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
- Associated Therapies
- -
Multiorgan Metabolic Imaging Response Assessment of Abemaciclib
- Conditions
- Interventions
- First Posted Date
- 2017-11-13
- Last Posted Date
- 2024-03-15
- Lead Sponsor
- Jules Bordet Institute
- Target Recruit Count
- 85
- Registration Number
- NCT03339843
- Locations
- 🇫🇷
IUCT Oncopole - Institut Claudius Regaud, Toulouse, France
🇫🇷Centre Oscar Lambret, Lille, France
🇧🇪Universitair Ziekenhuis, Antwerpen, Belgium
Study of the CDK4/6 Inhibitor Abemaciclib in Solid Tumors Harboring Genetic Alterations in Genes Encoding D-type Cyclins or Amplification of CDK4 or CDK6
- First Posted Date
- 2017-10-16
- Last Posted Date
- 2024-02-06
- Lead Sponsor
- Dana-Farber Cancer Institute
- Target Recruit Count
- 38
- Registration Number
- NCT03310879
- Locations
- 🇺🇸
Dana Farber Cancer Institute, Boston, Massachusetts, United States
Korean Cancer Study Group: Translational bIomarker Driven UMbrella Project for Head and Neck (TRIUMPH), Esophageal Squamous Cell Carcinoma- Part 1 (HNSCC)]
- Conditions
- Interventions
- First Posted Date
- 2017-09-25
- Last Posted Date
- 2022-03-29
- Lead Sponsor
- Seoul National University Hospital
- Target Recruit Count
- 180
- Registration Number
- NCT03292250
- Locations
- 🇰🇷
Seoul National University Hospital, Seoul, Korea, Republic of
Phase 1/2 Study of Amcenestrant (SAR439859) Single Agent and in Combination With Other Anti-cancer Therapies in Postmenopausal Women With Estrogen Receptor Positive Advanced Breast Cancer
- Conditions
- Interventions
- First Posted Date
- 2017-09-15
- Last Posted Date
- 2024-12-06
- Lead Sponsor
- Sanofi
- Target Recruit Count
- 136
- Registration Number
- NCT03284957
- Locations
- 🇨🇦
Investigational Site Number : 1240003, Vancouver, British Columbia, Canada
🇨🇦Investigational Site Number : 1240002, Toronto, Ontario, Canada
🇨🇿Investigational Site Number : 2030002, Brno, Czechia
A Study of Multiple Immunotherapy-Based Treatment Combinations in Hormone Receptor (HR)-Positive Human Epidermal Growth Factor Receptor 2 (HER2)-Negative Breast Cancer
- First Posted Date
- 2017-09-12
- Last Posted Date
- 2024-10-21
- Lead Sponsor
- Hoffmann-La Roche
- Target Recruit Count
- 138
- Registration Number
- NCT03280563
- Locations
- 🇺🇸
The Ohio State University Comprehensive Cancer Center, Columbus, Ohio, United States
🇺🇸Univ of Pittsburgh Sch of Med; Magee-Womens Hospital, Pittsburgh, Pennsylvania, United States
🇺🇸Cedars-Sinai Medical Center, Los Angeles, California, United States
Abemaciclib (LY2835219) in Patients With Recurrent Primary Brain Tumors
- First Posted Date
- 2017-07-18
- Last Posted Date
- 2024-07-09
- Lead Sponsor
- Memorial Sloan Kettering Cancer Center
- Target Recruit Count
- 64
- Registration Number
- NCT03220646
- Locations
- 🇺🇸
Lehigh Valley Health Network, Allentown, Pennsylvania, United States
🇺🇸Hartford Healthcare Cancer Institute @ Hartford Hospital (Data collection only), Hartford, Connecticut, United States
🇺🇸Memorial Sloan Kettering Basking Ridge (All Protocol Activities), Basking Ridge, New Jersey, United States
Endocrine Therapy With or Without Abemaciclib (LY2835219) Following Surgery in Participants With Breast Cancer
- Conditions
- Interventions
- First Posted Date
- 2017-05-16
- Last Posted Date
- 2024-12-13
- Lead Sponsor
- Eli Lilly and Company
- Target Recruit Count
- 5637
- Registration Number
- NCT03155997
- Locations
- 🇺🇸
Millennium Oncology - Hollywood, Hollywood, Florida, United States
🇺🇸Renown Regional Medical Center, Reno, Nevada, United States
🇺🇸The Valley Hospital, Inc., Paramus, New Jersey, United States
Abemaciclib for Patients With Retinoblastoma-Positive, Triple Negative Metastatic Breast Cancer
- First Posted Date
- 2017-04-26
- Last Posted Date
- 2024-11-06
- Lead Sponsor
- Dana-Farber Cancer Institute
- Target Recruit Count
- 27
- Registration Number
- NCT03130439
- Locations
- 🇺🇸
Dana-Farber Cancer Institute, Boston, Massachusetts, United States
This Study in Patients With Different Types of Cancer (Solid Tumours) Aims to Find a Safe Dose of Xentuzumab in Combination With Abemaciclib With or Without Hormonal Therapies. The Study Also Tests How Effective These Medicines Are in Patients With Lung and Breast Cancer
- Conditions
- Interventions
- First Posted Date
- 2017-04-04
- Last Posted Date
- 2024-06-27
- Lead Sponsor
- Boehringer Ingelheim
- Target Recruit Count
- 133
- Registration Number
- NCT03099174
- Locations
- 🇺🇸
University of California Los Angeles, Santa Monica, California, United States
🇺🇸University of Miami, Miami, Florida, United States
🇺🇸University of Minnesota, Minneapolis, Minnesota, United States
A Study of Abemaciclib (LY2835219) Alone or in Combination With Other Agents in Participants With Previously Treated Pancreatic Ductal Adenocarcinoma
- Conditions
- Interventions
- First Posted Date
- 2016-12-05
- Last Posted Date
- 2019-11-20
- Lead Sponsor
- Eli Lilly and Company
- Target Recruit Count
- 106
- Registration Number
- NCT02981342
- Locations
- 🇺🇸
Illinois CancerCare, Peoria, Illinois, United States
🇺🇸University of Pittsburgh Medical Center, Pittsburgh, Pennsylvania, United States
🇺🇸Sarah Cannon Cancer Center, Nashville, Tennessee, United States
Drug Development Updates
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