A Study of Abemaciclib (LY2835219) in Participants With Breast Cancer, Non-small Cell Lung Cancer, or Melanoma That Has Spread to the Brain

Completed · Phase 2

Conditions studied: Breast Cancer, Non-small Cell Lung Cancer, Melanoma, Brain Metastases

In brief

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.

Key facts

Study ID: NCT02308020
Run by: Eli Lilly and Company
People needed: 162
Starts: 2015-04-20
Expected to finish: 2019-11-08
Last updated by the study team: 2020-12-19

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

Have brain metastases secondary to hormone receptor positive breast cancer, NSCLC, or melanoma.
Have either human epidermal growth factor receptor 2 positive (HER2+) (Study Part A) or negative HER2- (Study Part B) breast cancer.
Participants in Study Part C must have HR+ breast cancer, NSCLC, or melanoma with brain lesions clinically indicated for surgical resection as well as consent to provide tissue for drug concentration determination after 5 to 14 days of study drug dosing.
Participants in Part D must have NSCLC of any subtype.
Participants in Part E must have melanoma of any subtype.
Participants in Part F must have HR+ breast cancer, NSCLC, or melanoma with leptomeningeal metastases.
For Parts A, B, D, and E: Must have at least 1 measurable brain lesion ≥10 millimeters (mm) in the longest diameter (LD).
For Part C (surgical): Have metastatic brain lesion(s) for which surgical resection is clinically indicated.
Have completed local therapy (surgical resection, whole-breast radiotherapy (WBRT), or SRS) ≥14 days prior to initiating abemaciclib and recovered from all acute effects.
If receiving concomitant corticosteroids, must be on a stable or decreasing dose for at least 7 days prior to the baseline Gd-MRI.
Have a Karnofsky performance status of ≥70.
Have a life expectancy ≥12 weeks.
For HR+ breast cancer participants in part A, B, C, and F: If currently receiving endocrine therapy, a participant may continue to receive the same endocrine therapy provided that extracranial disease is stable for at least 3 months and central nervous system (CNS) disease progression has occurred while on this endocrine therapy. If these conditions are not met, participants must discontinue endocrine therapy prior to initiation of abemaciclib.
For HER2+ breast cancer participants in parts A, C, and F: participants may receive concurrent treatment (ongoing or initiated simultaneously with abemaciclib) with IV trastuzumab.
For NSCLC participants in parts C, D, and F: if currently receiving gemcitabine or pemetrexed (single-agent or in combination with another therapy), a participant may continue to receive 1 of these 2 therapies provided that extracranial disease is stable for at least 6 weeks and CNS disease progression has occurred while on this therapy.
Have adequate organ function.

You may not qualify if…

Require immediate local therapy, including but not limited to WBRT, SRS, or surgical resection, for treatment of brain metastases.
Are taking concurrent enzyme-inducing antiepileptic drugs (EIAED).
Have evidence of significant (ie, symptomatic) intracranial hemorrhage.
For Parts A, B, C, D, E: Have evidence of leptomeningeal metastases. Note: discrete dural metastases are permitted.
Have experienced >2 seizures within 4 weeks prior to study entry.
For Parts A, B, D, E, and F: Have previously received treatment with any cyclin dependent kinase 6 (CDK6) inhibitor. For Part C participants may have received prior palbociclib or ribociclib, but not abemaciclib treatment.
Have known contraindication to Gd-MRI.
Have a preexisting chronic condition resulting in persistent diarrhea.

Where it is running

City of Hope National Medical Center — Duarte, California, United States
University of California - San Diego — La Jolla, California, United States
Univ of California San Francisco — San Francisco, California, United States
John Wayne Cancer Institute — Santa Monica, California, United States
University of Colorado — Aurora, Colorado, United States
Georgetown University Medical Center — Washington D.C., District of Columbia, United States
Florida Cancer Specialists — Fort Myers, Florida, United States
H Lee Moffitt Cancer Center — Tampa, Florida, United States
Kaiser Permanente Center for Health Research — Honolulu, Hawaii, United States
James Graham Brown Cancer Center — Louisville, Kentucky, United States
Dana Farber Cancer Institute — Boston, Massachusetts, United States
University of Michigan — Ann Arbor, Michigan, United States
Washington University Medical Center — St Louis, Missouri, United States
Memorial Sloan Kettering Cancer Center — New York, New York, United States
University of North Carolina at Chapel Hill — Chapel Hill, North Carolina, United States
Providence Health and Services — Portland, Oregon, United States
SMO Sarah Cannon Research Inst. — Nashville, Tennessee, United States
Tennessee Oncology PLLC — Nashville, Tennessee, United States
University of Texas MD Anderson Cancer Center — Houston, Texas, United States
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. — Nedlands, Australia
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. — Newcastle, Australia
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. — Southport, Australia
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. — Woolloongabba, Australia
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. — Vienna, Austria
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. — Brussels, Belgium

Full record on ClinicalTrials.gov

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