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
- -
A Study of Abemaciclib (LY2835219) in Participants With HR+, HER2- Advanced Breast Cancer
- Conditions
- Interventions
- First Posted Date
- 2019-06-17
- Last Posted Date
- 2019-09-06
- Lead Sponsor
- Eli Lilly and Company
- Registration Number
- NCT03988114
- Locations
- 🇺🇸
BayCare Medical Group, Clearwater, Florida, United States
🇺🇸Texas Oncology-Arlington South, Arlington, Texas, United States
🇺🇸California Cancer Associates Research and Excellence (cCARE), Fresno, California, United States
Abemaciclib in Treating Patients With Surgically Resectable, Chemotherapy Resistant, Triple Negative Breast Cancer
- Conditions
- Anatomic Stage I Breast Cancer AJCC v8Anatomic Stage II Breast Cancer AJCC v8Anatomic Stage III Breast Cancer AJCC v8Breast Ductal Carcinoma In SituBreast Fibrocystic ChangeBreast Lobular Carcinoma In SituInvasive Breast CarcinomaPrognostic Stage I Breast Cancer AJCC v8Prognostic Stage IA Breast Cancer AJCC v8Prognostic Stage IB Breast Cancer AJCC v8
- Interventions
- First Posted Date
- 2019-06-07
- Last Posted Date
- 2024-08-19
- Lead Sponsor
- Mayo Clinic
- Target Recruit Count
- 200
- Registration Number
- NCT03979508
- Locations
- 🇺🇸
Mayo Clinic in Florida, Jacksonville, Florida, United States
🇺🇸Mayo Clinic in Arizona, Scottsdale, Arizona, United States
🇺🇸Mayo Clinic in Rochester, Rochester, Minnesota, United States
Testing the Addition of Copanlisib to Usual Treatment (Fulvestrant and Abemaciclib) in Metastatic Breast Cancer
- Conditions
- Interventions
- First Posted Date
- 2019-05-07
- Last Posted Date
- 2024-12-18
- Lead Sponsor
- National Cancer Institute (NCI)
- Target Recruit Count
- 24
- Registration Number
- NCT03939897
- Locations
- 🇺🇸
Wake Forest University Health Sciences, Winston-Salem, North Carolina, United States
🇺🇸Bellevue Hospital Center, New York, New York, United States
🇺🇸UC Irvine Health/Chao Family Comprehensive Cancer Center, Orange, California, United States
A Study of Abemaciclib in Combination With Sunitinib in Metastatic Renal Cell Carcinoma
- Conditions
- Interventions
- First Posted Date
- 2019-04-05
- Last Posted Date
- 2024-06-25
- Lead Sponsor
- Brown University
- Target Recruit Count
- 3
- Registration Number
- NCT03905889
- Locations
- 🇺🇸
Rhode Island Hospital, Providence, Rhode Island, United States
Abemaciclib in Treating Patients With Advanced, Refractory, and Unresectable Digestive System Neuroendocrine Tumors
- Conditions
- Foregut Neuroendocrine TumorRefractory Digestive System Neuroendocrine NeoplasmAdvanced Digestive System Neuroendocrine NeoplasmHindgut Neuroendocrine TumorLocally Advanced Unresectable Digestive System Neuroendocrine NeoplasmDigestive System Neuroendocrine TumorMidgut Neuroendocrine TumorPancreatic Neuroendocrine TumorMetastatic Digestive System Neuroendocrine Neoplasm
- Interventions
- First Posted Date
- 2019-03-27
- Last Posted Date
- 2024-08-20
- Lead Sponsor
- University of Washington
- Target Recruit Count
- 20
- Registration Number
- NCT03891784
- Locations
- 🇺🇸
Fred Hutch/University of Washington Cancer Consortium, Seattle, Washington, United States
🇺🇸University of Colorado, Denver, Colorado, United States
Serial Measurements of Molecular and Architectural Responses to Therapy (SMMART) PRIME Trial
- Conditions
