Clinical trials: Abemaciclib
ER-Positive HER2-Negative Breast Cancer
Phase III Study to Assess AZD9833+ CDK4/6 Inhibitor in HR+/HER2-MBC With Detectable ESR1m Before Progression (SERENA-6)
The study is intended to show superiority of AZD9833 in combination with CDK4/6 inhibitor (palbociclib, abemaciclib or ribociclib) versus aromatase inhibitors (anastrozole or letrozole) in combination with CDK4/6 inhibitor in…
- Trial name
- SERENA-6 (NCT04964934)
- Testing
- AZD9833, Anastrozole, Letrozole
- Where
- 264 sites in United States, Australia and 21 more
- Volunteers
- 315 people
- Sponsor
- AstraZeneca
Breast Cancer, Malignant Neoplasm of Breast
A Real-life Study to Understand the Use and Effects of Palbociclib in US Patients With Breast Cancer
Palbociclib, the first oral CDK4/6 inhibitor, is an approved medicine indicated for the treatment of a kind of advanced/metastatic breast cancer (MBC), called hormone receptors positive (HR+)/ Human epidermal growth factor…
- Trial name
- NCT06495164
- Testing
- Palbociclib, Aromatase inhibitor, Ribociclib
- Where
- United States
- Volunteers
- 1 people
- Sponsor
- Pfizer
HR+/HER2- Breast Cancer
BGB-43395 Plus Letrozole Versus CDK4/6i Plus Letrozole for Patients With Advanced or Metastatic HR+/HER2- Breast Cancer Who Have Not Received Prior Treatment for Advanced or Metastatic Disease
The purpose of this study is to investigate the efficacy and safety of BGB-43395 in combination with letrozole compared with investigator's choice of cyclin-dependent kinase 4/6 inhibitor (CDK4/6i) in combination with letrozole…
- Trial name
- KANDELA-302 (NCT07492641)
- Testing
- BGB-43395, Letrozole, Abemaciclib
- Where
- 241 sites in United States, Australia and 14 more
- Volunteers
- 1,056 people
- Sponsor
- BeOne Medicines
Breast Cancer
Endocrine Therapy With or Without Abemaciclib (LY2835219) Following Surgery in Participants With Breast Cancer
The purpose of this study is to evaluate the safety and efficacy of the study drug abemaciclib in participants with high risk, node positive, early stage, hormone receptor positive (HR+), human epidermal receptor 2 negative…
- Trial name
- monarchE (NCT03155997)
- Testing
- Abemaciclib, Standard Adjuvant Endocrine Therapy
- Where
- 619 sites in United States, Argentina and 36 more
- Volunteers
- 5,637 people
- Sponsor
- Eli Lilly and Company
Metastatic Breast Cancer
A Real-world Analysis of Concomitant Medication Use Among Metastatic Breast Cancer Patients Treated With CDK4/6 Inhibitors
This is a retrospective cohort study to assess the real-world analysis of concomitant medication use among metastatic breast cancer patients treated with CDK4/6 inhibitors utilizing the US Optum research administrative claims…
- Trial name
- NCT05141240
- Testing
- Ribiciclib, Palbociclib, Abemaciclib
- Where
- United States
- Volunteers
- 4,650 people
- Sponsor
- Novartis Pharmaceuticals
Hepatic Insufficiency
A Study of Abemaciclib in Participants With Varying Degrees of Liver Impairment
The study involves a single dose of a study drug called abemaciclib taken by mouth. The purpose of this study will be to measure how much study drug gets into the blood stream and how long the body takes to get rid of it when…
- Trial name
- NCT02387814
- Testing
- Abemaciclib
- Where
- 5 sites in United States
- Volunteers
- 35 people, healthy volunteers welcome
- Sponsor
- Eli Lilly and Company
Breast Cancer
A Study of Nonsteroidal Aromatase Inhibitors Plus Abemaciclib (LY2835219) in Postmenopausal Women With Breast Cancer
The main purpose of this study is to evaluate how effective nonsteroidal aromatase inhibitors (NSAI) plus abemaciclib are in postmenopausal women with breast cancer.
