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
- Study Details
- Tabular View
- How to Read a Study Record
|Condition or disease||Intervention/treatment|
|Metastatic Breast Cancer||Drug: Abemaciclib|
|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|
- Drug: Abemaciclib
Administered orallyOther Name: LY2835219
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.
|Ages Eligible for Study:||18 Years and older (Adult, Older Adult)|
|Sexes Eligible for Study:||All|
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.
- 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.
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
|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|
|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|
|Study Director:||Contact Lilly at 1-800-LillyRx (1-800-545-5979)||Eli Lilly and Company|
|Responsible Party:||Eli Lilly and Company|
|Other Study ID Numbers:||
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|
Neoplasms by Site