Abemaciclib

Generic Name: Abemaciclib

Brand Names: Verzenio, Verzenios

Drug Type: Small Molecule

Chemical Formula: C_₂₇H_₃₂F_₂N_₈

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: -

Clinical Trials

A Study of Abemaciclib (LY2835219) in Healthy Participants With and Without Food

Phase 1

Completed

Conditions: Healthy

Interventions: Drug: Abemaciclib

First Posted Date: 2015-06-26

Last Posted Date: 2019-01-04

Lead Sponsor: Eli Lilly and Company

Target Recruit Count: 30

Registration Number: NCT02482935

Locations: 🇺🇸
Covance Clinical Research Unit, Dallas, Texas, United States

A Study of Abemaciclib (LY2835219) in Participants With Stage IV Squamous Non-small Cell Lung Cancer

Phase 2

Completed

Conditions: Non-Small Cell Lung Cancer Stage IV

Interventions: Drug: Abemaciclib
Drug: Docetaxel

First Posted Date: 2015-05-21

Last Posted Date: 2021-08-13

Lead Sponsor: Eli Lilly and Company

Target Recruit Count: 159

Registration Number: NCT02450539

Locations: 🇺🇸
Vista Oncology Inc. PS, Olympia, Washington, 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, Seoul, Korea, Republic of
🇷🇺
Volgograd regional clinical oncology dispensary, Volzhsky, Russian Federation

and more 6 locations

A Neoadjuvant Study of Abemaciclib (LY2835219) in Postmenopausal Women With Hormone Receptor Positive, HER2 Negative Breast Cancer

Phase 2

Completed

Conditions: Breast Cancer
Early-Stage Breast Carcinoma
Hormone Receptor Positive Tumor

Interventions: Drug: Abemaciclib
Drug: Loperamide
Drug: Anastrozole

First Posted Date: 2015-05-12

Last Posted Date: 2020-06-17

Lead Sponsor: Eli Lilly and Company

Target Recruit Count: 224

Registration Number: NCT02441946

Locations: 🇺🇸
Millennium Oncology, Houston, 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, 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST) or speak with your personal physician., Taipei, Taiwan
🇺🇸
Holy Cross Hospital Inc., Fort Lauderdale, Florida, United States

and more 28 locations

A Study of Necitumumab and Abemaciclib in Participants With Non-Small Cell Lung Cancer (NSCLC)

Phase 1

Completed

Conditions: Carcinoma, Non-Small-Cell Lung
Neoplasm Metastasis

Interventions: Drug: Necitumumab
Drug: Abemaciclib

First Posted Date: 2015-04-08

Last Posted Date: 2020-07-09

Lead Sponsor: Eli Lilly and Company

Target Recruit Count: 66

Registration Number: NCT02411591

Locations: 🇪🇸
Hospital Universitario Ramon y Cajal, Madrid, Spain
🇫🇷
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., Villejuif, France
🇪🇸
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., Sevilla, Spain

A Study of Abemaciclib in Participants With Varying Degrees of Liver Impairment

Phase 1

Completed

Conditions: Hepatic Insufficiency

Interventions: Drug: Abemaciclib

First Posted Date: 2015-03-13

Last Posted Date: 2019-03-05

Lead Sponsor: Eli Lilly and Company

Target Recruit Count: 35

Registration Number: NCT02387814

Locations: 🇺🇸
DaVita Clinical Research, Minneapolis, Minnesota, United States
🇺🇸
Orlando Clinical Research Center (OCRC), Orlando, Florida, United States
🇺🇸
Clinical Pharmacology of Miami (CPMI), Miami, Florida, United States

and more 1 locations

A Study of Abemaciclib (LY2835219) in Participants With Breast Cancer, Non-small Cell Lung Cancer, or Melanoma That Has Spread to the Brain

Phase 2

Completed

Conditions: Breast Cancer
Melanoma
Brain Metastases
Non-small Cell Lung Cancer

Interventions: Drug: Abemaciclib

First Posted Date: 2014-12-04

Last Posted Date: 2020-12-19

Lead Sponsor: Eli Lilly and Company

Target Recruit Count: 162

Registration Number: NCT02308020

Locations: 🇺🇸
University of California - San Diego, La Jolla, California, United States
🇺🇸
John Wayne Cancer Institute, Santa Monica, California, United States
🇺🇸
Georgetown University Medical Center, Washington, District of Columbia, United States

and more 20 locations

A Study of Nonsteroidal Aromatase Inhibitors Plus Abemaciclib (LY2835219) in Postmenopausal Women With Breast Cancer

Phase 3

Active, not recruiting

Conditions: Breast Cancer

Interventions: Drug: Abemaciclib
Drug: Anastrozole
Drug: Placebo
Drug: Letrozole

First Posted Date: 2014-09-23

Last Posted Date: 2024-10-07

Lead Sponsor: Eli Lilly and Company

Target Recruit Count: 493

Registration Number: NCT02246621

Locations: 🇦🇹
Universitaetsklinikum Allgemeines Krankenhaus Wien, Vienna, Wien, Austria
🇯🇵
Shizuoka Cancer Center, Nagaizumi, Shizuoka, Japan
🇺🇸
Ironwood Cancer & Research Centers, Chandler, Arizona, United States

and more 131 locations

A Study of Abemaciclib (LY2835219) in Participants With Previously Treated KRAS Mutated Lung Cancer

Phase 3

Active, not recruiting

Conditions: Non Small Cell Lung Cancer

Interventions: Drug: Erlotinib
Drug: Abemaciclib

First Posted Date: 2014-06-02

Last Posted Date: 2024-10-21

Lead Sponsor: Eli Lilly and Company

Target Recruit Count: 453

Registration Number: NCT02152631

Locations: 🇺🇸
St Joseph Cancer Center, Englewood, Colorado, United States
🇧🇷
Hospital Bruno Born, Lajeados, Brazil
🇺🇸
Indiana University School of Medicine, Indianapolis, Indiana, United States

and more 69 locations

A Study of LY2835219 in Participants With Cancer

Phase 1

Completed

Conditions: Neoplasm
Neoplasm Metastasis

Interventions: Drug: Abemaciclib
Drug: Clarithromycin

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: Drug: Abemaciclib
Drug: Fulvestrant
Drug: Placebo

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

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