Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Expanded Access Program to Provide Abemaciclib (LY2835219) for the Treatment of Metastatic Breast Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02792725
Expanded Access Status : Approved for marketing
First Posted : June 7, 2016
Last Update Posted : October 31, 2017
Sponsor:
Information provided by (Responsible Party):
Eli Lilly and Company

Brief Summary:
The treating physician/investigator contacts Lilly when, based on their medical opinion, a patient meets the criteria for inclusion in the expanded access program.

Condition or disease Intervention/treatment
Metastatic Breast Cancer Drug: Abemaciclib

Layout table for study information
Study Type : Expanded Access
Official Title: An Open-Label, Multi-Center Expanded Access Program of Abemaciclib for the Treatment of Hormone Receptor Positive, HER2 Negative Advanced or Metastatic Breast Cancer in Patients With Disease Progression on Prior Therapies

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer
Drug Information available for: Abemaciclib


Intervention Details:
  • Drug: Abemaciclib
    Administered orally
    Other Name: LY2835219

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Criteria

Inclusion Criteria:

  • Have a diagnosis of hormone receptor positive (HR+), human epidermal growth factor receptor 2 negative (HER2-) breast cancer.

    • To fulfill the requirement of HR+ disease, a breast cancer must express, by immunohistochemistry, at least 1 of the hormone receptors (estrogen receptor or progesterone receptor).
    • To fulfill the requirement of HER2- disease, a breast cancer must not demonstrate, at initial diagnosis or upon subsequent biopsy, overexpression of HER2 by either immunohistochemistry or in-situ hybridization.
  • Have recurrent, locally advanced, unresectable or metastatic breast cancer with disease progression following anti-estrogen therapy.
  • Have a performance status of 0 to 2 on the Eastern Cooperative Oncology Group scale.
  • Have discontinued all previous therapies for cancer (including chemotherapy, radiotherapy, immunotherapy, and endocrine therapy) for at least 21 days for myelosuppressive agents or 14 days for nonmyelosuppressive agents prior to receiving abemaciclib, and recovered from the acute effects of therapy (until the toxicity resolves to either baseline or at least Grade 1) except for residual alopecia and peripheral neuropathy.
  • Have adequate organ function, including:

    • Hematologic: absolute neutrophil count ≥1.5 × 10⁹/Liter (L), platelets ≥100 × 10⁹/L, and hemoglobin ≥8 grams/deciliter. Participants may receive erythrocyte transfusions to achieve this hemoglobin level at the discretion of the treating physician. Initial treatment should not begin earlier than the day after the erythrocyte transfusion.
    • Hepatic: bilirubin ≤1.5 × the upper limit of normal (ULN) and alanine aminotransferase ≤3 × ULN.
    • Renal: serum creatinine ≤ULN.
  • If a woman of child-bearing potential, must test negative for pregnancy at the time of enrollment based on serum pregnancy test, and must agree to use a reliable method of birth control during the program and for 3 months following the last dose of the abemaciclib.
  • If a man, must agree to use a reliable method of birth control and to not donate sperm during the program and for at least 3 months following the last dose of abemaciclib (or country requirements, whichever is longer).
  • Are able to swallow capsules.

Exclusion Criteria:

  • Are currently enrolled in a clinical trial involving an investigational product or concurrently enrolled in any other type of medical research judged not to be scientifically or medically compatible with this program.
  • Have progressive central nervous system metastasis that require immediate local therapy including (but not limited to) whole-brain radiotherapy, stereotactic radiosurgery, surgical resection, or intrathecal chemotherapy.
  • Have a history of progressive disease during prior therapy with a cyclin-dependent kinase (CDK) 4&6 inhibitor.
  • Have had major surgery within 14 days of the initial dose of abemaciclib.
  • Have a personal history of any of the following conditions: syncope of either unexplained or cardiovascular etiology, ventricular tachycardia, ventricular fibrillation, or sudden cardiac arrest.
  • Have active bacterial, fungal, and/or known viral infection.
  • If lactating, must agree to not begin and/or discontinue breastfeeding.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02792725


Locations
Layout table for location information
United States, California
Pacific Cancer Care
Monterey, California, United States, 93940
UCLA Medical Center
Santa Monica, California, United States, 90404
United States, Florida
Orlando Health, Inc
Orlando, Florida, United States, 32806
United States, Illinois
Rush University Medical Center
Chicago, Illinois, United States, 60612
United States, Minnesota
Mayo Clinic
Rochester, Minnesota, United States, 55905
University of Minnesota Medical Center, Fairview Lakes
Wyoming, Minnesota, United States, 55092
United States, Missouri
Saint Luke's Cancer Institute
Kansas City, Missouri, United States, 64111
United States, New York
Memorial Sloan Kettering Cancer Center
Commack, New York, United States, 11725
United States, Texas
Texas Oncology-Baylor Charles A. Sammons Cancer Center
Dallas, Texas, United States, 75246
United States, West Virginia
West Virginia University Hospital
Morgantown, West Virginia, United States, 26506
Sponsors and Collaborators
Eli Lilly and Company
Investigators
Layout table for investigator information
Study Director: Contact Lilly at 1-800-LillyRx (1-800-545-5979) Eli Lilly and Company

Layout table for additonal information
Responsible Party: Eli Lilly and Company
ClinicalTrials.gov Identifier: NCT02792725     History of Changes
Other Study ID Numbers: 16244
I3Y-MC-JPCD ( Other Identifier: Eli Lilly and Company )
First Posted: June 7, 2016    Key Record Dates
Last Update Posted: October 31, 2017
Last Verified: October 2017
Additional relevant MeSH terms:
Layout table for MeSH terms
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases