Clinical trials: Abemaciclib
Breast Cancer
Phase Ib/II Trial of Abemaciclib and Elacestrant in Patients With Brain Metastasis Due to HR+/Her2- Breast Cancer
This is a multi-institutional, single arm, open label, Phase Ib/II study of abemaciclib in combination with elacestrant in patients with HR+/Her2- breast cancer metastatic to the brain.
- Trial name
- NCT04791384
- Testing
- Abemaciclib, Elacestrant
- Where
- 4 sites in United States
- Volunteers
- 5 people
- Sponsor
- Criterium, Inc.
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
Advanced Cancer, Metastatic Cancer
A Study of Abemaciclib (LY2835219) in Native Chinese Participants With Advanced and/or Metastatic Cancers
The purpose of this study is to determine the safety of the study drug known as abemaciclib in native Chinese participants with advanced and/or metastatic cancers.
- Trial name
- NCT02919696
- Testing
- Abemaciclib
- Where
- 3 sites in China
- Volunteers
- 26 people
- Sponsor
- Eli Lilly and Company
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
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
Metastatic Breast Cancer, Advanced Breast Cancer
Implementing Patients´ Competence in Oral Breast Cancer Therapy
The aim of the IMPACT - Implementing Patients' competence in oral breast cancer therapy - study is to evaluate the effectiveness of a standardized patient education and coaching and optional eMBSR for therapy management provided…
- Trial name
- IMPACT (NCT04030728)
- Volunteers
- 212 people
- Sponsor
- Onco Medical Consult GmbH
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.
Breast Cancer
Endocrine Therapy With or Without Abemaciclib (LY2835219) Following Surgery in Participants With Breast Cancer
The purpose of this study is to evaluate the safety and efficacy of the study drug abemaciclib in participants with high risk, node positive, early stage, hormone receptor positive (HR+), human epidermal receptor 2 negative…
- Trial name
- monarchE (NCT03155997)
- Testing
- Abemaciclib, Standard Adjuvant Endocrine Therapy
- Where
- 619 sites in United States, Argentina and 36 more
- Volunteers
- 5,637 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 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
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
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.
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, Hormone Receptor Positive Tumor
A Neoadjuvant Study of Abemaciclib (LY2835219) in Postmenopausal Women With Hormone Receptor Positive, HER2 Negative Breast Cancer
The purpose of this study is to evaluate the biological effects of abemaciclib in combination with anastrozole and compare those to the effects of abemaciclib alone and anastrozole alone in the tumors of postmenopausal women with…
- Conditions
- Breast Cancer, Hormone Receptor Positive Tumor, Early-Stage Breast Carcinoma
- Trial name
- neoMONARCH (NCT02441946)
- Testing
- Abemaciclib, Loperamide, Anastrozole
- Where
- 66 sites in United States, Austria and 8 more
- Volunteers
- 224 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
Breast Cancer, Solid Tumors, Adult
First-in-Human Study of Tersolisib (STX-478) as Monotherapy and in Combination With Other Antineoplastic Agents in Participants With Advanced Solid Tumors
Study STX-478-101 (LY4064809) is a multipart, open-label, phase 1/2 study evaluating the safety, tolerability, pharmacokinetics (PK), and preliminary antitumor activity of STX-478 (LY4064809) in participants with advanced solid…
- Trial name
- PIKALO-1 (NCT05768139)
- Testing
- STX-478, Fulvestrant, Ribociclib
- Where
- 65 sites in United States, Belgium and 7 more
- Volunteers
- 880 people
- Sponsor
- Eli Lilly and Company
Breast Neoplasms, Brain Neoplasms
Study of Abemaciclib and Elacestrant in Participants With Brain Metastasis Due to ER+/HER-2- Breast Cancer
This is a multi-site, global, open-label study that includes a phase 1b evaluation of elacestrant in combination with abemaciclib in women and men with brain metastases from estrogen receptor (ER)-positive, human epidermal growth…
- Conditions
- Breast Neoplasms, Brain Neoplasms, Neoplasms by Site, Neoplasms
- Trial name
- ELECTRA (NCT05386108)
- Testing
- Elacestrant, Abemaciclib
- Where
- 86 sites in United States, Belgium and 8 more
- Volunteers
- 73 people
- Sponsor
- Stemline Therapeutics, Inc.
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.
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
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