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 a...
- 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
- -
ALPINE: Maintenance Letrozole/Abemaciclib Vs Pembrolizumab
- Conditions
- 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
Bicalutamide and Abemaciclib in Inoperable or Metastatic Androgen Receptor-positive Triple-negative Breast Cancer
- Conditions
- Interventions
- First Posted Date
- 2024-04-15
- Last Posted Date
- 2024-12-11
- 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
A First-in-human Dose Escalation and Expansion Study to Evaluate the Safety, and Tolerability of AZD8421 Alone or in Combination in Participants With Selected Advanced or Metastatic Solid Tumors
- Conditions
- Interventions
- First Posted Date
- 2024-01-03
- Last Posted Date
- 2024-10-03
- Lead Sponsor
- AstraZeneca
- Target Recruit Count
- 204
- Registration Number
- NCT06188520
- Locations
- 🇬🇧
Research Site, Manchester, United Kingdom
Functional Imaging in Prediction of Response to Abemaciclib for Advanced Hormone Receptor-Positive, HER2-Negative Breast Cancer
- Conditions
- Locally Advanced Unresectable HER2-Negative Breast CarcinomaMetastatic HER2-Negative Breast CarcinomaAnatomic Stage IV Breast Cancer AJCC v8Anatomic Stage III Breast Cancer AJCC v8Locally Advanced Unresectable Hormone Receptor-Positive Breast CarcinomaMetastatic Hormone Receptor-Positive Breast Carcinoma
- Interventions
- Drug: AbemaciclibDrug: AnastrozoleProcedure: Biospecimen CollectionProcedure: Computed TomographyProcedure: Diagnostic ImagingDrug: ExemestaneOther: Fludeoxyglucose F-18Drug: Fluorine F 18 Fluoro Furanyl NorprogesteroneDrug: FulvestrantBiological: Gonadotropin-releasing Hormone AnalogDrug: LetrozoleProcedure: Positron Emission TomographyDrug: TamoxifenDrug: Therapeutic Estradiol
- First Posted Date
- 2023-12-21
- Last Posted Date
- 2024-08-07
- Lead Sponsor
- University of Washington
- Target Recruit Count
- 60
- Registration Number
- NCT06179303
- Locations
- 🇺🇸
Siteman Cancer Center at Washington University, Saint Louis, Missouri, United States
🇺🇸Fred Hutch/University of Washington Cancer Consortium, Seattle, Washington, United States
Abemaciclib Dose Escalation to Maintain Intensity (ADE-MI)
- Conditions
- First Posted Date
- 2023-12-13
- Last Posted Date
- 2024-10-22
- Lead Sponsor
- University of Illinois at Chicago
- Target Recruit Count
- 50
- Registration Number
- NCT06169371
- Locations
- 🇺🇸
University of Illinois, Chicago, Illinois, United States
RADIANT: Pre-op Radiation With Abemaciclib and Letrozole
- First Posted Date
- 2023-11-18
- Last Posted Date
- 2024-04-03
- Lead Sponsor
- Mridula George, MD
- Target Recruit Count
- 15
- Registration Number
- NCT06139107
- Locations
- 🇺🇸
Rutgers Cancer Institute of New Jersey, New Brunswick, New Jersey, United States
A Study to Evaluate Efficacy and Safety of Giredestrant Compared With Fulvestrant (Plus a CDK4/6 Inhibitor), in Participants With ER-Positive, HER2-Negative Advanced Breast Cancer Resistant to Adjuvant Endocrine Therapy (pionERA Breast Cancer)
- First Posted Date
- 2023-10-04
- Last Posted Date
- 2024-12-16
- Lead Sponsor
- Hoffmann-La Roche
- Target Recruit Count
- 1050
- Registration Number
- NCT06065748
- Locations
- 🇺🇸
Sutter Health Medical Center, Sacramento, California, United States
🇩🇪Sozialstiftung Bamberg, Klinikum am Bruderwald, Gynäkologie, Bamberg, Germany
🇬🇷Anticancer Hospital Ag. Savas ; 2Nd Dept. of Oncology - Internal Medicine, Athens, Greece
Evaluation of Abemaciclib and Radiation Therapy Before Surgery for the Treatment of High-Risk Adipocytic Retroperitoneal Sarcoma
- First Posted Date
- 2023-09-06
- Last Posted Date
- 2024-11-27
- Lead Sponsor
- University of Washington
- Target Recruit Count
- 18
- Registration Number
- NCT06025747
- Locations
- 🇺🇸
Fred Hutch/University of Washington Cancer Consortium, Seattle, Washington, United States
A Master Protocol (LY900023) That Includes Several Clinical Trials of Drugs for Children and Young Adults With Cancer
- First Posted Date
- 2023-08-21
- Last Posted Date
- 2024-12-06
- Lead Sponsor
- Eli Lilly and Company
- Target Recruit Count
- 105
- Registration Number
- NCT05999994
- Locations
- 🇧🇪
UCL- Saint Luc, Bruxelles, Belgium
🇫🇷Institut Curie, Paris, France
🇳🇱Prinses Maxima Centrum, Utrecht, Netherlands
TRADE: Dose Escalation Tolerability of Abemaciclib in HR+ HER2- Early Stage Breast Cancer
- Conditions
- Interventions
- First Posted Date
- 2023-08-21
- Last Posted Date
- 2024-11-07
- Lead Sponsor
- Dana-Farber Cancer Institute
- Target Recruit Count
- 90
- Registration Number
- NCT06001762
- Locations
- 🇺🇸
Stamford Hospital, Stamford, Connecticut, United States
🇺🇸Eastern Maine Medical Center (Northern Light), Brewer, Maine, United States
🇺🇸New England Cancer Specialists, Scarborough, Maine, United States
Drug Development Updates
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