Clinical trials: Abemaciclib
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
Breast Cancer
A Real-World Study of Early Breast Cancer Patients Eligible for Treatment With CDK4/6 Inhibitors
The aim of this study was to describe treatment patterns, patient characteristics and clinical outcomes among hormone receptor positive/human epidermal growth factor receptor 2 negative (HR+/HER2-) early breast cancer (eBC)…
- Trial name
- LEEWARD (NCT07647042)
- Where
- United States
- Volunteers
- 750 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
Liver Metastases From Colorectal Cancer (mCRC)
Abemaciclib Combined With FOLFOX/FOLFIRI Regimen in Patients With Advanced Colorectal Liver Metastases Cancer
This is a single-center, single-arm, open-label clinical study, to explore the efficacy and safety of abemaciclib combined with FOLFOX/FOLFIRI regimen in patients with advanced colorectal liver metastases cancer who failed…
- Trial name
- NCT07441369
- Testing
- Abemaciclib, Oxaliplatin, Calcium Folinate
- Where
- China
- Volunteers
- 16 people
- Sponsor
- Fudan University
The Incidence of AEs and SAEs Receiving Verzenios® Over a Period of Approximately 24 Weeks
A Prospective Post-Marketing Observational Safety Study of Verzenios® (Abemaciclib) Among Breast Cancer Patients in China Verzenios® (Abemaciclib) Among Breast
This PMSS is a single-country, prospective, observational study primarily designed to estimate the incidence of AEs and SAEs among Chinese patients with breast cancer after receiving Verzenios® over a period of approximately 24…
- Trial name
- NCT05267327
- Testing
- Verzenios
- Volunteers
- 1,500 people
- Sponsor
- Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
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
Low Grade Serous Ovarian Carcinoma, Adult Type Granulosa Cell Tumor
Abemaciclib and Letrozole in Patients With Estrogen Receptor-positive Rare Ovarian Cancer
The purpose of this study is to assess the efficacy and safety of abemaciclib and letrozole for treatment of estrogen receptor-positive rare ovarian cancer.
- Trial name
- ALEPRO (NCT05872204)
- Testing
- Abemaciclib, Letrozole
- Where
- 12 sites in Belgium, France and 1 more
- Volunteers
- 100 people
- Sponsor
- Universitaire Ziekenhuizen KU Leuven
Meningioma
Abemaciclib in Newly Diagnosed Meningioma Patients
This study is being done to learn about how an investigational drug called abemaciclib works in treating patients with a newly-diagnosed grade 3 meningioma.
- Trial name
- NCT05940493
- Testing
- Abemaciclib
- Where
- United States
- Volunteers
- 72 people
- Sponsor
- Nader Sanai
Breast Cancer Stage III, Breast Cancer Stage II
The Efficacy and Safety of CDK4/6 Inhibitors in Combination with Endocrine Therapy in the Neoadjuvant Treatment
To explore the efficacy and safety of CDK4/6 inhibitors combined with endocrine neoadjuvant therapy for stage II-III HR-positive/HER2-negative breast cancer.
- Trial name
- NCT06810492
- Testing
- Ribociclib; abemaciclib; palbociclib; Dalpiciclib
- Volunteers
- 40 people
- Sponsor
- Hongmei Zheng, PhD
Breast Cancer
A Study to Evaluate the Effect of GDC-4198 Alone and in Combination With Giredestrant Versus Abemaciclib and Giredestrant in Participants With Locally Advanced or Metastatic Estrogen Receptor-Positive (ER+), Human Epidermal Growth Factor Receptor-Negative (HER2-) Breast Cancer
The purpose of this study is to assess the safety of GDC-4198 alone and in combination with giredestrant and also the efficacy of GDC-4198 + giredestrant versus abemaciclib + giredestrant in participants with locally advanced or…
- Trial name
- MoonROSE (NCT07100106)
- Testing
- GDC-4198, Giredestrant, Abemaciclib
- Where
- 77 sites in United States, Australia and 8 more
- Volunteers
- 285 people
- Sponsor
- Genentech, Inc.
HR+/HER2- Early Breast Cancer
Patient Relevant Outcomes Improvement Program in High Risk Hormone Receptor Positive (HR+) Breast Cancer
The goal of this observational study is to evaluate how persistently patients with high-risk early breast cancer take abemaciclib 6 months after therapy start.
