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 and Cabozantinib in People With Clear Cell Renal Cell Carcinoma (ccRCC)

Phase 1

Recruiting

Conditions: Metastatic Renal Cell Carcinoma

Interventions: Drug: Abemaciclib
Drug: Cabozantinib

First Posted Date: 2025-02-19

Last Posted Date: 2025-02-19

Lead Sponsor: Memorial Sloan Kettering Cancer Center

Target Recruit Count: 43

Registration Number: NCT06835972

Locations: 🇺🇸
Johns Hopkins University (Data Collection Only), Baltimore, Maryland, United States
🇺🇸
Memorial Sloan Kettering Basking Ridge (Limited Protocol Activities), Basking Ridge, New Jersey, United States
🇺🇸
Memorial Sloan Kettering Monmouth (Limited Protocol Activities), Middletown, New Jersey, United States

and more 5 locations

Using Tumor Models to Determine Treatments

Phase 2

Not yet recruiting

Conditions: Pancreatic Ductal Carcinoma
Advanced Cancer
Epithelial Tumor

Interventions: Drug: Cobimetinib
Drug: Ponatinib
Drug: Brigatinib
Drug: Colchicine
Drug: Selinexor
Drug: Abemaciclib
Drug: Neratinib
Drug: Doxorubicin
Drug: Etoposide
Drug: Ceritinib

First Posted Date: 2025-02-06

Last Posted Date: 2025-02-18

Lead Sponsor: University Health Network, Toronto

Target Recruit Count: 25

Registration Number: NCT06813079

Locations: 🇨🇦
Princess Margaret Cancer Centre, Toronto, Ontario, Canada

Safety and Tolerability of TNG456 Alone and in Combination With Abemaciclib in Patients With Solid Tumors With MTAP Loss

Phase 1

Recruiting

Conditions: Non Small Cell Lung Cancer
Glioma Glioblastoma Multiforme
Glioma, Malignant
Solid Tumor
Non-Small Cell Adenocarcinoma
Lung Cancer
Brain Tumor

Interventions: Drug: TNG456
Drug: abemaciclib

First Posted Date: 2025-02-05

Last Posted Date: 2025-04-18

Lead Sponsor: Tango Therapeutics, Inc.

Target Recruit Count: 191

Registration Number: NCT06810544

Locations: 🇺🇸
NYU Langone Health, New York, New York, United States
🇺🇸
NEXT Virginia, Fairfax, Virginia, United States

Predicting clinicAL outcoMes During First-line CDK4/6 Inhibitors Plus Endocrine Therapy in Patients With Advanced Hormone REceptor-poSitive HER2-negative Breast Cancer: the Retrospective-prospective Multicenter Italian PALMARES-2 Study

Recruiting

Conditions: Breast Tumors
HR+ HER2- Men, Pre/Postmenopausal Advanced Breast Cancer
HR+ Advanced or Metastatic Breast Cancer
HR+/HER2- Breast Cancer
HRpos Breast Neoplasms
HR-positive, HER2-negative Advanced Breast Cancer
HR-positive, HER2-negative and PIK3CA Mutation Advanced Breast Cancer
HR-positive Breast Cancer
Hormone Receptor-Positive Breast Cancer
Hormone Receptor Positive Breast Adenocarcinoma

First Posted Date: 2025-02-03

Last Posted Date: 2025-02-03

Lead Sponsor: Fondazione IRCCS Istituto Nazionale dei Tumori, Milano

Target Recruit Count: 3500

Registration Number: NCT06805812

Locations: 🇮🇹
ASST Lariana - Ospedale Sant'Anna, Como, Italy
🇮🇹
ASST Ospedale Maggiore, Cremona, Italy
🇮🇹
Azienda Ospedaliero Universitaria Careggi, Firenze, Italy

and more 21 locations

Study of PF-07220060 With Letrozole in Adults With HR-positive HER2-negative Breast Cancer Who Have Not Received Anticancer Treatment for Advanced/Metastatic Disease

Phase 3

Recruiting

Conditions: Breast Cancer

Interventions: Drug: PF-07220060
Drug: letrozole
Drug: abemaciclib
Drug: palbociclib
Drug: ribociclib

First Posted Date: 2025-01-07

Last Posted Date: 2025-05-21

Lead Sponsor: Pfizer

Target Recruit Count: 1020

Registration Number: NCT06760637

Locations: 🇧🇬
Complex Oncology Center - Shumen, Shumen, Bulgaria
🇺🇸
Ironwood Cancer & Research Centers, Scottsdale, Arizona, United States
🇺🇸
Highlands Oncology, Rogers, Arkansas, United States

and more 149 locations

A Study of Abemaciclib and Radiation Therapy in People With Metastatic Breast Cancer

Phase 1

Recruiting

Conditions: Metastatic Breast Cancer
Stage IV Breast Cancer
Breast Cancer
Breast Cancer Stage IV
Breast Cancer Metastatic
HER2-negative Breast Cancer
HER2 Negative Breast Carcinoma
Hormone-receptor-positive Breast Cancer

