A Phase 2 Study of Abemaciclib in Patients With Brain Metastases Secondary to Hormone Receptor Positive Breast Cancer, Non-small Cell Lung Cancer, or Melanoma

The main purpose of this study is to evaluate the safety and effectiveness of the study drug known as abemaciclib in participants with hormone receptor positive breast cancer, non-small cell lung cancer (NSCLC), or melanoma that has spread to the brain.

Inclusion Criteria:

* Women with brain metastases secondary to hormone receptor positive breast cancer.

* Have either human epidermal growth factor receptor 2 positive (HER2+) disease (Study Part A) or HER2- disease (Study Part B). Participants in Study Part C may have either HER2+ or HER2- disease, and must have brain lesions clinically indicated for surgical resection as well as provide consent to provide tissue for drug concentration determination after 5 to 14 days of study drug dosing.

* For Parts A & B: Must have at least 1 new or not previously irradiated measurable metastatic brain lesion ≥10 millimeters (mm) in the longest diameter (LD) or a progressive previously irradiated metastatic brain lesion on radiographic imaging by gadolinium-enhanced magnetic resonance imaging (Gd MRI). Note: for participants with prior whole brain radiotherapy (WBRT) or stereotactic radiosurgery (SRS), previously irradiated lesion(s) must demonstrate unequivocal progression on baseline Gd-MRI in the opinion of the investigator. Otherwise new or not previously irradiated lesions must be present. For Part C (surgical): Have 1 to 3 metastatic brain lesion(s) for which surgical resection is clinically indicated.

* Have completed local therapy (surgical resection, WBRT, or SRS) ≥14 days prior to initiating abemaciclib and recovered from all acute effects. Participants are not required to have received prior local therapy for study participation.

* If receiving concomitant corticosteroids, must be on a stable or decreasing dose for at least 7 days prior to the baseline Gd-MRI.
Phase II
Cancer, All Other
Alison Conlin, M.D.
Eli Lilly and Company
Nikki Moxon
  • Oncology and Hematology Care Eastside
  • Oncology and Hematology Care Westside