Clinical trials: Abemaciclib
Metastatic Castration-Resistant Prostate Cancer
Abemaciclib (LY2835219) in Men With Heavily Treated Metastatic Castration-Resistant Prostate Cancer
The study will evaluate how safe and effective abemaciclib is when given to participants whose metastatic prostate cancer progresses after they had received several previous treatments.
- Trial name
- CYCLONE 1 (NCT04408924)
- Testing
- Abemaciclib
- Where
- 14 sites in United States, France and 1 more
- Volunteers
- 44 people
- Sponsor
- Eli Lilly and Company
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 Neoplasm, Neoplasm Metastasis
Abemaciclib (LY2835219) Plus Fulvestrant Compared to Placebo Plus Fulvestrant in Previously Treated Breast Cancer
This study will evaluate the effect of adding abemaciclib to fulvestrant for the treatment of hormone receptor-positive (HR+), human epidermal growth factor receptor 2-negative (HER2-) breast cancer that progressed or recurred…
- Trial name
- postMONARCH (NCT05169567)
- Testing
- Abemaciclib, Fulvestrant
- Where
- 138 sites in United States, Argentina and 15 more
- Volunteers
- 368 people
- Sponsor
- Eli Lilly and Company
Neoplasm Metastasis, Lymphoma
A Study of LY2835219 in Japanese Participants With Advanced Cancer
The main purpose of this study is to evaluate safety and side effects of LY2835219 in Japanese participants with advanced cancer.
- Trial name
- NCT02014129
- Testing
- LY2835219
- Where
- Japan
- Volunteers
- 12 people
- Sponsor
- Eli Lilly and Company
Metastatic Breast Cancer
Expanded Access Program to Provide Abemaciclib (LY2835219) for the Treatment of Metastatic Breast Cancer
The treating physician/investigator contacts Lilly when, based on their medical opinion, a patient meets the criteria for inclusion in the expanded access program.
- Trial name
- NCT02792725
- Testing
- Abemaciclib
- Where
- 10 sites in United States
- Sponsor
- Eli Lilly and Company
Healthy Volunteers
A Study of LY2835219 in Healthy Participants
The aim of this study is to compare how much of the study drug gets into the blood stream when it is given as a single oral dose and as an intravenous infusion (given directly into a vein via a small needle).
- Trial name
- NCT02327143
- Testing
- LY2835219, ¹³C₈-LY2835219
- Where
- United Kingdom
- Volunteers
- 11 people, healthy volunteers welcome
- Sponsor
- Eli Lilly and Company
Prostate Cancer
A Study of Abiraterone Acetate Plus Prednisone With or Without Abemaciclib (LY2835219) in Participants With Prostate Cancer
This study is being done to see how safe and effective abemaciclib is when given together with abiraterone acetate plus prednisone in participants with metastatic castration resistant prostate cancer.
- Trial name
- CYCLONE 2 (NCT03706365)
- Testing
- Abemaciclib, Abiraterone acetate, Prednisone
- Where
- 112 sites in United States, Australia and 9 more
- Volunteers
- 393 people
- Sponsor
- Eli Lilly and Company
Breast Cancer
Phase 1/2 Study of Amcenestrant (SAR439859) Single Agent and in Combination With Other Anti-cancer Therapies in Postmenopausal Women With Estrogen Receptor Positive Advanced Breast Cancer
Primary Objectives: Dose Escalation: To assess the incidence rate of dose-limiting toxicity (DLT) and to determine the maximum tolerated dose (MTD) as well as the recommended dose (RD) of amcenestrant administered as monotherapy…
- Trial name
- AMEERA-1 (NCT03284957)
- Testing
- Amcenestrant, Palbociclib, Alpelisib
- Where
- 25 sites in United States, Belgium and 8 more
- Volunteers
- 136 people
- Sponsor
- Sanofi
Advanced Solid Tumor, Non-Small Cell Lung Cancer
A Study of LY3499446 in Participants With Advanced Solid Tumors With KRAS G12C Mutation
The reason for this study is to see if the study drug LY3499446 is safe and effective in participants with solid tumors with KRAS G12C mutation.
- Conditions
- Advanced Solid Tumor, Non-Small Cell Lung Cancer, Colorectal Cancer
- Trial name
- NCT04165031
- Testing
- LY3499446, Abemaciclib, Cetuximab
- Where
- 6 sites in United States, Australia
- Volunteers
- 5 people
- Sponsor
- Eli Lilly and Company
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
Healthy
A Study of Abemaciclib (LY2835219) in Healthy Participants With and Without Food
The purpose of this study is to evaluate the amount of abemaciclib that reaches the blood stream and how long the body takes to get rid of it when given with and without food.
