizestrant
Drug: Anastrozole
Drug: Abemaciclib
Drug: Letrozole
Drug: Exemestane

First Posted Date: 2023-07-19

Last Posted Date: 2025-05-21

Lead Sponsor: AstraZeneca

Target Recruit Count: 5500

Registration Number: NCT05952557

Locations: 🇬🇧
Research Site, Whitchurch, United Kingdom

Abemaciclib in Newly Diagnosed Meningioma Patients

Phase 2

Recruiting

Conditions: Meningioma

Interventions: Drug: Placebo
Drug: Abemaciclib

First Posted Date: 2023-07-11

Last Posted Date: 2025-04-09

Lead Sponsor: Nader Sanai

Target Recruit Count: 72

Registration Number: NCT05940493

Locations: 🇺🇸
St. Joseph's Hospital and Medical Center, Phoenix, Arizona, United States

Genetically-informed Therapy for ER+ Breast Cancer Post-CDK4/6 Inhibitor

Phase 2

Recruiting

Conditions: Advanced Breast Cancer

Interventions: Drug: Fulvestrant
Drug: Neratinib
Drug: Alpelisib
Drug: Everolimus
Drug: Abemaciclib

First Posted Date: 2023-07-06

Last Posted Date: 2023-10-26

Lead Sponsor: Dartmouth-Hitchcock Medical Center

Target Recruit Count: 135

Registration Number: NCT05933395

Locations: 🇺🇸
Dartmouth Hitchcock Medical Center, Lebanon, New Hampshire, United States

Efficacy and Safety of Fluzoparib Combined With Adjuvant Endocrine Therapy for HR+/HER2- SNF3-subtype Early Breast Cancer (BCTOP-L-A01)

Phase 3

Recruiting

Conditions: Breast Cancer

Interventions: Drug: Fluzoparib
Drug: Anastrozole
Drug: Letrozole
Drug: Exemestane
Drug: Tamoxifen
Drug: Toremifene
Drug: Abemaciclib
Drug: LHRH agonist

First Posted Date: 2023-06-06

Last Posted Date: 2024-02-08

Lead Sponsor: Fudan University

Target Recruit Count: 766

Registration Number: NCT05891093

Locations: 🇨🇳
Sun Yat-sen University Cancer Center, Guangdong, Guangzhou, China
🇨🇳
Shanghai Sixth People's Hospital Affiliated to Shanghai Jiaotong University, Shanghai, Shanghai, China
🇨🇳
Fujian Medical University Union Hospital, Fuzhou, Fujian, China

and more 12 locations

Abemaciclib and Letrozole in Patients with Estrogen Receptor-positive Rare Ovarian Cancer

Phase 2

Recruiting

Conditions: Adult Type Granulosa Cell Tumor
Low Grade Serous Ovarian Carcinoma

Interventions: Drug: Abemaciclib
Drug: Letrozole

First Posted Date: 2023-05-24

Last Posted Date: 2025-03-19

Lead Sponsor: Universitaire Ziekenhuizen KU Leuven

Target Recruit Count: 100

Registration Number: NCT05872204

Locations: 🇧🇪
UZ Gent, Gent, Oost-Vlaanderen, Belgium
🇧🇪
UZ Leuven, Leuven, Vlaams-Brabant, Belgium
🇧🇪
CHU de Liège, Liège, Belgium

and more 9 locations

Study of AVZO-021 in Patients With Advanced Solid Tumors

Phase 1

Recruiting

Conditions: Advanced Solid Tumor
HR+/HER2- Breast Cancer
HR+, HER2-, Advanced Breast Cancer
CCNE1 Amplification
Epithelial Ovarian Cancer
Primary Peritoneal Cancer
Fallopian Tube Cancer
Endometrial Cancer
TNBC - Triple-Negative Breast Cancer

Interventions: Drug: AVZO-021
Drug: Palbociclib
Drug: Fulvestrant
Drug: Letrozole
Drug: Ribociclib
Drug: Abemaciclib
Drug: Carboplatin
Drug: Sacituzumab Govitecan-hziy

First Posted Date: 2023-05-19

Last Posted Date: 2025-04-03

Lead Sponsor: Avenzo Therapeutics, Inc.

Target Recruit Count: 430

Registration Number: NCT05867251

Locations: 🇺🇸
Texas Oncology - DFW, Dallas, Texas, United States
🇺🇸
Yale Cancer Center, New Haven, Connecticut, United States
🇺🇸
Florida Cancer Specialists, Sarasota, Florida, United States

and more 6 locations