MedPath

Abemaciclib

Generic Name
Abemaciclib
Brand Names
Verzenio, Verzenios
Drug Type
Small Molecule
Chemical Formula
C27H32F2N8
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

Precision Treatment of HR+ HER2- Advanced Breast Cancer Based on SNF Molecular Subtyping

Phase 2
Not yet recruiting
Conditions
Breast Cancer
Interventions
First Posted Date
2024-08-19
Last Posted Date
2024-08-19
Lead Sponsor
Fudan University
Target Recruit Count
260
Registration Number
NCT06561022
Locations
🇨🇳

270 Dongan Road, Fudan University Shanghai Cancer Center, Shanghai, China

Testing the Addition of an Anti-cancer Drug, Abemaciclib, to the Usual Chemotherapy Treatment (Gemcitabine) for Soft Tissue Sarcoma

Phase 1
Suspended
Conditions
Advanced Dedifferentiated Liposarcoma
Advanced Leiomyosarcoma
Advanced Soft Tissue Sarcoma
Metastatic Dedifferentiated Liposarcoma
Metastatic Leiomyosarcoma
Metastatic Soft Tissue Sarcoma
Stage III Soft Tissue Sarcoma of the Trunk and Extremities AJCC v8
Stage IV Soft Tissue Sarcoma of the Trunk and Extremities AJCC v8
Interventions
Procedure: Biopsy Procedure
Procedure: Biospecimen Collection
Other: Fluorothymidine F-18
Procedure: Positron Emission Tomography
First Posted Date
2024-07-12
Last Posted Date
2025-04-17
Lead Sponsor
National Cancer Institute (NCI)
Target Recruit Count
74
Registration Number
NCT06498648
Locations
🇺🇸

M D Anderson Cancer Center, Houston, Texas, United States

A Real-life Study to Understand the Use and Effects of Palbociclib in US Patients With Breast Cancer

Active, not recruiting
Conditions
Breast Cancer
Malignant Neoplasm of Breast
Interventions
First Posted Date
2024-07-10
Last Posted Date
2024-07-10
Lead Sponsor
Pfizer
Target Recruit Count
5087
Registration Number
NCT06495164
Locations
🇺🇸

Pfizer New York, New York, New York, United States

A Study Comparing Abemaciclib Plus Temozolomide to Temozolomide Monotherapy in Children and Young Adults With High-grade Glioma Following Radiotherapy

Phase 2
Recruiting
Conditions
Glioma
Interventions
First Posted Date
2024-05-14
Last Posted Date
2025-04-18
Lead Sponsor
Eli Lilly and Company
Target Recruit Count
45
Registration Number
NCT06413706
Locations
🇺🇸

UC San Diego Moores Cancer Center, La Jolla, California, United States

🇺🇸

Rhode Island Hospital/Hasbro Children's Hospital, Providence, Rhode Island, United States

🇺🇸

UT Health San Antonio, San Antonio, Texas, United States

and more 52 locations

Sequential Therapies Modeled on Evolutionary Dynamics for Breast Cancer

First Posted Date
2024-05-10
Last Posted Date
2025-05-06
Lead Sponsor
H. Lee Moffitt Cancer Center and Research Institute
Target Recruit Count
15
Registration Number
NCT06409390
Locations
🇺🇸

Moffitt Cancer Center, Tampa, Florida, United States

Saruparib (AZD5305) Plus Camizestrant Compared With CDK4/6 Inhibitor Plus Endocrine Therapy or Plus Camizestrant in HR-Positive, HER2-Negative (IHC 0, 1+, 2+/ ISH Non-amplified), BRCA1, BRCA2, or PALB2m Advanced Breast Cancer

First Posted Date
2024-04-24
Last Posted Date
2025-05-15
Lead Sponsor
AstraZeneca
Target Recruit Count
500
Registration Number
NCT06380751
Locations
🇬🇧

Research Site, Taunton, United Kingdom

Characteristics and Predictors of Liver Injury in Cyclin-dependent Kinase Inhibitors 4/6 (CDK4/6)-Treated Patients With Advanced Breast Cancer

Completed
Conditions
DILI
First Posted Date
2024-04-16
Last Posted Date
2024-04-16
Lead Sponsor
University of Milano Bicocca
Target Recruit Count
128
Registration Number
NCT06367335
Locations
🇮🇹

University of Milano-Bicocca,, Monza, Italy

ALPINE: Maintenance Letrozole/Abemaciclib Vs Pembrolizumab

Phase 2
Recruiting
Conditions
Endometrial Cancer
Recurrent Endometrial Cancer
TP53
Interventions
First Posted Date
2024-04-15
Last Posted Date
2024-10-31
Lead Sponsor
Dana-Farber Cancer Institute
Target Recruit Count
76
Registration Number
NCT06366347
Locations
🇺🇸

Beth Israel Deaconess Medical Center, Boston, Massachusetts, United States

🇺🇸

Brigham and Women's Hospital, Boston, Massachusetts, United States

🇺🇸

Dana-Farber Cancer Institute, Boston, Massachusetts, United States

and more 3 locations

Bicalutamide and Abemaciclib in Inoperable or Metastatic Androgen Receptor-positive Triple-negative Breast Cancer

Phase 2
Recruiting
Conditions
Triple Negative Breast Neoplasms
Interventions
First Posted Date
2024-04-15
Last Posted Date
2025-05-08
Lead Sponsor
Universitaire Ziekenhuizen KU Leuven
Target Recruit Count
53
Registration Number
NCT06365788
Locations
🇧🇪

Antwerp University Hospital, Antwerp, Belgium

🇧🇪

Gasthuiszusters Antwerpen, Antwerp, Belgium

🇧🇪

University Hospital Brussels, Brussel, Belgium

and more 3 locations

Chemotherapy Omission in ER+/HER2- Breast Cancer With 1-3 Positive Lymph Nodes Receiving Extended Adjuvant Abemaciclib

Phase 3
Recruiting
Conditions
Breast Cancer
Interventions
Drug: treatment of physician's choice
First Posted Date
2024-04-02
Last Posted Date
2024-04-10
Lead Sponsor
Fudan University
Target Recruit Count
1900
Registration Number
NCT06341621
Locations
🇨🇳

Zhimin Cancer Shao, Shanghai, China

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