- Trial name
- MONARCH 3 (NCT02246621)
- Testing
- Abemaciclib, Anastrozole, Letrozole
- Where
- 155 sites in United States, Australia and 20 more
- Volunteers
- 493 people
- Sponsor
- Eli Lilly and Company
Glioma
A Study Comparing Abemaciclib Plus Temozolomide to Temozolomide Monotherapy in Children and Young Adults With High-grade Glioma Following Radiotherapy
The purpose of this study is to measure the benefit of adding abemaciclib to the chemotherapy, temozolomide, for newly diagnosed high-grade glioma following radiotherapy.
- Trial name
- NCT06413706
- Testing
- Abemaciclib, Temozolomide
- Where
- 37 sites in United States, Australia and 8 more
- Volunteers
- 45 people
- Sponsor
- Eli Lilly and Company
Healthy
A Study of Abemaciclib in Healthy Participants
The purposes of this study are to determine: The effect of single increasing doses of the study drug, abemaciclib, on healthy participants.
- Trial name
- NCT02677844
- Testing
- Abemaciclib, Loperamide
- Where
- 2 sites in United States
- Volunteers
- 35 people, healthy volunteers welcome
- Sponsor
- Eli Lilly and Company
Breast Cancer
Phase Ib/II Trial of Abemaciclib and Elacestrant in Patients With Brain Metastasis Due to HR+/Her2- Breast Cancer
This is a multi-institutional, single arm, open label, Phase Ib/II study of abemaciclib in combination with elacestrant in patients with HR+/Her2- breast cancer metastatic to the brain.
- Trial name
- NCT04791384
- Testing
- Abemaciclib, Elacestrant
- Where
- 4 sites in United States
- Volunteers
- 5 people
- Sponsor
- Criterium, Inc.
Neoplasms, Breast Neoplasms
This Study in Patients With Different Types of Cancer (Solid Tumours) Aims to Find a Safe Dose of Xentuzumab in Combination With Abemaciclib With or Without Hormonal Therapies. The Study Also Tests How Effective These Medicines Are in Patients With Lung and Breast Cancer
This is a study in adult patients with different types of cancer. The purpose of this study is to find a safe dose of: Xentuzumab in combination with abemaciclib Xentuzumab in combination with abemaciclib and hormonal therapies…
- Trial name
- NCT03099174
- Testing
- Xentuzumab, Abemaciclib, Letrozole
- Where
- 30 sites in United States, Denmark and 5 more
- Volunteers
- 133 people
- Sponsor
- Boehringer Ingelheim
Breast Cancer
A Study of ZN-c5 and Abemaciclib in Participants With Breast Cancer
This is a Phase 1b, open-label, multicenter, dose-escalation study to evaluate the safety, tolerability, pharmacokinetics (PK), and preliminary efficacy of ZN-c5 administered orally in combination with abemaciclib (VERZENIO®) in…
- Trial name
- NCT04514159
- Testing
- ZN-c5, Abemaciclib
- Where
- 5 sites in United States, Poland
- Volunteers
- 14 people
- Sponsor
- Zeno Alpha Inc.
Breast Neoplasms
A Non-interventional Study for Kisqali (Ribociclib) in Combination With an Aromatase Inhibitor for Adjuvant Treatment in Patients With HR+/HER2- Early Breast Cancer at High Risk of Recurrence
This non-interventional observational study evaluates the real-world effectiveness and safety profile of ribociclib in combination with an aromatase inhibitor for adjuvant treatment in patients with HR+/HER2- early breast cancer…
- Trial name
- CAROLEEN (NCT06830720)
- Testing
- ribociclib + AI ± LHRH, abemaciclib + ET ± LHRH, ET mono ± LHRH
- Where
- 287 sites in Austria, Germany
- Volunteers
- 3,250 people
- Sponsor
- Novartis Pharmaceuticals
Advanced Breast Cancer
A Phase Ib/II Study of QLC1401 Combined With CDK4/6 or mTOR Inhibitors in ER+/HER2- Advanced Breast Cancer
This study is an open-label, multicenter, Phase Ib/II clinical trial designed to evaluate the safety, tolerability, efficacy, and pharmacokinetic characteristics of QLC1401 tablets in combination with CDK4/6 inhibitors or mTOR…
- Trial name
- NCT07173556
- Testing
- QLC1401
- Volunteers
- 96 people
- Sponsor
- Qilu Pharmaceutical Co., Ltd.
