Clinical trials: Abemaciclib, completed
Esophageal Adenocarcinoma, Esophagus SCC
Multiorgan Metabolic Imaging Response Assessment of Abemaciclib
Open-label, phase II, basket trial. This trial is a screening program for abemaciclib efficacy in multiple platinum-resistant tumour types by using metabolic imaging (PERCIST) and RECIST v1.1 criteria.
- Conditions
- Esophageal Adenocarcinoma, Esophagus SCC, Cholangiocarcinoma, Urothelial/Bladder Cancer, Nos
- Trial name
- MiMe-A (NCT03339843)
- Testing
- Abemaciclib
- Where
- 11 sites in Belgium, France
- Volunteers
- 85 people
- Sponsor
- Jules Bordet Institute
HNSCC, Head and Neck Neoplasms
Korean Cancer Study Group: Translational bIomarker Driven UMbrella Project for Head and Neck (TRIUMPH), Esophageal Squamous Cell Carcinoma- Part 1 (HNSCC)]
Open, multicenter, single arm, phase II, biomarker driven umbrella trial for head and neck squamous cell carcinoma
- Trial name
- NCT03292250
- Testing
- BYL719, Poziotinib, Nintedanib
- Where
- South Korea
- Volunteers
- 180 people
- Sponsor
- Seoul National University Hospital
Small-cell Lung Cancer, Large Cell Neuroendocrine Carcinoma of the Lung
Targeted Therapy With CDK4/6 Inhibitors in Chemo-Refractory, Rb Wild-Type Extensive SCLC
The purpose of this study is to: Test how well the study medicine Abemaciclib, a CDK4/6 inhibitor, works to shrink lung cancer tumors in the body.
- Conditions
- Small-cell Lung Cancer, Large Cell Neuroendocrine Carcinoma of the Lung, Extrapulmonary Small Cell Carcinoma
- Trial name
- NCT04010357
- Testing
- Abemaciclib,
- Where
- United States
- Volunteers
- 14 people
- Sponsor
- Case Comprehensive Cancer Center
Neoplasm Metastasis
A Study of Abemaciclib in Participants With Cancer That is Advanced or Has Spread to Another Part(s) of the Body
This study is known as a "drug interaction study" and is being done to see how abemaciclib may affect the blood levels of a drug mixture of commonly used drugs (caffeine, warfarin, dextromethorphan, and midazolam) when taken in…
- Trial name
- NCT02688088
- Testing
- Drug Cocktail, Abemaciclib
- Where
- 5 sites in United States
- Volunteers
- 48 people
- Sponsor
- Eli Lilly and Company
Breast Cancer
Treatment Landscape and Real-World Dosing Patterns With CDK4/6 Inhibitors for Breast Cancer in Portugal
Assess and characterize the real-world cyclin-dependent kinase 4/6 inhibitor (CDKI) use in advanced/metastatic breast cancer (a/mBC), evaluate treatment persistence, and quantify CDKI dose adjustments in Portugal.
- Trial name
- PORTRAIT (NCT07223476)
- Where
- United States
- Volunteers
- 1,926 people
- Sponsor
- Novartis Pharmaceuticals
Hormone Receptor Positive Breast Cancer, Metastatic Breast Cancer
CDK4/6-inhibitor or Chemotherapy, in Combination with ENDOcrine Therapy, for Advanced Breast Cancer / KENDO
Prospective, open label, multicenter, group sequential response adaptive randomized phase 2 study, comparing two treatments for locally advanced or metastatic luminal breast cancer: Arm A: concomitant cyclin-dependent Kinase 4/6…
- Conditions
- Hormone Receptor Positive Breast Cancer, Metastatic Breast Cancer, Hormone Receptor Negative Breast Cancer
- Trial name
- KENDO (NCT03227328)
- Testing
- concomitant cyclin-dependent Kinase 4/6 (CDK4/6) inhibitor plus endocrine therapy, chemotherapy plus endocrine therapy (administered either concomitantly or sequentially)
- Where
- 20 sites in Italy
- Volunteers
- 52 people
- Sponsor
- Istituto Romagnolo per lo Studio dei Tumori Dino Amadori IRST S.r.l. IRCCS
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
DILI
Characteristics and Predictors of Liver Injury in Cyclin-dependent Kinase Inhibitors 4/6 (CDK4/6)-Treated Patients With Advanced Breast Cancer
The main objective of the study is to evaluate the presence of predictors (single characteristics at the baseline and / or a combination of two or more parameters) useful for predicting the development of Drug-Induced liver…
- Trial name
- ETIC (NCT06367335)
- Testing
- Ribociclib, palbociclib, abemaciclib
- Where
- Italy
- Volunteers
- 128 people
- Sponsor
- University of Milano Bicocca
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
Carcinoma, Non-Small-Cell Lung, Neoplasm Metastasis
A Study of Necitumumab and Abemaciclib in Participants With Non-Small Cell Lung Cancer (NSCLC)
This is medical research evaluating the safety and efficacy of two new medicines (necitumumab and abemaciclib), administered in combination in participants affected by a defined type of advanced lung cancer (stage IV…
- Trial name
- NCT02411591
- Testing
- Necitumumab, Abemaciclib
- Where
- 15 sites in Belgium, France and 1 more
- Volunteers
- 66 people
- Sponsor
- Eli Lilly and Company
Metastatic Breast Cancer
A Study of Abemaciclib (LY2835219) In Participants With Previously Treated Breast Cancer That Has Spread
The main purpose of this study is to evaluate whether the study drug known as abemaciclib is effective in treating participants with breast cancer who have already tried other drug treatments.
