Clinical trials: Abemaciclib
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
Neurofibromatosis 1
Cyclin-Dependent Kinase (CDK)4/6 Inhibitor Abemaciclib for Neurofibromatosis Type I (NF1) Related Atypical Neurofibromas
Background: NF1 is a genetic disease that causes tumors called atypical neurofibromas. These tumors, which arise from nerves, can cause serious medical problems. The only treatment is surgery.
- Trial name
- NCT04750928
- Testing
- Abemaciclib
- Where
- United States
- Volunteers
- 55 people
- Sponsor
- National Cancer Institute (NCI)
Breast Cancer, ER-positive Breast Cancer
Levels of Circulating Tumor DNA as a Predictive Marker for Early Switch in Treatment for Patients With Metastatic (Stage IV) Breast Cancer
The majority of patients (pts) with breast cancer have hormone receptor positive (HR+) disease, and this holds true for pts with advanced breast cancer (ABC).
- Conditions
- Breast Cancer, ER-positive Breast Cancer, HER2-negative Breast Cancer, Metastatic Breast Cancer
- Trial name
- NCT05826964
- Testing
- AI+CDK4/6i, SERD+CDK4/6i, mTOR inhibitor + AI
- Where
- United States
- Volunteers
- 24 people
- Sponsor
- University of Miami
Endometrial Cancer, Recurrent Endometrial Cancer
ALPINE: Maintenance Letrozole/Abemaciclib
The purpose of this research study is to see if the study drugs abemaciclib and letrozole are effective and safe for participants with estrogen-receptor positive (ER+), mismatch repair proficient, tumor protein p53 (TP53)…
- Conditions
- Endometrial Cancer, Recurrent Endometrial Cancer, TP53
- Trial name
- NCT06366347
- Testing
- Abemaciclib, Letrozole, Pembrolizumab
- Where
- 8 sites in United States
- Volunteers
- 32 people
- Sponsor
- Dana-Farber Cancer Institute
Hormone Receptor-positive Breast Cancer, Hormone Receptor Positive HER-2 Negative Breast Cancer
Phase 1/2 Study to Evaluate EP0062 as Monotherapy and in Combination in Patients With Advanced or Metastatic AR+/HER-2-/ER+ Breast Cancer
The aim of this study is to identify the optimal dose for EP0062 as monotherapy and in combination with standard-of-care therapies to assess its Safety, Tolerability, Pharmacokinetics, and Efficacy in Patients with Relapsed…
- Conditions
- Hormone Receptor-positive Breast Cancer, Hormone Receptor Positive HER-2 Negative Breast Cancer, Metastatic Breast Cancer
- Trial name
- NCT05573126
- Testing
- EP0062, Elacestrant, Everolimus
- Where
- 14 sites in United States, Spain and 1 more
- Volunteers
- 95 people
- Sponsor
- Ellipses Pharma
Metastatic Breast Cancer, ER+ Breast Cancer
Fulvestrant, Ipatasertib and CDK4/6 Inhibition in Metastatic ER+/HER2- Breast Cancer Patients Without ctDNA Suppression
Analysis of circulating tumour DNA (ctDNA) found in a patient's peripheral blood can identify cancer progression and predict a patient's response to therapy.
- Conditions
- Metastatic Breast Cancer, ER+ Breast Cancer, Advanced Breast Cancer
- Trial name
- FAIM (NCT04920708)
- Testing
- Ipatasertib 300mg, Fulvestrant 500g, Palbociclib 75mg-125mg
- Where
- 13 sites in United Kingdom
- Volunteers
- 57 people
- Sponsor
- Royal Marsden NHS Foundation Trust
Breast Cancer, Advanced Breast Cancer
A Study of LY3484356 in Participants With Advanced or Metastatic Breast Cancer or Endometrial Cancer
The reason for this study is to see if the study drug LY3484356 alone or in combination with other anticancer therapies is safe and effective in participants with advanced or metastatic breast cancer or endometrial cancer.
- Conditions
- Breast Cancer, Advanced Breast Cancer, Metastatic Breast Cancer, Endometrial Cancer
- Trial name
- EMBER (NCT04188548)
- Testing
- LY3484356, Abemaciclib, Everolimus
- Where
- 74 sites in United States, Australia and 6 more
- Volunteers
- 379 people
- 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 Neoplasms, Carcinoma, Ductal, Breast
Signatera-Guided CDK4/6 Inhibitor Therapy in Breast Cancer
The purpose of this study is to evaluate the efficacy and safety of ctDNA-guided initiation of CDK4/6 inhibitor therapy using the Signatera™ Designed on Genome test (referred to as "Signatera Genome") in participants with…
- Conditions
- Breast Neoplasms, Carcinoma, Ductal, Breast, Receptors, Estrogen (for ER-positive Requirement)
- Trial name
- SIGNAL-ER 101 (NCT07214532)
- Testing
- ctDNA-Guided Treatment Strategy
- Where
- 49 sites in United States
- Volunteers
- 725 people
- Sponsor
- Natera, Inc.
Hormone Receptor Positive Breast Cancer, HER-2 Positive Breast Cancer
A Study of Abemaciclib (LY2835219) in Women With HR+, HER2+ Locally Advanced or Metastatic Breast Cancer
The purpose of this study is to evaluate the effectiveness of abemaciclib plus trastuzumab with or without fulvestrant versus trastuzumab plus physicians choice standard of care chemotherapy in women with hormone receptor…
- Trial name
- monarcHER (NCT02675231)
- Testing
- Abemaciclib, Trastuzumab, Fulvestrant
- Where
- 93 sites in United States, Argentina and 12 more
- Volunteers
- 237 people
- Sponsor
- Eli Lilly and Company
Breast Cancer
Tucatinib + Abemaciclib + Herceptin for HER2+ MBC
This research study is studying a combination of drugs as a possible treatment for HER2-Postive Metastatic Breast Cancer. The interventions involved in this study are: Tucatinib Abemaciclib (VerzenioTM) Trastuzumab (Herceptin®)…
- Trial name
- NCT03846583
- Testing
- Tucatinib, Abemaciclib, Trastuzumab
- Sponsor
- Dana-Farber Cancer Institute
Solid Tumor, Breast Cancer
A Study of LY3039478 in Participants With Advanced or Metastatic Solid Tumors
The main purpose of this study is to evaluate the safety of the study drug known as LY3039478 in combination with other anticancer agents in participants with advanced or metastatic solid tumors.
- Conditions
- Solid Tumor, Breast Cancer, Colon Cancer, Cholangiocarcinoma
- Trial name
- NCT02784795
- Testing
- LY3039478, Taladegib, Abemaciclib
- Where
- 11 sites in United States, Denmark and 2 more
- Volunteers
- 94 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
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
Gut and Tumor Microbiome in Patients With Early Stage (II-III), Locally Advanced or Advanced ER-positive and HER2-negative Breast Cancer.
The purpose of this research study is to collect samples of blood and stool and analyse primary tumor from participants with breast cancer to see how the bacteria in the body affect cancer and how well it responds to treatment.
- Trial name
- NCT06126003
- Testing
- Observation
- Where
- 6 sites in United States
- Volunteers
- 2 people
- Sponsor
- BioCorteX Inc