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 Participants With Non-Small Cell Lung Cancer or Breast Cancer

Phase 1

Active, not recruiting

Conditions: Non Small Cell Lung Cancer
Breast Cancer

Interventions: Drug: Abemaciclib
Drug: Pembrolizumab
Drug: Anastrozole

First Posted Date: 2016-05-20

Last Posted Date: 2024-03-25

Lead Sponsor: Eli Lilly and Company

Target Recruit Count: 100

Registration Number: NCT02779751

Locations: 🇫🇷
Hôpital Arnaud de Villeneuve - CHU Montpellier, Montpellier, Hérault, France
🇺🇸
Dana Farber Cancer Institute, Boston, Massachusetts, United States
🇺🇸
University of Colorado School of Medicine, Aurora, Colorado, United States

and more 20 locations

A Study of Abemaciclib (LY2835219) in Participants With Breast Cancer

Phase 3

Active, not recruiting

Conditions: Breast Cancer

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

First Posted Date: 2016-05-05

Last Posted Date: 2024-12-09

Lead Sponsor: Eli Lilly and Company

Target Recruit Count: 463

Registration Number: NCT02763566

Locations: 🇧🇷
Fundação Pio XII - Hospital de Câncer de Barretos, Barretos, Sao Paulo, Brazil
🇨🇳
Jilin Province Tumor Hospital, Chang Chun, Ji Lin, China
🇨🇳
Liaoning Cancer Hospital&Institute, Shenyang, Liaoning, China

and more 42 locations

A Study of Abemaciclib (LY2835219) Plus Tamoxifen or Abemaciclib Alone in Women With Metastatic Breast Cancer

Phase 2

Active, not recruiting

Conditions: Metastatic Breast Cancer

Interventions: Drug: Abemaciclib
Drug: Prophylactic Loperamide
Drug: Tamoxifen

First Posted Date: 2016-04-21

Last Posted Date: 2024-06-21

Lead Sponsor: Eli Lilly and Company

Target Recruit Count: 234

Registration Number: NCT02747004

Locations: 🇺🇸
The University of Arizona Cancer Center, Tucson, Arizona, United States
🇺🇸
The Center for Cancer and Blood Disorders, Fort Worth, Texas, United States
🇦🇷
Clinica Viedma, Viedma, Río Negro, Argentina

and more 56 locations

A Study in Advanced Cancers Using Ramucirumab (LY3009806) and Other Targeted Agents

Phase 1

Completed

Conditions: Advanced Cancer
Colorectal Cancer
Mantle Cell Lymphoma

Interventions: Drug: Ramucirumab
Drug: Merestinib
Drug: Abemaciclib

First Posted Date: 2016-04-20

Last Posted Date: 2019-03-05

Lead Sponsor: Eli Lilly and Company

Target Recruit Count: 23

Registration Number: NCT02745769

Locations: 🇺🇸
University of Texas MD Anderson Cancer Center, Houston, Texas, United States
🇺🇸
UAB Comprehensive Cancer Center, Birmingham, Alabama, 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., London, United Kingdom

TAPUR: Testing the Use of Food and Drug Administration (FDA) Approved Drugs That Target a Specific Abnormality in a Tumor Gene in People With Advanced Stage Cancer

First Posted Date: 2016-02-26

Last Posted Date: 2024-11-11

Lead Sponsor: American Society of Clinical Oncology

Target Recruit Count: 3791

Registration Number: NCT02693535

Locations: 🇺🇸
University of Alabama at Birmingham Comprehensive Cancer Center, Birmingham, Alabama, United States
🇺🇸
Cancer Treatment Centers of America-Phoenix, Phoenix, Arizona, United States
🇺🇸
Sutter Auburn, Auburn, California, United States

and more 125 locations

A Study of Abemaciclib in Participants With Cancer That is Advanced or Has Spread to Another Part(s) of the Body