Interventions: Drug: Abemaciclib

First Posted Date: 2024-11-07

Last Posted Date: 2024-11-21

Lead Sponsor: Memorial Sloan Kettering Cancer Center

Target Recruit Count: 28

Registration Number: NCT06678269

Locations: 🇺🇸
Memorial Sloan Kettering at Basking Ridge (All protocol activities), Basking Ridge, New Jersey, United States
🇺🇸
Memorial Sloan Kettering Monmouth (All Protocol Activities), Middletown, New Jersey, United States
🇺🇸
Memorial Sloan Kettering Bergen (All Protocol Activities), Montvale, New Jersey, United States

and more 4 locations

Testing the Addition of an Anti-Cancer Drug, Abemaciclib, to the Usual Chemotherapy Treatment (5-Fluorouracil) for Metastatic, Refractory Colorectal Cancer

Phase 1

Recruiting

Conditions: Metastatic Microsatellite Stable Colorectal Carcinoma
Refractory Microsatellite Stable Colorectal Carcinoma
Stage IV Colorectal Cancer AJCC v8

Interventions: Drug: Abemaciclib
Procedure: Biopsy Procedure
Procedure: Biospecimen Collection
Drug: Fluorouracil
Procedure: Radiologic Imaging Procedure

First Posted Date: 2024-10-23

Last Posted Date: 2025-05-18

Lead Sponsor: National Cancer Institute (NCI)

Target Recruit Count: 39

Registration Number: NCT06654037

Locations: 🇺🇸
University of Cincinnati Cancer Center-West Chester, West Chester, Ohio, United States
🇺🇸
University of Pittsburgh Cancer Institute (UPCI), Pittsburgh, Pennsylvania, United States
🇺🇸
UCI Health - Chao Family Comprehensive Cancer Center and Ambulatory Care, Irvine, California, United States

and more 2 locations

A Precision Medicine Approach (SMMART-ACT) for the Treatment of Patients with Advanced Sarcoma, Prostate, Breast, Ovarian or Pancreatic Cancer

Phase 2

Not yet recruiting

Conditions: Advanced Breast Carcinoma
Advanced Malignant Solid Neoplasm
Advanced Ovarian Carcinoma
Advanced Pancreatic Carcinoma
Advanced Prostate Carcinoma
Advanced Sarcoma
Anatomic Stage III Breast Cancer AJCC V8
Anatomic Stage IV Breast Cancer AJCC V8
Stage III Ovarian Cancer AJCC V8
Stage III Pancreatic Cancer AJCC V8

Interventions: Drug: Abemaciclib
Procedure: Biopsy
Procedure: Biospecimen Collection
Drug: Fulvestrant
Procedure: Bone Scan
Drug: Carboplatin
Drug: Olaparib
Procedure: Echocardiography
Drug: Gemcitabine
Drug: Pemetrexed
Drug: Exemestane
Drug: Letrozole
Drug: Gefitinib
Procedure: Multigated Acquisition Scan
Other: Survey Administration
Drug: Tamoxifen
Drug: Temozolomide
Drug: Paclitaxel
Drug: Osimertinib
Drug: Pegylated Liposomal Doxorubicin Hydrochloride

First Posted Date: 2024-10-08

Last Posted Date: 2025-02-13

Lead Sponsor: OHSU Knight Cancer Institute

Target Recruit Count: 30

Registration Number: NCT06630325

Locations: 🇺🇸
OHSU Knight Cancer Institute, Portland, Oregon, United States

A Randomised Trial Comparing Trastuzumab Deruxtecan to CDK4/6 Inhibitors in Non-luminal A, ER-positive/HER2-low Metastatic Breast Cancer

Phase 3

Not yet recruiting

Conditions: Metastatic Breast Cancer
ER-positive Breast Cancer
Luminal B
Her2 Enriched
Basal Like

Interventions: Drug: Ribociclib with ET
Drug: Trastuzumab deruxtecan (T-DXd)
Drug: Abemaciclib with ET

First Posted Date: 2024-09-19

Last Posted Date: 2024-10-10

Lead Sponsor: Danish Breast Cancer Cooperative Group

Target Recruit Count: 504

Registration Number: NCT06585969

ONO-4578-06:Phase I Study of ONO-4578 and Letrozole Plus CDK4 /6 Inhibitors in Breast Cancer

Phase 1

Active, not recruiting

Conditions: Metastatic Breast Cancer
Hormone Receptor-positive Breast Cancer
HER2-negative Breast Cancer
Recurrent Breast Cancer

Interventions: Drug: ONO-4578
Drug: letrozole
Drug: abemaciclib
Drug: Palbociclib

First Posted Date: 2024-08-26

Last Posted Date: 2024-08-26

Lead Sponsor: Ono Pharmaceutical Co. Ltd

Target Recruit Count: 46

Registration Number: NCT06570031

Locations: 🇯🇵
Saitama Cancer Center, Ina, Saitama, Japan
🇯🇵
Tokyo Medical University Hospital, Shinjuku-ku, Tokyo, Japan
🇯🇵
National Cancer Center Hospital East, Kashiwa-shi, Chiba, Japan

and more 10 locations

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