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
Clinical Trials
Related News

A Randomized Study Comparing the Immune Modulation Effect of Ribociclib, Palbociclib, and Abemaciclib in ER+/HER2- EBC

Phase 2
Recruiting
Conditions
Breast Cancer
Hormone Receptor-positive Breast Cancer
Hormone Therapy
Interventions
First Posted Date
2023-03-13
Last Posted Date
2023-03-16
Lead Sponsor
National Taiwan University Hospital
Target Recruit Count
60
Registration Number
NCT05766410
Locations
🇨🇳

Department of Oncology, National Taiwan University Hospital, Taipei City, Taiwan

🇨🇳

Department of Oncology,National Taiwan University Hospital, Taipei, Taiwan

First-in-Human Study of RLY-5836 in Advanced Breast Cancer and Other Solid Tumors

Phase 1
Completed
Conditions
HER2-negative Breast Cancer
Breast Cancer
Unresectable Solid Tumor
PIK3CA Mutation
Solid Tumor, Adult
Hormone Receptor Positive Tumor
Metastatic Breast Cancer
Advanced Breast Cancer
Interventions
First Posted Date
2023-03-08
Last Posted Date
2025-05-16
Lead Sponsor
Relay Therapeutics, Inc.
Target Recruit Count
41
Registration Number
NCT05759949
Locations
🇺🇸

Massachusetts General Hospital, Boston, Massachusetts, United States

🇺🇸

Community Cancer Center North, Indianapolis, Indiana, United States

🇺🇸

Huntsman Cancer Institute, University of Utah, Salt Lake City, Utah, United States

and more 4 locations

Open-Label Study to Evaluate the Safety, Tolerability, PK, and Efficacy of INX-315 in Patients With Advanced Cancer

Phase 1
Recruiting
Conditions
Breast Cancer
Breast Cancer Metastatic
Hormone Receptor Positive Tumor
Human Epidermal Growth Factor 2 Negative Carcinoma of Breast
Ovarian Cancer
Advanced Cancer
CCNE1 Amplification
Solid Tumor
Metastatic Cancer
Interventions
First Posted Date
2023-02-21
Last Posted Date
2025-04-27
Lead Sponsor
Incyclix Bio
Target Recruit Count
150
Registration Number
NCT05735080
Locations
🇺🇸

Georgia Cancer Center at Augusta University, Augusta, Georgia, United States

🇺🇸

Karmanos Cancer Institute, Detroit, Michigan, United States

🇺🇸

UTSW Medical Center, Dallas, Texas, United States

and more 7 locations

A Study of Ruxolitinib in Combination With Abemaciclib for the Treatment of Myelofibrosis

Phase 1
Recruiting
Conditions
Myelofibrosis Due to and Following Polycythemia Vera
Interventions
First Posted Date
2023-02-06
Last Posted Date
2025-02-05
Lead Sponsor
Memorial Sloan Kettering Cancer Center
Target Recruit Count
18
Registration Number
NCT05714072
Locations
🇺🇸

Memorial Sloan Kettering Basking Ridge, Basking Ridge, New Jersey, United States

🇺🇸

Memorial Sloan Kettering Monmouth, Middletown, New Jersey, United States

🇺🇸

Memorial Sloan Kettering Bergen, Montvale, New Jersey, United States

and more 4 locations

A PoC Study to Evaluate Treatments' Efficacy by Monitoring MRD Using ctDNA in HR-positive/HER2-negative EBC Population

Phase 2
Active, not recruiting
Conditions
Breast Cancer
Interventions
First Posted Date
2023-02-01
Last Posted Date
2025-04-23
Lead Sponsor
MedSIR
Target Recruit Count
1260
Registration Number
NCT05708235
Locations
🇪🇸

Clínica Universidad de Navarra, Madrid, Spain

🇪🇸

Hospital Universitario Arnau de Vilanova de Lleida, Lleida, Spain

🇪🇸

Hospital Universitario de Torrejón, Madrid, Spain

and more 20 locations

Phase IV Multi-arm Study of CDK4/6 Pharmacokinetics in Healthy Volunteers With Known CYP3A4*22 Genotype

First Posted Date
2023-01-20
Last Posted Date
2024-02-02
Lead Sponsor
University of Michigan Rogel Cancer Center
Registration Number
NCT05691400

Neo-DAB: Darolutamide and Abemaciclib in Prostate Cancer

Phase 1
Active, not recruiting
Conditions
Metastatic Prostate Cancer
Non-metastatic Prostate Cancer
Prostate Cancer
Interventions
First Posted Date
2022-11-16
Last Posted Date
2024-08-20
Lead Sponsor
Praful Ravi, MB BCHir, MRCP
Target Recruit Count
9
Registration Number
NCT05617885
Locations
🇺🇸

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

VS-6766+Abema+Fulv in Met HR+/HER- BC

Phase 1
Recruiting
Conditions
Breast Cancer
Hormone Receptor Positive HER-2 Negative Breast Cancer
Hormone Receptor-positive Breast Cancer
Interventions
First Posted Date
2022-11-08
Last Posted Date
2025-02-28
Lead Sponsor
Adrienne G. Waks
Target Recruit Count
63
Registration Number
NCT05608252
Locations
🇺🇸

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

🇺🇸

Dana Farber Cancer Institite, Boston, Massachusetts, United States

🇺🇸

Massachusetts General Hospital Cancer Center, Boston, Massachusetts, United States

Open-Label Umbrella Study To Evaluate Safety And Efficacy Of Elacestrant In Various Combination In Patients With Metastatic Breast Cancer

First Posted Date
2022-10-03
Last Posted Date
2025-05-02
Lead Sponsor
Stemline Therapeutics, Inc.
Target Recruit Count
400
Registration Number
NCT05563220
Locations
🇺🇸

Dothan Hematology and Oncology, Dothan, Alabama, United States

🇺🇸

Mayo Clinic - Arizona, Phoenix, Arizona, United States

🇺🇸

Highlands Oncology Group, Springdale, Arkansas, United States

and more 112 locations

TACTIVE-U: A Study to Learn About the Study Medicine (Vepdegestrant) When Given With Other Medicines in People With Advanced or Metastatic Breast Cancer (Sub-Study A)

Phase 1
Active, not recruiting
Conditions
Breast Cancer
Interventions
First Posted Date
2022-09-21
Last Posted Date
2025-04-29
Lead Sponsor
Pfizer
Target Recruit Count
37
Registration Number
NCT05548127
Locations
🇺🇸

Stanford Women's Cancer Center, Palo Alto, California, United States

🇺🇸

UCSF Medical Center at Mission Bay, San Francisco, California, United States

🇺🇸

Moffitt Cancer Center - International Plaza, Tampa, Florida, United States

and more 27 locations
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