Clinical trials: Abemaciclib
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)
Anatomic Stage III Breast Cancer AJCC v8, Anatomic Stage IV Breast Cancer AJCC v8
Functional Imaging in Prediction of Response to Abemaciclib for Advanced Hormone Receptor-Positive, HER2-Negative Breast Cancer
This phase II trial tests the accuracy of functional imaging (FFNP)-positron emission tomography (PET)/computed tomography (CT) to predict response to abemaciclib plus endocrine therapy.
- Conditions
- Anatomic Stage III Breast Cancer AJCC v8, Anatomic Stage IV Breast Cancer AJCC v8, Locally Advanced Unresectable HER2-Negative Breast Carcinoma, Locally Advanced Unresectable Hormone Receptor-Positive Breast Carcinoma
- Trial name
- NCT06179303
- Testing
- Abemaciclib, Anastrozole, Biospecimen Collection
- Where
- 3 sites in United States
- Volunteers
- 60 people
- Sponsor
- University of Washington
Breast Neoplasms, Neoplasm Metastasis
A Study of Abemaciclib in Indian Women With Advanced Breast Cancer
The main purpose of this study is to learn more about the safety and tolerability of abemaciclib when given in combination with hormone therapy in Indian women with advanced breast cancer.
- Trial name
- NCT04707196
- Testing
- Abemaciclib, Nonsteroidal Aromatase Inhibitor (NSAI), Fulvestrant
- Where
- 15 sites in India
- Volunteers
- 200 people
- Sponsor
- Eli Lilly and Company
Early Breast Cancer, Hormone Receptor Positive Tumor
Adherence to Aromatase Inhibitors ± Abemaciclib Treatment in Patients With Early-stage HER2-negative Breast Cancer
Around 90% of breast cancer patients are diagnosed at an early stage and approximately 70% are hormone receptor-positive and HER2-negative (HR+/HER2-).
- Conditions
- Early Breast Cancer, Hormone Receptor Positive Tumor, HER2-negative Breast Cancer
- Trial name
- ONCO-Adher (NCT06650423)
- Where
- Slovenia
- Volunteers
- 319 people
- Sponsor
- Institute of Oncology Ljubljana
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
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
Non Small Cell Lung Cancer, Glioma Glioblastoma Multiforme
Safety and Tolerability of TNG456 Alone and in Combination With Abemaciclib in Patients With Solid Tumors With MTAP Loss
This is a first in human study of TNG456 alone and in combination with abemaciclib in patients with advanced or metastatic solid tumors known to have an MTAP loss.
- Conditions
- Non Small Cell Lung Cancer, Glioma Glioblastoma Multiforme, Glioma, Malignant, Solid Tumor
- Trial name
- NCT06810544
- Testing
- TNG456, abemaciclib
- Where
- 15 sites in United States
- Volunteers
- 191 people
- Sponsor
- Tango Therapeutics, Inc.
Renal Cell Carcinoma Metastatic
A Study of Abemaciclib in Combination With Sunitinib in Metastatic Renal Cell Carcinoma
The purpose of this study is to determine the safety, tolerability, and maximal tolerated dose (MTD) of the combination of Abemaciclib and Sunitinib administered orally in patients with advanced and metastatic renal cell…
- Trial name
- NCT03905889
- Testing
- Abemaciclib, Sunitinib
- Where
- United States
- Volunteers
- 3 people
- Sponsor
- Brown University
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
Prostate Cancer, Metastatic Castration-resistant Prostate Cancer
Abemaciclib With or Without Atezolizumab for mCRPC
This trial is testing whether a molecularly targeted chemotherapy drug called abemaciclib and an immunotherapy drug called atezolizumab, alone or in combination, are effective in shrinking or preventing the growth of metastatic…
- Trial name
- NCT04751929
- Testing
- Abemaciclib, Atezolizumab
- Where
- United States
- Volunteers
- 19 people
- Sponsor
- Dana-Farber Cancer Institute
Breast Cancer
Chidamide in Combination With Abemaciclib and Endocrinotherapy（Doctor's Choice） in Breast Cancer Patients Previously Treated With Palbociclib
