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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 LY2835219 in Participants With Cancer

Phase 1
Completed
Conditions
Neoplasm
Neoplasm Metastasis
Interventions
First Posted Date
2014-04-21
Last Posted Date
2019-01-07
Lead Sponsor
Eli Lilly and Company
Target Recruit Count
26
Registration Number
NCT02117648
Locations
🇺🇸

Accelerated Comm. Oncology Research Network (ACORN), Memphis, Tennessee, United States

🇺🇸

The West Clinic, Memphis, Tennessee, United States

A Study of Abemaciclib (LY2835219) Combined With Fulvestrant in Women With Hormone Receptor Positive HER2 Negative Breast Cancer

Phase 3
Active, not recruiting
Conditions
Breast Neoplasms
Interventions
First Posted Date
2014-04-08
Last Posted Date
2024-08-01
Lead Sponsor
Eli Lilly and Company
Target Recruit Count
669
Registration Number
NCT02107703
Locations
🇲🇽

OCA Hospital, Monterrey, Nuevo León, Mexico

🇺🇸

Kaiser Permanente, Riverside, California, United States

🇺🇸

University of California - San Diego, La Jolla, California, United States

and more 136 locations

A Study of Abemaciclib (LY2835219) In Participants With Previously Treated Breast Cancer That Has Spread

Phase 2
Completed
Conditions
Metastatic Breast Cancer
Interventions
First Posted Date
2014-04-03
Last Posted Date
2020-01-21
Lead Sponsor
Eli Lilly and Company
Target Recruit Count
132
Registration Number
NCT02102490
Locations
🇺🇸

Texas Oncology-Plano West, Plano, Texas, United States

🇺🇸

Northwest Cancer Specialists PC, Vancouver, Washington, United States

🇺🇸

Univ of California San Francisco, San Francisco, California, United States

and more 24 locations

A Study of Abemaciclib (LY2835219) in Combination With Another Anti-cancer Drug in Participants With Lung Cancer (NSCLC)

Phase 1
Completed
Conditions
Carcinoma, Non-small Cell Lung
Interventions
First Posted Date
2014-03-06
Last Posted Date
2020-09-11
Lead Sponsor
Eli Lilly and Company
Target Recruit Count
142
Registration Number
NCT02079636
Locations
🇺🇸

Highlands Oncology Group, Fayetteville, Arkansas, United States

🇺🇸

Indiana Cancer Pavilion, Indianapolis, Indiana, United States

🇺🇸

The West Clinic, Germantown, Tennessee, United States

and more 7 locations

Study of LY2835219 for Mantle Cell Lymphoma

Phase 2
Completed
Conditions
Mantle Cell Lymphoma
Interventions
First Posted Date
2012-12-03
Last Posted Date
2023-09-21
Lead Sponsor
Eli Lilly and Company
Target Recruit Count
28
Registration Number
NCT01739309
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., Ulm, Germany

A Study of LY3023414 in Participants With Advanced Cancer

Phase 1
Completed
Conditions
Metastatic Breast Cancer
Non-small Cell Lung Cancer
Malignant Mesothelioma
Advanced Cancer
Metastatic Cancer
Non-Hodgkin's Lymphoma
Interventions
First Posted Date
2012-08-01
Last Posted Date
2022-04-08
Lead Sponsor
Eli Lilly and Company
Target Recruit Count
156
Registration Number
NCT01655225
Locations
🇺🇸

UCLA Medical Center, Los Angeles, California, United States

🇺🇸

Penn Presbyterian Medical Center, Philadelphia, Pennsylvania, United States

🇮🇹

Azienda Ospedaliero - Universitaria S. Luigi Gonzaga, Orbassano, Torino, Italy

and more 5 locations

A Phase 1 Study of LY2835219 In Participants With Advanced Cancer

Phase 1
Completed
Conditions
Advanced Cancer
Interventions
First Posted Date
2011-07-14
Last Posted Date
2023-03-01
Lead Sponsor
Eli Lilly and Company
Target Recruit Count
225
Registration Number
NCT01394016
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, San Antonio, Texas, United States

🇺🇸

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., Santa Monica, California, United States

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