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 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

Clinical Trials

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: 2025-04-22

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: 2025-04-20

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: Drug: Abemaciclib

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: Drug: Abemaciclib
Drug: LY3023414
Drug: Pemetrexed
Drug: Gemcitabine
Drug: Ramucirumab
Drug: Pembrolizumab

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

A Study of LY2835219 in Healthy Participants

Phase 1

Completed

Conditions: Healthy Volunteers

Interventions: Drug: LY2835219

First Posted Date: 2014-02-11

Last Posted Date: 2019-01-07

Lead Sponsor: Eli Lilly and Company

Target Recruit Count: 24

Registration Number: NCT02059148

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., Dallas, Texas, United States

A Study of LY2835219 (Abemaciclib) in Combination With Therapies for Breast Cancer That Has Spread

Phase 1

Active, not recruiting

Conditions: Breast Neoplasms

Interventions: Drug: LY2835219
Drug: Trastuzumab
Drug: LY3023414
Drug: Endocrine therapy
Drug: Letrozole
Drug: Exemestane
Drug: Anastrozole
Drug: Tamoxifen
Drug: Fulvestrant
Drug: Everolimus
Drug: Pertuzumab
Drug: Loperamide

First Posted Date: 2014-02-06

Last Posted Date: 2025-04-20

Lead Sponsor: Eli Lilly and Company

Target Recruit Count: 198

Registration Number: NCT02057133

Locations: 🇺🇸
Memorial Sloan Kettering Cancer Center, New York, New York, United States
🇺🇸
Highlands Oncology Group - Duplicate 2, Rogers, Arkansas, United States
🇺🇸
Vanderbilt University Medical Center, Nashville, Tennessee, United States

and more 10 locations

A Study of LY2835219 in Japanese Participants With Advanced Cancer

Phase 1

Completed

Conditions: Lymphoma
Neoplasm Metastasis

Interventions: Drug: LY2835219

First Posted Date: 2013-12-18

Last Posted Date: 2020-08-24

Lead Sponsor: Eli Lilly and Company

Target Recruit Count: 12

Registration Number: NCT02014129

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., Tokyo, Japan

Study of LY2835219 for Mantle Cell Lymphoma

Phase 2

Completed

Conditions: Mantle Cell Lymphoma

Interventions: Drug: Abemaciclib

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: Drug: LY3023414
Drug: Pemetrexed
Drug: Midazolam
Drug: Fulvestrant
Drug: Abemaciclib
Drug: Letrozole
Drug: Cisplatin

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

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