Breast Cancer
A Study of LOXO-783 in Patients With Breast Cancer/Other Solid Tumors
The main purpose of this study is to learn more about the safety, side effects, and effectiveness of LOXO-783. LOXO-783 may be used to treat breast cancer and other solid tumors that have a change in a particular gene (known as…
- Trial name
- PIKASSO-01 (NCT05307705)
- Testing
- LOXO-783, Fulvestrant, Imlunestrant
- Where
- 50 sites in United States, Australia and 10 more
- Volunteers
- 260 people
- Sponsor
- Eli Lilly and Company
Neoplasms, Child
A Master Protocol (LY900023) That Includes Several Clinical Trials of Drugs for Children and Young Adults With Cancer
The main purpose of the master is to help the research sites and sponsor carry out several clinical trials more efficiently by providing a common research protocol.
- Conditions
- Neoplasms, Child, Adolescent
- Trial name
- CAMPFIRE (NCT05999994)
- Testing
- Ramucirumab, Cyclophosphamide, Vinorelbine
- Where
- 72 sites in United States, Australia and 8 more
- Volunteers
- 105 people
- Sponsor
- Eli Lilly and Company
Advanced Cancer, Colorectal Cancer
A Study in Advanced Cancers Using Ramucirumab (LY3009806) and Other Targeted Agents
The main purpose of this study is to evaluate the safety of ramucirumab in combination with other targeted agents in participants with advanced cancers.
- Conditions
- Advanced Cancer, Colorectal Cancer, Mantle Cell Lymphoma
- Trial name
- NCT02745769
- Testing
- Ramucirumab, Merestinib, Abemaciclib
- Where
- 5 sites in United States, France and 1 more
- Volunteers
- 23 people
- Sponsor
- Eli Lilly and Company
Prostatic Neoplasms, Neoplasm Metastasis
A Study of Abemaciclib (LY2835219) With Abiraterone in Men With Prostate Cancer That Has Spread to Other Parts of the Body and is Expected to Respond to Hormonal Treatment (Metastatic Hormone-Sensitive Prostate Cancer)
The purpose of this study is to learn whether adding abemaciclib to abiraterone plus prednisone prolongs the time before prostate cancer gets worse. Participation may last approximately 60 months.
- Conditions
- Prostatic Neoplasms, Neoplasm Metastasis, Urogenital Neoplasms, Physiological Effects of Drugs
- Trial name
- CYCLONE 3 (NCT05288166)
- Testing
- Abemaciclib, Abiraterone, Prednisone or Prednisolone
- Where
- 266 sites in United States, Argentina and 22 more
- Volunteers
- 925 people
- Sponsor
- Eli Lilly and Company
Non Small Cell Lung Cancer, Breast Cancer
A Study of Abemaciclib (LY2835219) in Participants With Non-Small Cell Lung Cancer or Breast Cancer
The main purpose of this study is to evaluate the safety and efficacy of abemaciclib in combination with pembrolizumab in participants with advanced non-small cell lung cancer (NSCLC) or hormone receptor positive (HR+), human…
- Trial name
- NCT02779751
- Testing
- Abemaciclib, Pembrolizumab, Anastrozole
- Where
- 24 sites in United States, Belgium and 5 more
- Volunteers
- 100 people
- Sponsor
- Eli Lilly and Company
Breast Cancer, Breast Cancer Metastatic
Open-Label Study to Evaluate the Safety, Tolerability, PK, and Efficacy of INX-315 in Patients With Advanced Cancer
Incyclix Bio (Incyclix) is developing INX-315 as an oral, small molecule inhibitor of cyclin dependent kinase 2 (CDK2) for the treatment of human cancers.
- Conditions
- Breast Cancer, Breast Cancer Metastatic, Hormone Receptor Positive Tumor, Human Epidermal Growth Factor 2 Negative Carcinoma of Breast
- Trial name
- INX-315-01 (NCT05735080)
- Testing
- INX-315, Fulvestrant, Abemaciclib
- Where
- 18 sites in United States, Australia
- Volunteers
- 150 people
- Sponsor
- Incyclix Bio