Clinical trials: Abemaciclib
Neoplasm, Neoplasm Metastasis
A Study of LY2835219 in Participants With Cancer
The purpose of this study is to assess how the body handles Abemaciclib when it is given with another drug called clarithromycin.
- Trial name
- NCT02117648
- Testing
- Abemaciclib, Clarithromycin
- Where
- 2 sites in United States
- Volunteers
- 26 people
- Sponsor
- Eli Lilly and Company
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
Healthy
A Study of Abemaciclib in Healthy Participants
The purpose of this study is to measure how much abemaciclib gets into the blood stream and how long it takes the body to get rid of it when given as capsules versus a tablet(s).
- Trial name
- NCT02672423
- Testing
- Abemaciclib Capsules (Reference Formulation), Abemaciclib Tablet (Test Formulation)
- Where
- 2 sites in United States
- Volunteers
- 127 people, healthy volunteers welcome
- Sponsor
- Eli Lilly and Company
Healthy Volunteers
A Study of LY2835219 in Healthy Participants
Participants in this study will receive 3 single oral doses of LY2835219 at least 14 days apart. One dose will be given with a standard meal, one dose with a high-fat meal and one dose without food.
- Trial name
- NCT02059148
- Testing
- LY2835219
- Where
- United States
- Volunteers
- 24 people, healthy volunteers welcome
- Sponsor
- Eli Lilly and Company
Mesothelioma, Malignant
Mesothelioma Stratified Therapy (MiST) : A Multi-drug Phase II Trial in Malignant Mesothelioma
MiST is a British Lung Foundation funded, University of Leicester Study, a multi-arm stratified therapy based clinical trial for patients with relapsed mesothelioma.
- Trial name
- MiST (NCT03654833)
- Testing
- Rucaparib, Abemaciclib, pembrolizumab & bemcentinib
- Where
- United Kingdom
- Volunteers
- 186 people
- Sponsor
- University of Leicester
Breast Neoplasms
A Study of Abemaciclib (LY2835219) Combined With Fulvestrant in Women With Hormone Receptor Positive HER2 Negative Breast Cancer
The main purpose of this study is to compare progression-free survival for women with hormone receptor positive (HR+), human epidermal growth factor receptor (HER2) negative advanced breast cancer receiving either abemaciclib +…
- Trial name
- MONARCH 2 (NCT02107703)
- Testing
- Abemaciclib, Fulvestrant
- Where
- 146 sites in United States, Australia and 18 more
- Volunteers
- 669 people
- Sponsor
- Eli Lilly and Company
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
Head and Neck Squamous Cell Carcinoma
Abemaciclib + Nivolumab in Patients With Recurrent/Metastatic Head and Neck Squamous Cell Carcinoma That Progressed or Recurred Within Six Months After Platinum-based Chemotherapy
In phase I of the trial, the investigators aim to explore the safety and feasibility of abemaciclib in combination with nivolumab in patients with recurrent/metatstatic head and neck squamous cell carcinoma (RM-HNSCC).
- Trial name
- NCT03655444
- Testing
- Abemaciclib, Nivolumab, Tumor biopsy
- Where
- United States
- Volunteers
- 6 people
- Sponsor
- Washington University School of Medicine
Non-Small Cell Lung Cancer Stage IV
A Study of Abemaciclib (LY2835219) in Participants With Stage IV Squamous Non-small Cell Lung Cancer
The main purpose of this study is to evaluate the effectiveness of the study drug known as abemaciclib versus docetaxel in participants with stage IV squamous non-small cell lung cancer (NSCLC) previously treated with…
- Trial name
- NCT02450539
- Testing
- Abemaciclib, Docetaxel
- Where
- 51 sites in United States, Australia and 11 more
- Volunteers
- 159 people
- Sponsor
- Eli Lilly and Company
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
Carcinoma, Non-small Cell Lung
A Study of Abemaciclib (LY2835219) in Combination With Another Anti-cancer Drug in Participants With Lung Cancer (NSCLC)
The main purpose of this study is to evaluate the safety and tolerability of abemaciclib in combination with another anti-cancer drug in participants with NSCLC that is advanced or has spread to other parts of the body (stage…
- Trial name
- NCT02079636
- Testing
- Abemaciclib, Pemetrexed, Gemcitabine
- Where
- 11 sites in United States, Spain
- Volunteers
- 142 people
- Sponsor
- Eli Lilly and Company
Breast Cancer
A Study of Abemaciclib (LY2835219) in Participants With Breast Cancer
The main purpose of this study is to evaluate the efficacy of the study drug abemaciclib in postmenopausal women with hormone receptor-positive (HR+), human epidermal growth factor receptor 2-negative (HER2-) locoregionally…
- Trial name
- MONARCH plus (NCT02763566)
- Testing
- Abemaciclib, Anastrozole, Letrozole
- Where
- 45 sites in Brazil, China and 2 more
- Volunteers
- 463 people
- Sponsor
- Eli Lilly and Company
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
Glioma
Abemaciclib Neuropharmacokinetics of Diffuse Midline Glioma Using Intratumoral Microdialysis
Background: Diffuse midline gliomas are the most aggressive brain tumors of childhood and young adults. Most people with these tumors survive less than 2 years.
- Trial name
- NCT05413304
- Testing
- Pre-operative abemaciclib, Device for Cerebral Fluid Dialysate Collection, Ashion Analytics GEM ExTra
- Where
- United States
- Volunteers
- 5 people
- Sponsor
- National Cancer Institute (NCI)
Pancreatic Ductal Adenocarcinoma
A Study of Abemaciclib (LY2835219) Alone or in Combination With Other Agents in Participants With Previously Treated Pancreatic Ductal Adenocarcinoma
The purpose of this study is to evaluate the safety and efficacy of abemaciclib alone and in combination with other drugs versus standard of care in participants with previously treated metastatic pancreatic ductal adenocarcinoma…
- Trial name
- NCT02981342
- Testing
- Abemaciclib, LY3023414, Gemcitabine
- Where
- 32 sites in United States, Australia and 6 more
- Volunteers
- 106 people
- Sponsor
- Eli Lilly and Company
Biliary Tract Carcinoma
A Study to Evaluate Abemaciclib in Advanced Biliary Tract Carcinoma
The prognosis of patients with recurrent, late-stage inoperable, or progressed biliary tract carcinoma (BTC) is generally poor. The goal of this clinical study is to determine the effectiveness and safety of abemaciclib in…
- Trial name
- NCT04003896
- Testing
- Abemaciclib
- Where
- United States
- Volunteers
- 4 people
- Sponsor
- Milton S. Hershey Medical Center
Healthy Volunteers
A Study of LY2835219 in Healthy Participants
The aim of this two-period 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 when it is given as a single oral dose in combination with rifampin (a Food and Drug…
- Trial name
- NCT02256267
- Testing
- LY2835219, Rifampin
- Where
- United States
- Volunteers
- 24 people, healthy volunteers welcome
- Sponsor
- Eli Lilly and Company
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
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
Clear Cell Renal Cell Carcinoma
ABEMA Alone or in COMBO With MK-6482
This research study will assess whether abemaciclib alone or in combination with MK-6482 are safe and effective in slowing down the growth of clear cell renal cell carcinoma (ccRCC).
- Trial name
- NCT04627064
- Testing
- Abemaciclib, MK-6482
- Where
- United States
- Volunteers
- 11 people
- Sponsor
- Dana-Farber Cancer Institute