- Trial name
- PROSPER (NCT07531693)
- Where
- Germany
- Volunteers
- 200 people
- Sponsor
- Institut fuer Frauengesundheit
Anatomic Stage III Breast Cancer AJCC v8, Anatomic Stage IV Breast Cancer AJCC v8
Testing the Safety and Efficacy of the Combination of Two Anti-cancer Drugs, ZEN003694 and Abemaciclib, for Adult and Pediatric Patients (12-17 Years) With Metastatic or Unresectable NUT Carcinoma, Breast Cancer and Other Solid Tumors
This phase I trial tests the safety, side effects, and best dose of ZEN003694 when given together with abemaciclib in treating patients with NUT carcinoma, breast cancer or other solid tumors that have spread from where it first…
- Conditions
- Anatomic Stage III Breast Cancer AJCC v8, Anatomic Stage IV Breast Cancer AJCC v8, Metastatic Breast Carcinoma, Metastatic Malignant Solid Neoplasm
- Trial name
- NCT05372640
- Testing
- Abemaciclib, BET Bromodomain Inhibitor ZEN-3694, Biopsy Procedure
- Where
- 7 sites in United States
- Volunteers
- 45 people
- Sponsor
- National Cancer Institute (NCI)
Advanced Cancer, Metastatic Cancer
A Study of LY3023414 in Participants With Advanced Cancer
The purpose of this study is to find a recommended dose level and schedule of dosing LY3023414 that can safely be taken by participants with advanced or metastatic cancer.
- Conditions
- Advanced Cancer, Metastatic Cancer, Non-Hodgkin's Lymphoma, Metastatic Breast Cancer
- Trial name
- NCT01655225
- Testing
- LY3023414, Midazolam, Fulvestrant
- Where
- 8 sites in United States, Italy and 1 more
- Volunteers
- 156 people
- Sponsor
- Eli Lilly and Company
Prostate Cancer
Abemaciclib With or Without Atezolizumab in Metastatic Castration Resistant Prostate Cancer
This research is studying two experimental drugs, abemaciclib and atezolizumab, alone and in combination with each other, to learn about the safety and effectiveness of these treatments and their side effects.
- Trial name
- NCT04272645
- Testing
- Abemaciclib 200 MG, Atezolizumab 1200 MG in 20 ML Injection, Abemaciclib 150 MG
- Where
- 4 sites in United States
- Sponsor
- University of Michigan Rogel Cancer Center
Breast Cancer
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
The purpose of this study is to determine the safety and efficacy of PF-07220060 with letrozole compared to approved treatments (ie, palbociclib, ribociclib or abemaciclib with letrozole) in people with breast cancer: HR-positive…
- Trial name
- FourLight-3 (NCT06760637)
- Testing
- PF-07220060, letrozole, abemaciclib
- Where
- 460 sites in United States, Argentina and 28 more
- Volunteers
- 1,035 people
- Sponsor
- Pfizer
Breast Cancer
RADIANT: Pre-op Radiation With Abemaciclib and Letrozole
This phase 1b study investigates the safety and feasibility of combining pre-operative radiation therapy with Cyclin-Dependent Kinase 4 (CDK4/6) inhibitors in participants with hormone receptor positive/HER2 negative (HR+/HER2-)…
- Trial name
- NCT06139107
- Testing
- Abemaciclib, Letrozole
- Where
- 4 sites in United States
- Volunteers
- 15 people
- Sponsor
- Mridula George, MD
Breast Cancer
Study to Understand Relationship Between Gut Health and Toxicities of Hormonal Breast Cancer Treatment
This study will be conducted in 2 sequential parts. The first part will be a prospective, observational study. This will be followed by a small interventional, pilot study involving use of fiber supplement (chia seeds).
- Trial name
- GEMMA (NCT07553234)
- Testing
- Stool Sampling, Chia Seeds
- Where
- United States
- Volunteers
- 20 people
- Sponsor
- University of Chicago
Metastatic Breast Cancer, Breast Cancer Stage I
A Phase Ib/II Study to Evaluate Multiple Combination Therapies of FWD1802 in Patients With ER+/HER2- BC
This is a Study to Evaluate the Efficacy and Safety of Multiple Combination Therapies with FWD1802 in Subjects with ER-positive/HER2-negative Unresectable Locally Advanced or Metastatic Breast Cancer
- Conditions
- Metastatic Breast Cancer, Breast Cancer Stage I, Breast Cancer Stage II, Locally Advanced Breast Cancer (LABC)
- Trial name
- NCT07002177
- Testing
- FWD1802, Palbociclib 125mg, Ribociclib 200Mg Oral Tablet
- Where
- China
- Volunteers
- 196 people
- Sponsor
- Forward Pharmaceuticals Co., Ltd.
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