Clinical trials: Abemaciclib
Metastatic Breast Cancer
A Study of Abemaciclib (LY2835219) Plus Tamoxifen or Abemaciclib Alone in Women With Metastatic Breast Cancer
The main purpose of this study is to evaluate the safety and efficacy of abemaciclib plus tamoxifen or abemaciclib alone in women with previously treated hormone receptor-positive (HR+), human epidermal growth factor receptor 2…
- Trial name
- Next MONARCH 1 (NCT02747004)
- Testing
- Abemaciclib, Tamoxifen, Prophylactic Loperamide
- Where
- 59 sites in United States, Argentina and 12 more
- Volunteers
- 234 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
Breast Cancer, Metastatic Breast Cancer
Open-Label Umbrella Study To Evaluate Safety And Efficacy Of Elacestrant In Various Combination In Participants With Metastatic Breast Cancer
This is a multicenter, Phase 1b/2 trial in participants with estrogen receptor positive/human epidermal growth factor receptor 2 negative (ER+/HER2-) advanced/metastatic breast cancer.
- Trial name
- ELEVATE (NCT05563220)
- Testing
- Elacestrant, Alpelisib, Everolimus
- Where
- 83 sites in United States, Argentina and 11 more
- Volunteers
- 435 people
- Sponsor
- Stemline Therapeutics, Inc.
Breast Neoplasms, Colorectal Neoplasms
A Study of LY4257496 in Participants With Cancer (OMNIRAY)
The main purpose of this study is to evaluate safety, tolerability, and efficacy of LY4257496 alone and as part of relevant standard of care (SOC) combination therapy in participants with Gastrin-releasing Peptide Receptor…
- Conditions
- Breast Neoplasms, Colorectal Neoplasms, Prostate Neoplasm, Endometrial Neoplasms
- Trial name
- OMNIRAY (NCT07114601)
- Testing
- LY4257496, Standard of Care Anticancer Therapies, LY4257529
- Where
- 33 sites in United States, Canada and 5 more
- Volunteers
- 421 people
- Sponsor
- Eli Lilly and Company
HR+/HER2- Breast Cancer
BGB-43395 Plus Letrozole Versus CDK4/6i Plus Letrozole for Patients With Advanced or Metastatic HR+/HER2- Breast Cancer Who Have Not Received Prior Treatment for Advanced or Metastatic Disease
The purpose of this study is to investigate the efficacy and safety of BGB-43395 in combination with letrozole compared with investigator's choice of cyclin-dependent kinase 4/6 inhibitor (CDK4/6i) in combination with letrozole…
- Trial name
- KANDELA-302 (NCT07492641)
- Testing
- BGB-43395, Letrozole, Abemaciclib
- Where
- 241 sites in United States, Australia and 14 more
- Volunteers
- 1,056 people
- Sponsor
- BeOne Medicines
Prostatic Neoplasms, Neoplasm Metastasis
A Study of Abemaciclib (LY2835219) With Abiraterone in Men With Prostate Cancer That Has Spread to Other Parts of the Body and is Expected to Respond to Hormonal Treatment (Metastatic Hormone-Sensitive Prostate Cancer)
The purpose of this study is to learn whether adding abemaciclib to abiraterone plus prednisone prolongs the time before prostate cancer gets worse. Participation may last approximately 60 months.
- Conditions
- Prostatic Neoplasms, Neoplasm Metastasis, Urogenital Neoplasms, Physiological Effects of Drugs
- Trial name
- CYCLONE 3 (NCT05288166)
- Testing
- Abemaciclib, Abiraterone, Prednisone or Prednisolone
- Where
- 266 sites in United States, Argentina and 22 more
- Volunteers
- 925 people
- Sponsor
- Eli Lilly and Company
Breast Neoplasms
A Study of Abemaciclib (LY2835219) Plus Hormone Therapy in Participants With Early Breast Cancer
The main purpose of this study is to measure how well abemaciclib works in participants with early breast cancer who are taking hormone therapy after surgery.
- Trial name
- eMonarcHER (NCT04752332)
- Testing
- Abemaciclib, Standard Adjuvant ET
- Where
- 115 sites in United States, Argentina and 18 more
- Volunteers
- 111 people
- Sponsor
- Eli Lilly and Company
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 Neoplasms, Neoplasm Metastasis
A Study of Tersolisib (LY4064809/STX-478) With Other Anti-Cancer Treatments in Participants With Advanced Breast Cancer With a Genetic Change (PIK3CA)
The purpose of the study is to assess the efficacy and safety of the addition of Tersolisib (LY4064809/STX-478) to other anti-cancer drugs as first treatment for advanced hormone receptor-positive (HR+)/human epidermal growth…
- Trial name
- NCT07174336
- Testing
- LY4064809, Ribociclib, Palbociclib
- Where
- 363 sites in United States, Argentina and 17 more
- Volunteers
- 800 people
- Sponsor
- Eli Lilly and Company
Metastatic Breast Cancer
Evaluation of Lasofoxifene Combined With Abemaciclib in Advanced or Metastatic ER+/HER2- Breast Cancer With an ESR1 Mutation
This is an open-label, multicenter, single-arm safety study evaluating the safety and tolerability of the lasofoxifene and abemaciclib combination for the treatment of pre- and postmenopausal women with locally advanced or…
- Trial name
- ELAINEII (NCT04432454)
- Testing
- Lasofoxifene and abemaciclib (VERZENIO (R)).
- Where
- 16 sites in United States
- Volunteers
- 29 people
- Sponsor
- Sermonix Pharmaceuticals Inc.
Healthy Volunteers
A Study of Abemaciclib (LY2835219) in Healthy Participants
The main purpose of this study is to compare different forms of abemaciclib (LY2835219) to see how much and how quickly each gets into the bloodstream after it is swallowed, and to check for any side effects.
- Trial name
- NCT07818967
- Testing
- Abemaciclib Tablet (Test Formulation), Abemaciclib Tablet (Reference Formulation), Abemaciclib Oral Granules (Test Formulation)
- Where
- Singapore
- Volunteers
- 15 people, healthy volunteers welcome
- Sponsor
- Eli Lilly and Company
Advanced Solid Tumor, HR+/HER2- Breast Cancer
Study of AVZO-021 in Patients With Advanced Solid Tumors
This study, the first clinical trial of AVZO-021, aims to determine the safety, tolerability, pharmacokinetics, pharmacodynamics, maximum tolerated dose, and anti-tumor effects of AVZO-021 in patients with advanced solid tumors.
- Conditions
- Advanced Solid Tumor, HR+/HER2- Breast Cancer, HR+, HER2-, Advanced Breast Cancer, CCNE1 Amplification
- Trial name
- NCT05867251
- Testing
- AVZO-021, Palbociclib, Fulvestrant
- Where
- 13 sites in United States, Australia
- Volunteers
- 430 people
- Sponsor
- Avenzo Therapeutics, Inc.
Metastatic Breast Cancer
A Study Evaluating the Efficacy and Safety of Multiple Treatment Combinations in Patients With Metastatic or Locally Advanced Breast Cancer
This is an umbrella study evaluating the efficacy and safety of multiple treatment combinations in participants with metastatic or inoperable locally advanced breast cancer. The study will be performed in two stages.
- Trial name
- Morpheus-panBC (NCT03424005)
- Testing
- Capecitabine, Atezolizumab, Ipatasertib
- Where
- 55 sites in United States, Australia and 7 more
- Volunteers
- 1,132 people
- Sponsor
- Hoffmann-La Roche
Advanced Breast Cancer
A Phase Ib/II Study of QLC1401 Combined With CDK4/6 or mTOR Inhibitors in ER+/HER2- Advanced Breast Cancer
This study is an open-label, multicenter, Phase Ib/II clinical trial designed to evaluate the safety, tolerability, efficacy, and pharmacokinetic characteristics of QLC1401 tablets in combination with CDK4/6 inhibitors or mTOR…
- Trial name
- NCT07173556
- Testing
- QLC1401
- Volunteers
- 96 people
- Sponsor
- Qilu Pharmaceutical Co., Ltd.