- Accelerated Phase Chronic Myelogenous Leukemia, BCR-ABL1 PositiveAnatomic Stage IV Breast Cancer AJCC v8AnemiaAnn Arbor Stage III Hodgkin LymphomaAnn Arbor Stage III Non-Hodgkin LymphomaAnn Arbor Stage IV Hodgkin LymphomaAnn Arbor Stage IV Non-Hodgkin LymphomaAtypical Chronic Myeloid Leukemia, BCR-ABL1 NegativeBlast Phase Chronic Myelogenous Leukemia, BCR-ABL1 PositiveCastration-Resistant Prostate Carcinoma
- Interventions
- Drug: AbemaciclibDrug: AbirateroneDrug: AfatinibBiological: BevacizumabDrug: BicalutamideProcedure: Biospecimen CollectionDrug: BortezomibDrug: CabazitaxelDrug: CabozantinibDrug: CapecitabineDrug: CarboplatinDrug: CelecoxibDrug: CobimetinibDrug: CopanlisibDrug: DabrafenibDrug: DacomitinibDrug: DarolutamideDrug: DasatinibDrug: DoxorubicinBiological: DurvalumabDrug: EnasidenibDrug: EntrectinibDrug: EnzalutamideDrug: ErlotinibDrug: EverolimusDrug: FluorouracilDrug: IdelalisibDrug: ImatinibBiological: IpilimumabDrug: LenvatinibDrug: LeucovorinDrug: LorlatinibDrug: LosartanDrug: Nab-paclitaxelDrug: NeratinibBiological: NivolumabDrug: OlaparibDrug: OxaliplatinDrug: PalbociclibDrug: PanobinostatBiological: PembrolizumabBiological: PertuzumabDrug: PonatinibOther: Quality-of-Life AssessmentDrug: RegorafenibDrug: RuxolitinibDrug: SirolimusDrug: SorafenibDrug: SunitinibDrug: TrametinibBiological: Trastuzumab EmtansineDrug: TretinoinDrug: VemurafenibDrug: VenetoclaxDrug: VismodegibDrug: Vorinostat
- First Posted Date
- 2019-03-18
- Last Posted Date
- 2024-03-04
- Lead Sponsor
- OHSU Knight Cancer Institute
- Target Recruit Count
- 2
- Registration Number
- NCT03878524
- Locations
- 🇺🇸
OHSU Knight Cancer Institute, Portland, Oregon, United States
Tucatinib + Abemaciclib + Herceptin for HER2+ MBC
- Conditions
- Interventions
- First Posted Date
- 2019-02-19
- Last Posted Date
- 2020-10-23
- Lead Sponsor
- Dana-Farber Cancer Institute
- Registration Number
- NCT03846583
(CLONEVO): Cell cycLe inhbitiON to Target the EVolution of UrOthelial Cancer
- First Posted Date
- 2019-02-12
- Last Posted Date
- 2024-01-17
- Lead Sponsor
- Weill Medical College of Cornell University
- Target Recruit Count
- 20
- Registration Number
- NCT03837821
- Locations
- 🇺🇸
UT Southwestern Medical Center - Simmons Comprehensive Cancer Center, Dallas, Texas, United States
🇺🇸Moffitt Cancer Center, Tampa, Florida, United States
🇺🇸Weill Cornell Medicine, New York, New York, United States
Abemaciclib and Nivolumab for Subjects With Hepatocellular Carcinoma
- First Posted Date
- 2018-12-20
- Last Posted Date
- 2022-12-14
- Lead Sponsor
- Abramson Cancer Center at Penn Medicine
- Target Recruit Count
- 7
- Registration Number
- NCT03781960
- Locations
- 🇺🇸
Abramson Cancer Center of the University of Pennsylvania, Philadelphia, Pennsylvania, United States
Named Patient Use Program to Provide Abemaciclib (LY2835219) for the Treatment of Metastatic Breast Cancer
- Conditions
- First Posted Date
- 2018-12-04
- Last Posted Date
- 2024-12-16
- Lead Sponsor
- Eli Lilly and Company
- Registration Number
- NCT03763604
- Locations
- 🇦🇺
Liverpool Hospital, Liverpool, New South Wales, Australia
🇦🇺North West Cancer Centre, North Tamworth, New South Wales, Australia
🇦🇺St Vincent's Hospital Sydney, Sydney, New South Wales, Australia
Drug Development Updates
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