A Study of Abemaciclib (LY2835219) With and Without Food in Participants With Metastatic Breast Cancer
NCT ID: NCT03703466
Last Updated: 2024-04-02
Study Results
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
PHASE2
72 participants
INTERVENTIONAL
2018-11-28
2023-03-09
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
A Study of Abemaciclib (LY2835219) In Participants With Previously Treated Breast Cancer That Has Spread
NCT02102490
Endocrine Therapy With or Without Abemaciclib (LY2835219) Following Surgery in Participants With Breast Cancer
NCT03155997
A Study of Abemaciclib (LY2835219) Plus Tamoxifen or Abemaciclib Alone in Women With Metastatic Breast Cancer
NCT02747004
A Study of Abemaciclib (LY2835219) in Participants With Breast Cancer, Non-small Cell Lung Cancer, or Melanoma That Has Spread to the Brain
NCT02308020
A Study of Abemaciclib (LY2835219) in Participants With HR+, HER2- Advanced Breast Cancer
NCT03988114
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
200 mg Abemaciclib With a Meal
200 mg abemaciclib given twice a day (BID) orally with a meal.
Abemaciclib
Administered orally.
200 mg Abemaciclib Without a Meal
200 mg abemaciclib given twice a day (BID) orally without a meal, taken in the modified fasted condition.
Abemaciclib
Administered orally.
200 mg Abemaciclib Without Regard to Food
200 mg abemaciclib given twice a day (BID) orally without regard for food.
Abemaciclib
Administered orally.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Abemaciclib
Administered orally.
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* Have all of the following:
* Recurrent, locally advanced, unresectable or mBC with disease progression following anti-estrogen therapy.
* Prior treatment with chemotherapy for locally advanced or metastatic disease.
* No prior treatment with cyclin-dependent kinases (CDK) 4 and 6 inhibitor.
* Have Eastern Cooperative Oncology Group performance status (ECOG PS) ≤1.
* Have discontinued all previous treatments for cancer and recovered from the acute effects of therapy.
* Have adequate organ function.
* Women of child-bearing potential must have a negative pregnancy test.
* Are able to swallow tablets/capsules.
Exclusion Criteria
* Have a serious concomitant systemic disorder.
* Have symptomatic central nervous system (CNS) malignancy or metastasis.
* Have a symptomatic Human Immunodeficiency Virus (HIV) infection or symptomatic activated/reactivated hepatitis A, B, or C.
* Have a personal history of syncope of either unexplained or cardiovascular etiology, ventricular tachycardia, ventricular fibrillation, or sudden cardiac arrest.
* Have a history of any other cancer.
* Had major surgery within 14 days prior to randomization.
* Are breastfeeding.
* Have received treatment with a drug that has not received regulatory approval for any indication within 14 or 21 days of the initial dose of study drug for a nonmyelosuppressive or myelosuppressive agent, respectively.
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Eli Lilly and Company
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)
Role: STUDY_DIRECTOR
Eli Lilly and Company
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Mater Private Hospital
North Sydney, New South Wales, Australia
St Vincent's Hospital
Sydney, New South Wales, Australia
Ashford Cancer Centre Research
Kurralta Park, South Australia, Australia
Peter MacCallum Cancer Centre
Melbourne, Victoria, Australia
Universitaire Ziekenhuizen Leuven - Campus Gasthuisberg
Leuven, , Belgium
Russian Oncological Research Center
Moscow, , Russia
Volgograd regional clinical oncology dispensary
Volgograd, , Russia
Hospital Quirón Salud Barcelona-Instituto Oncológico Baselga
Barcelona, , Spain
Hospital Universitari Vall d'Hebron
Barcelona, , Spain
Hospital Ruber Internacional
Madrid, , Spain
Hospital Clinico San Carlos
Madrid, , Spain
Akdeniz University Medical Faculty
Antalya, , Turkey (Türkiye)
Trakya University Faculty of Medicine
Edirne, , Turkey (Türkiye)
Medical Park Izmir Hospital
Izmir, , Turkey (Türkiye)
Inonu University Medical Faculty
Malatya, , Turkey (Türkiye)
Countries
Review the countries where the study has at least one active or historical site.
Provided Documents
Download supplemental materials such as informed consent forms, study protocols, or participant manuals.
Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Related Links
Access external resources that provide additional context or updates about the study.
A Study of Abemaciclib (LY2835219) With and Without Food in Participants With Metastatic Breast Cancer
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
I3Y-MC-JPCP
Identifier Type: OTHER
Identifier Source: secondary_id
2018-001853-28
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
17041
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.