To evaluate the efficacy and safety of chidamide in combination with abemaciclib and endocrinotherapy（doctor's choice） in locally advanced/metastatic HR+/HER2- breast cancer who had failed prior palbociclib therapy
- Trial name
- CINDERELLA (NCT05464173)
- Testing
- Chidamide, Abemaciclib, endocrinotherapy（doctor's choice）
- Where
- China
- Volunteers
- 44 people
- Sponsor
- Biyun Wang, MD
Breast Cancer
Single Cell Immune and Non-immune Correlates of Response to Neoadjuvant Abemaciclib
The purpose of this study is to better understand how the immune system plays a role in fighting breast cancer and specifically research if the immune system response against breast cancer can be improved with endocrine therapy…
- Trial name
- NCT04614194
- Testing
- Letrozole, Abemaciclib
- Where
- 2 sites in United States
- Volunteers
- 60 people
- Sponsor
- University of Texas Southwestern Medical Center
Recurrent Endometrial Carcinoma, Recurrent Fallopian Tube Carcinoma
Abemaciclib for the Treatment of Recurrent Ovarian or Endometrial Cancer
This phase II trial studies how well abemaciclib works in treating patients with ovarian or endometrial cancer that has an activation of the CDK4/6 pathway and that has come back (recurrent).
- Conditions
- Recurrent Endometrial Carcinoma, Recurrent Fallopian Tube Carcinoma, Recurrent Ovarian Carcinoma, Recurrent Primary Peritoneal Carcinoma
- Trial name
- NCT04469764
- Testing
- Abemaciclib, Anastrozole, Letrozole
- Where
- United States
- Volunteers
- 32 people
- Sponsor
- Jonsson Comprehensive Cancer Center
HR+/HER2- aBC Undergoing 1L Treatment With CDK4/6i (Palbociclib, Abemaciclib or Ribociclib) and AI (Anastrozole or Letrozole)
ESR1Real World Assessment Prevalence Study
Many patients with hormone receptor-positive, human epidermal growth factor receptor 2-negative (HR+/HER2-) advanced breast cancer in the first therapy line is endocrine sensitive.
- Trial name
- ESRA (NCT07817212)
- Testing
- ESR1 testing
- Where
- 21 sites in Germany
- Volunteers
- 1,550 people
- Sponsor
- Institut fuer Frauengesundheit
Breast Cancer, HER-2 Positive Breast Cancer
Gut Microbiome Changes During Abemaciclib Therapy in Breast Cancer
Abemaciclib (Verzenio) is a commonly used treatment for hormone receptor-positive breast cancer, but it can cause gastrointestinal side effects such as diarrhea, which may affect quality of life and treatment tolerance.
- Trial name
- MICRO-VERZ (NCT07406594)
- Testing
- Resistant Potato Starch
- Where
- United States
- Volunteers
- 12 people
- Sponsor
- University of Vermont Medical Center
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 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
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 Neoplasms, Neoplasm Metastasis
A Study of Imlunestrant, Investigator's Choice of Endocrine Therapy, and Imlunestrant Plus Abemaciclib in Participants With ER+, HER2- Advanced Breast Cancer
The main purpose of this study is to measure how well imlunestrant works compared to standard hormone therapy, and how well imlunestrant with abemaciclib work compared to imlunestrant in participants with breast cancer that is…
- Trial name
- EMBER-3 (NCT04975308)
- Testing
- Imlunestrant, Exemestane, Fulvestrant
- Where
- 243 sites in United States, Argentina and 20 more
- Volunteers
- 874 people
- Sponsor
- Eli Lilly and Company
Prostatic Neoplasms
Abemaciclib Plus Darolutamide in Prostate Cancer That Has Spread After Initial Treatment
The main purpose of this study is to learn more about the safety and tolerability of abemaciclib when given in combination with darolutamide to participants with prostate cancer that has spread after initial treatment.
- Trial name
- NCT05999968
- Testing
- Abemaciclib, Darolutamide, LHRH agonist/antagonist
- Where
- 13 sites in United States, Germany and 1 more
- Volunteers
- 10 people
- Sponsor
- Eli Lilly and Company