Phase 1

Completed

Conditions: Neoplasm Metastasis

Interventions: Drug: Drug Cocktail
Drug: Abemaciclib

First Posted Date: 2016-02-23

Last Posted Date: 2022-10-18

Lead Sponsor: Eli Lilly and Company

Target Recruit Count: 48

Registration Number: NCT02688088

Locations: 🇺🇸
University of Kansas Hospital, Fairway, Kansas, United States
🇺🇸
South Texas Accelerated Research Therapeutics, LCC, San Antonio, Texas, United States
🇺🇸
Sarah Cannon Research Institute at HealthOne, Denver, Colorado, United States

and more 2 locations

A Study of Abemaciclib in Healthy Participants

Phase 1

Completed

Conditions: Healthy

Interventions: Drug: Loperamide
Drug: Placebo
Drug: Abemaciclib

First Posted Date: 2016-02-09

Last Posted Date: 2019-01-04

Lead Sponsor: Eli Lilly and Company

Target Recruit Count: 35

Registration Number: NCT02677844

Locations: 🇺🇸
Covance Clinical Research Unit, Evansville, Indiana, United States

A Study of Abemaciclib (LY2835219) in Women With HR+, HER2+ Locally Advanced or Metastatic Breast Cancer

Phase 2

Completed

Conditions: HER-2 Positive Breast Cancer
Hormone Receptor Positive Breast Cancer

Interventions: Drug: Abemaciclib
Drug: Standard of Care Single Agent Chemotherapy
Drug: Trastuzumab
Drug: Fulvestrant

First Posted Date: 2016-02-05

Last Posted Date: 2024-11-26

Lead Sponsor: Eli Lilly and Company

Target Recruit Count: 237

Registration Number: NCT02675231

Locations: 🇺🇸
Dana Farber Cancer Institute, Boston, Massachusetts, United States
🇺🇸
Northwest Medical Specialties, PLLC, Puyallup, Washington, United States
🇺🇸
Comprehensive Blood and Cancer Center, Bakersfield, California, United States

and more 31 locations

Abemaciclib in Children With DIPG or Recurrent/Refractory Solid Tumors

Phase 1

Completed

Conditions: Diffuse Intrinsic Pontine Glioma
Brain Tumor, Recurrent
Solid Tumor, Recurrent
Neuroblastoma, Recurrent, Refractory
Ewing Sarcoma, Recurrent, Refractory
Rhabdomyosarcoma, Recurrent, Refractory
Osteosarcoma, Recurrent, Refractory
Rhabdoid Tumor, Recurrent, Refractory

Interventions: Drug: Abemaciclib

First Posted Date: 2015-12-31

Last Posted Date: 2023-10-26

Lead Sponsor: Emory University

Target Recruit Count: 53

Registration Number: NCT02644460

Locations: 🇺🇸
Children's Healthcare of Atlanta, Egleston, Atlanta, Georgia, United States
🇺🇸
Children's Healthcare of Atlanta, Scottish Rite, Atlanta, Georgia, United States
🇺🇸
Children's Hospital Colorado, Aurora, Colorado, United States

and more 1 locations

Vismodegib, FAK Inhibitor GSK2256098, Capivasertib, and Abemaciclib in Treating Patients With Progressive Meningiomas

Phase 2

Recruiting

Conditions: Intracranial Meningioma
Recurrent Meningioma
NF2 Gene Mutation

Interventions: Drug: Abemaciclib
Drug: FAK Inhibitor GSK2256098
Drug: Capivasertib
Drug: Vismodegib

First Posted Date: 2015-08-14

Last Posted Date: 2024-10-28

Lead Sponsor: Alliance for Clinical Trials in Oncology

Target Recruit Count: 124

Registration Number: NCT02523014

Locations: 🇺🇸
Henry Ford Health Saint John Hospital, Detroit, Michigan, United States
🇺🇸
Henry Ford Saint John Hospital - Academic, Grosse Pointe Woods, Michigan, United States
🇺🇸
Henry Ford Saint John Hospital - Breast, Grosse Pointe Woods, Michigan, United States

and more 746 locations

Drug Development Updates

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