Relapsed Solid Tumor, Refractory Solid Tumor
A Study of Abemaciclib (LY2835219) in Combination With Other Anti-Cancer Treatments in Children and Young Adult Participants With Solid Tumors, Including Neuroblastoma
The study's purpose is to see if the drug, abemaciclib, is safe and effective when given with other drugs to kill cancer cells. The study is open to children and young adults with solid tumors, including neuroblastoma, that did…
- Trial name
- NCT04238819
- Testing
- Abemaciclib, Irinotecan, Temozolomide
- Where
- 25 sites in United States, Australia and 6 more
- Volunteers
- 47 people
- Sponsor
- Eli Lilly and Company
Breast Cancer, Chemotherapy-induced Diarrhea
Probiotics for Abemaciclib-Induced Abdominal Discomfort.
This study aims to evaluate whether the addition of probiotics can help reduce abdominal discomfort (such as diarrhea) in breast cancer patients receiving Abemaciclib treatment.
- Trial name
- NCT07605728
- Where
- Taiwan
- Volunteers
- 80 people
- Sponsor
- Leeuwenhoek Laboratories Co. Ltd.
Metastatic Breast Cancer
Efficacy & Safety Evaluation of Enobosarm in Combo With Abemaciclib in Treatment of ER+HER2- Metastatic Breast Cancer
STAGE 1: To determine the safety of enobosarm 9 milligram (mg) once daily (QD) used in combination with a CDK 4/6 inhibitor [Verzenio® (abemaciclib) tablets, for oral use, 150 mg twice daily (BID)].
- Trial name
- VERU-024 (NCT05065411)
- Testing
- Enobosarm & Abemaciclib Combo, non-steroidal AI, or steroidal AI (exemestane with or without everolimus) or Fulvestrant
- Where
- 30 sites in United States
- Volunteers
- 5 people
- Sponsor
- Veru Inc.
Breast Cancer
A Study of LOXO-783 in Patients With Breast Cancer/Other Solid Tumors
The main purpose of this study is to learn more about the safety, side effects, and effectiveness of LOXO-783. LOXO-783 may be used to treat breast cancer and other solid tumors that have a change in a particular gene (known as…
- Trial name
- PIKASSO-01 (NCT05307705)
- Testing
- LOXO-783, Fulvestrant, Imlunestrant
- Where
- 50 sites in United States, Australia and 10 more
- Volunteers
- 260 people
- Sponsor
- Eli Lilly and Company
Advanced Cancer, Metastatic Melanoma
A Study of LY3214996 Administered Alone or in Combination With Other Agents in Participants With Advanced/Metastatic Cancer
The purpose of this study is to determine the safety of an extracellular signal regulated kinase (ERK1/2) inhibitor LY3214996 administered alone or in combination with other agents in participants with advanced cancer.
- Conditions
- Advanced Cancer, Metastatic Melanoma, Metastatic Non-small Cell Lung Cancer, Colorectal Cancer
- Trial name
- NCT02857270
- Testing
- LY3214996, Midazolam, Abemaciclib
- Where
- 13 sites in United States, Australia and 2 more
- Volunteers
- 210 people
- Sponsor
- Eli Lilly and Company
Breast Cancer
A Study of Nonsteroidal Aromatase Inhibitors Plus Abemaciclib (LY2835219) in Postmenopausal Women With Breast Cancer
The main purpose of this study is to evaluate how effective nonsteroidal aromatase inhibitors (NSAI) plus abemaciclib are in postmenopausal women with breast cancer.
- Trial name
- MONARCH 3 (NCT02246621)
- Testing
- Abemaciclib, Anastrozole, Letrozole
- Where
- 155 sites in United States, Australia and 20 more
- Volunteers
- 493 people
- Sponsor
- Eli Lilly and Company