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 in Recurrent Glioblastoma
- First Posted Date
- 2016-12-05
- Last Posted Date
- 2024-07-16
- Lead Sponsor
- Dana-Farber Cancer Institute
- Target Recruit Count
- 45
- Registration Number
- NCT02981940
- Locations
- 🇺🇸
Massachusetts General Hospital, Boston, Massachusetts, United States
🇺🇸Memorial Sloan-Kettering Cancer Center, New York, New York, United States
🇺🇸University of California, San Francisco, San Francisco, California, United States
The Drug Rediscovery Protocol (DRUP Trial)
- Conditions
- Interventions
- Drug: PanitumumabDrug: OlaparibDrug: CrizotinibDrug: ErlotinibDrug: AlectinibDrug: Ipilimumab and nivolumabDrug: SunitinibDrug: Trastuzumab and Pertuzumab (combination treatment)Drug: Vemurafenib and Cobimetinib (combination treatment)Drug: NivolumabDrug: Dabrafenib and trametinibDrug: SelpercatinibDrug: TepotinibDrug: AbemaciclibDrug: ErdafitinibDrug: Atezolizumab and BevacizumabDrug: DacomitinibDrug: DabrafenibDrug: NilotinibDrug: TrametinibDrug: VismodegibDrug: RegorafenibDrug: AfatinibDrug: RibociclibDrug: LenvatinibDrug: PembrolizumabDrug: DurvalumabDrug: RucaparibDrug: AxitinibDrug: PalbociclibDrug: CabozantinibDrug: EntrectinibDrug: TalazoparibDrug: LorlatinibDrug: AlpelisibDrug: NiraparibDrug: Pemigatinib
- First Posted Date
- 2016-10-05
- Last Posted Date
- 2024-01-24
- Lead Sponsor
- The Netherlands Cancer Institute
- Target Recruit Count
- 1550
- Registration Number
- NCT02925234
- Locations
- 🇳🇱
Meander medisch centrum, Amersfoort, Netherlands
🇳🇱Netherlands Cancer Institute, Amsterdam, Netherlands
🇳🇱Amsterdam UMC, locatie AMC, Amsterdam, Netherlands
A Study of Abemaciclib (LY2835219) in Native Chinese Participants With Advanced and/or Metastatic Cancers
- First Posted Date
- 2016-09-29
- Last Posted Date
- 2020-09-25
- Lead Sponsor
- Eli Lilly and Company
- Target Recruit Count
- 26
- Registration Number
- NCT02919696
- Locations
- 🇨🇳
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician., Shanghai, China
A Study of the Effect of Abemaciclib on Metformin and Iohexol in Healthy Participants
- Conditions
- Interventions
- First Posted Date
- 2016-08-30
- Last Posted Date
- 2019-01-04
- Lead Sponsor
- Eli Lilly and Company
- Target Recruit Count
- 40
- Registration Number
- NCT02884089
- Locations
- 🇺🇸
Dallas Clinical Research Unit, Dallas, Texas, United States
A Study of LY3214996 Administered Alone or in Combination With Other Agents in Participants With Advanced/Metastatic Cancer
- First Posted Date
- 2016-08-05
- Last Posted Date
- 2022-11-22
- Lead Sponsor
- Eli Lilly and Company
- Target Recruit Count
- 210
- Registration Number
- NCT02857270
- Locations
- 🇯🇵
National Cancer Center Hospital, Chuo-ku, Tokyo, Japan
🇺🇸Florida Cancer Specialists, Sarasota, Florida, United States
🇺🇸Massachusetts General Hospital, Boston, Massachusetts, United States
Study of Abemaciclib in Dedifferentiated Liposarcoma
- Conditions
- Interventions
- First Posted Date
- 2016-07-27
- Last Posted Date
- 2024-08-02
- Lead Sponsor
- Memorial Sloan Kettering Cancer Center
- Target Recruit Count
- 33
- Registration Number
- NCT02846987
- Locations
- 🇺🇸
Memorial Sloan Kettering Cancer Center, New York, New York, United States
Randomized Short-term Pre-surgical Study to Assess the Effects of Abemaciclib (LY2835219) in Early Breast Cancer Patients
- First Posted Date
- 2016-07-13
- Last Posted Date
- 2018-03-29
- Lead Sponsor
- Gustave Roussy, Cancer Campus, Grand Paris
- Target Recruit Count
- 101
- Registration Number
- NCT02831530
- Locations
- 🇫🇷
Gustave Roussy, Villejuif, Val De Marne, France
Expanded Access Program to Provide Abemaciclib (LY2835219) for the Treatment of Metastatic Breast Cancer
- Conditions
- First Posted Date
- 2016-06-07
- Last Posted Date
- 2017-10-31
- Lead Sponsor
- Eli Lilly and Company
- Registration Number
- NCT02792725
- Locations
- 🇺🇸
UCLA Medical Center, Santa Monica, California, United States
🇺🇸Rush University Medical Center, Chicago, Illinois, United States
🇺🇸Pacific Cancer Care, Monterey, California, United States
A Study of Anti-PD-L1 Checkpoint Antibody (LY3300054) Alone and in Combination in Participants With Advanced Refractory Solid Tumors
- Conditions
- Interventions
- First Posted Date
- 2016-06-06
- Last Posted Date
- 2024-05-31
- Lead Sponsor
- Eli Lilly and Company
- Target Recruit Count
- 215
- Registration Number
- NCT02791334
- Locations
- 🇪🇸
Hospital Madrid Norte Sanchinarro, Madrid, Spain
🇨🇳National Cheng Kung University Hospital, Tainan, Taiwan
🇺🇸University of Texas MD Anderson Cancer Center, Houston, Texas, United States
A Study of LY3039478 in Participants With Advanced or Metastatic Solid Tumors
- First Posted Date
- 2016-05-27
- Last Posted Date
- 2020-08-17
- Lead Sponsor
- Eli Lilly and Company
- Target Recruit Count
- 94
- Registration Number
- NCT02784795
- Locations
- 🇺🇸
University of Texas MD Anderson Cancer Center, Houston, Texas, United States
🇺🇸Sylvester Comprehensive Cancer Center, Miami, Florida, United States
🇺🇸Karmanos Cancer Institute, Detroit, Michigan, United States
Drug Development Updates
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