- Trial name
- MONARCH 1 (NCT02102490)
- Testing
- Abemaciclib
- Where
- 36 sites in United States, Belgium and 2 more
- Volunteers
- 132 people
- Sponsor
- Eli Lilly and Company
Metastatic Breast Cancer, Locally Advanced Breast Cancer
Impact of Endocrine Therapy and Abemaciclib on Host and Tumor Immune Cell Repertoire/Function in Advanced ER+/HER2- Breast Cancer
The purpose of this study is to perform an in depth analysis of changes in the tumor immune microenvironment in patients undergoing treatment with standard of care endocrine therapy and abemaciclib in the advanced setting via…
- Conditions
- Metastatic Breast Cancer, Locally Advanced Breast Cancer, Hormone Receptor Positive Tumor
- Trial name
- NCT04352777
- Testing
- Abemaciclib, Fulvestrant, Aromatase Inhibitors
- Where
- United States
- Volunteers
- 18 people
- Sponsor
- Duke University
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
Hormone Receptor-positive Breast Cancer, HER2-negative Breast Cancer
ONO-4578-06:Phase I Study of ONO-4578 and Letrozole Plus CDK4 /6 Inhibitors in Breast Cancer
This is a multicenter, open-label, non-controlled, phase I study to investigate the tolerability and safety of ONO-4578 used in combination with standard-of-care letrozole and a CDK4/6 inhibitor (palbociclib or Abemaciclib) as…
- Conditions
- Hormone Receptor-positive Breast Cancer, HER2-negative Breast Cancer, Metastatic Breast Cancer, Recurrent Breast Cancer
- Trial name
- NCT06570031
- Testing
- ONO-4578, letrozole, Palbociclib
- Where
- 13 sites in Japan
- Volunteers
- 46 people
- Sponsor
- Ono Pharmaceutical Co., Ltd.
Endometrial Endometrioid Adenocarcinoma
Abemaciclib and Letrozole in Treating Patients With Endometrial Cancer
This early phase I trial studies how well abemaciclib and letrozole work in treating patients with endometrial cancer and determines whether there are changes in patients' cancer cell biomarkers (a genetic feature or specific…
- Trial name
- NCT04049227
- Testing
- Abemaciclib, Letrozole, Therapeutic Conventional Surgery
- Where
- 2 sites in United States
- Volunteers
- 27 people
- Sponsor
- Northwestern University
Mantle Cell Lymphoma
Study of LY2835219 for Mantle Cell Lymphoma
The purpose of this study is to estimate the disease control rate with abemaciclib for relapsed or refractory mantle cell lymphoma.
- Trial name
- NCT01739309
- Testing
- Abemaciclib
- Where
- 7 sites in France, Germany
- Volunteers
- 28 people
- Sponsor
- Eli Lilly and Company
Metastatic Breast Cancer
Description of Treatment Patterns and Description and Comparison of Healthcare Resource Utilization and Costs of Women With Metastatic HR+/HER2- Breast Cancer Treated With CDK4/6 Inhibitors
The study was an observational, retrospective cohort design, using US administrative insurance claims data, to better understand Healthcare resource utilization (HRU) and healthcare costs among women with mBC initiated on a…
- Trial name
- NCT05153135
- Testing
- Ribociclib, Palbociclib, Abemaciclib
- Where
- United States
- Volunteers
- 4,320 people
- Sponsor
- Novartis Pharmaceuticals
Metastatic Esophageal Adenocarcinoma, Metastatic Gastroesophageal Junction Adenocarcinoma
Abemaciclib Plus Ramucirumab for Esophageal/Gastroesophageal Junction Ca
CDK4/6 and Cyclin D1 are significantly expressed in approximately 80% of esophageal and gastroesophageal junction tumors suggesting that CDK4/6 inhibition may be a successful strategy in these chemotherapy and immunotherapy…
- Trial name
- NCT04921904
- Testing
- Abemaciclib, Ramucirumab
- Where
- United States
- Volunteers
- 26 people
- Sponsor
- Baylor Research Institute
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
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