- Trial name
- NCT02482935
- Testing
- Abemaciclib
- Where
- 2 sites in United States
- Volunteers
- 30 people, healthy volunteers welcome
- Sponsor
- Eli Lilly and Company
Breast Cancer, Non-small Cell Lung Cancer
A Study of Abemaciclib (LY2835219) in Participants With Breast Cancer, Non-small Cell Lung Cancer, or Melanoma That Has Spread to the Brain
The main purpose of this study is to evaluate the safety and effectiveness of the study drug known as abemaciclib in participants with hormone receptor positive breast cancer, non-small cell lung cancer (NSCLC), or melanoma that…
- Conditions
- Breast Cancer, Non-small Cell Lung Cancer, Melanoma, Brain Metastases
- Trial name
- NCT02308020
- Testing
- Abemaciclib
- Where
- 44 sites in United States, Australia and 7 more
- Volunteers
- 162 people
- Sponsor
- Eli Lilly and Company
Breast Neoplasms
A Study of Multiple Immunotherapy-Based Treatment Combinations in Hormone Receptor (HR)-Positive Human Epidermal Growth Factor Receptor 2 (HER2)-Negative Breast Cancer
This study is designed to evaluate the efficacy, safety, and pharmacokinetics of several immunotherapy-based combination treatments in participants with inoperable locally advanced or metastatic HR-positive, HER2-negative breast…
- Trial name
- MORPHEUS HR+BC (NCT03280563)
- Testing
- Atezolizumab (MPDL3280A), an engineered anti-programmed death-ligand 1 (PD-L1) antibody, Bevacizumab, Entinostat
- Where
- 22 sites in United States, Israel and 1 more
- Volunteers
- 144 people
- Sponsor
- Hoffmann-La Roche
ER+ HER2- Advanced Breast Cancer, High-grade Serous Ovarian Cancer (HGSOC)
A First-in-human Dose Escalation and Expansion Study to Evaluate the Safety, and Tolerability of AZD8421 Alone or in Combination in Participants With Selected Advanced or Metastatic Solid Tumors
This study is designed to evaluate AZD8421 alone and in combination with selected targeted anti-cancer drugs in patients with ER+HER2- advanced breast cancer, and patients with metastatic high-grade serious ovarian cancer.
- Trial name
- CYCAD-1 (NCT06188520)
- Testing
- AZD8421, Camizestrant, Ribociclib
- Where
- 13 sites in United States, Australia and 3 more
- Volunteers
- 55 people
- Sponsor
- AstraZeneca
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
Advanced Cancer
A Study of Abemaciclib (LY2835219) in Combination With Other Anti-Cancer Therapies in Japanese Participants With Advanced Cancer
The purpose of this study is to see if the study drug abemaciclib in combination with other anti-cancer therapies is safe in Japanese participants with advanced cancer.
- Trial name
- NCT04071262
- Testing
- Abemaciclib, Abiraterone Acetate, Prednisolone
- Where
- 2 sites in Japan
- Volunteers
- 6 people
- Sponsor
- Eli Lilly and Company
Inoperable, Locally Advanced or Metastatic, ER-positive Breast Cancer
A Study Evaluating the Efficacy and Safety of Multiple Treatment Combinations in Participants With Breast Cancer
This is a Phase Ib/II, open-label, multicenter, randomized umbrella study in participants with breast cancer. The study is designed with the flexibility to open new treatment arms as new treatments become available, close…
- Trial name
- NCT04802759
- Testing
- Giredestrant, Abemaciclib, Ipatasertib
- Where
- 32 sites in United States, Australia and 3 more
- Volunteers
- 316 people
- Sponsor
- Hoffmann-La Roche
Healthy Volunteers
A Study of Carbon-14-Labeled LY2835219 ([^14C]-LY2835219) in Healthy Participants
This type of study is called a radiolabeled study. For this study, LY2835219 (study drug) has been specially prepared to contain radiolabeled carbon [^14C]. [^14C] is a naturally occurring radioactive form of the element carbon.
- Trial name
- NCT01913314
- Testing
- [^14C]-LY2835219
- Where
- United States
- Volunteers
- 6 people, healthy volunteers welcome
- Sponsor
- Eli Lilly and Company
Breast Cancer, Hormone-receptor-positive Breast Cancer
A Phase 1/1b Study of PRT13722 in Participants With Advanced HR+/HER2- Breast Cancer
This first-in-human, open-label, multicenter study will evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics, and preliminary antitumor activity of PRT13722, an oral KAT6A protein degrader, in adults with locally…
- Conditions
- Breast Cancer, Hormone-receptor-positive Breast Cancer, HER2-negative Breast Cancer, HR-positive Breast Cancer
- Trial name
- NCT07905001
- Testing
- PRT13722, Fulvestrant, Abemaciclib
- Volunteers
- 242 people
- Sponsor
- Prelude Therapeutics Incorporated
Breast Cancer
TACTIVE-U: A Study to Learn About the Study Medicine (Vepdegestrant) When Given With Other Medicines in People With Advanced or Metastatic Breast Cancer (Sub-Study A)
The purpose of this clinical trial is to learn about the safety and effects of the study medicine (called ARV-471) when given together with other medicines for the potential treatment of advanced or metastatic breast cancer.
- Trial name
- NCT05548127
- Testing
- ARV-471, Abemaciclib
- Where
- 37 sites in United States, Canada and 2 more
- Volunteers
- 37 people
- Sponsor
- Pfizer