Clinical Trial Details
Braintumor Website

[Information provided by: ClinicalTrials.gov, which provides patients, family members, and members of the public easy and free access to information on clinical studies for a wide range of diseases and conditions.]

NCT02308020 : A Study of Abemaciclib (LY2835219) in Participants With Breast Cancer, Non-small Cell Lung Cancer, or Melanoma That Has Spread to the Brain
PhasePhase 2
AgesMin: 18 Years Max: N/A
Eligibility
Inclusion Criteria:

- 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 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, 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.

Exclusion Criteria:

- 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.
LinksPermanent Link to THIS page: http://virtualtrials.com/nct/display1trial.cfm?nct=NCT02308020      |      Link to official Clinicaltrials.gov listing
Locations
Nedlands,
Australia

Facility: 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.
Investigator:
Contact: Eli Lilly and Company
Email not avaialable

Newcastle,
Australia

Facility: 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.
Investigator:
Contact: Eli Lilly and Company
Email not avaialable

Southport,
Australia

Facility: 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.
Investigator:
Contact: Eli Lilly and Company
Email not avaialable

Woolloongabba,
Australia

Facility: 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.
Investigator:
Contact: Eli Lilly and Company
Email not avaialable

Wien,
Austria

Facility: 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.
Investigator:
Contact: Eli Lilly and Company
Email not avaialable

Brussel,
Belgium

Facility: 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.
Investigator:
Contact: Eli Lilly and Company
Email not avaialable

Charleroi,
Belgium

Facility: 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.
Investigator:
Contact: Eli Lilly and Company
Email not avaialable

Leuven,
Belgium

Facility: 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.
Investigator:
Contact: Eli Lilly and Company
Email not avaialable

Liege,
Belgium

Facility: 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.
Investigator:
Contact: Eli Lilly and Company
Email not avaialable

Montreal,
Canada

Facility: For additional information regarding investigative sites for this trial, contact 1-888-545-5972 Mon - Fri, 9 AM to 4 PM or 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri, 9 AM to 5 PM Eastern Time or speak with your personal physician.
Investigator:
Contact: Eli Lilly and Company
Email not avaialable

Ottawa,
Canada

Facility: For additional information regarding investigative sites for this trial, contact 1-888-545-5972 Mon - Fri, 9 AM to 4 PM or 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri, 9 AM to 5 PM Eastern Time or speak with your personal physician.
Investigator:
Contact: Eli Lilly and Company
Email not avaialable

Lille,
France

Facility: 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.
Investigator:
Contact: Eli Lilly and Company
Email not avaialable

Lille Cedex,
France

Facility: 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.
Investigator:
Contact: Eli Lilly and Company
Email not avaialable

Lyon Cedex 08,
France

Facility: 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.
Investigator:
Contact: Eli Lilly and Company
Email not avaialable

Montpellier,
France

Facility: For additional information regarding investigative sites for this trial, contact 1-888-545-5972 Mon - Fri, 9 AM to 4 PM or 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri, 9 AM to 5 PM Eastern Time or speak with your personal physician.
Investigator:
Contact: Eli Lilly and Company
Email not avaialable

Paris Cedex 05,
France

Facility: 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.
Investigator:
Contact: Eli Lilly and Company
Email not avaialable

Saint-Brieuc,
France

Facility: 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.
Investigator:
Contact: Eli Lilly and Company
Email not avaialable

Toulouse cedex 9,
France

Facility: 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.
Investigator:
Contact: Eli Lilly and Company
Email not avaialable

Jerusalem,
Israel

Facility: Hadassah Medical Center - Ein Karem
Investigator: Luna Kadouri Sonenfeld
Contact: Phone: 972-2-6777914
Email not avaialable

Tel Aviv Jaffa,
Israel

Facility: 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.
Investigator:
Contact: Eli Lilly and Company
Email not avaialable

Tel Hashomer,
Israel

Facility: Sheba Medical Center
Investigator: Jacob Schachter
Contact: Phone: 972-3-5302243
Email not avaialable

Cona,
Italy

Facility: "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."
Investigator:
Contact: Eli Lilly and Company
Email not avaialable

Genova,
Italy

Facility: 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.
Investigator:
Contact: Eli Lilly and Company
Email not avaialable

Padova,
Italy

Facility: 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.
Investigator:
Contact: Eli Lilly and Company
Email not avaialable

Roma,
Italy

Facility: 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.
Investigator:
Contact: Eli Lilly and Company
Email not avaialable

Grafton,
New Zealand

Facility: 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.
Investigator:
Contact: Eli Lilly and Company
Email not avaialable

Barcelona,
Spain

Facility: 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.
Investigator:
Contact: Eli Lilly and Company
Email not avaialable

Madrid,
Spain

Facility: 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.
Investigator:
Contact: Eli Lilly and Company
Email not avaialable

Sevilla,
Spain

Facility: 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.
Investigator:
Contact: Eli Lilly and Company
Email not avaialable

Duarte, California
Facility: City of Hope National Medical Center
Investigator: Jana Portnow
Contact: Phone: 626-256-4673
Email not avaialable

La Jolla, California
Facility: University of California - San Diego
Investigator: David Piccioni
Contact:
Email not avaialable

San Francisco, California
Facility: Univ of California San Francisco
Investigator: Michelle Melisko
Contact: Phone: 415-885-3732
Email not avaialable

Aurora, Colorado
Facility: University of Colorado
Investigator: Peter Kabos
Contact: Phone: 720-848-1030
Email not avaialable

Washington, District of Columbia
Facility: Georgetown University Medical Center
Investigator: Deepa Subramaniam
Contact: Phone: 202-444-2198
Email not avaialable

Fort Myers, Florida
Facility: Florida Cancer Specialists
Investigator: Lowell Hart
Contact: Phone: 239-275-6400
Email not avaialable

Tampa, Florida
Facility: H Lee Moffitt Cancer Center
Investigator: Solmaz Sahebjam
Contact: Phone: 813-745-3871
Email not avaialable

Honolulu, Hawaii
Facility: Kaiser Permanente Center for Health Research
Investigator: Jennifer Carney
Contact: Phone: 808-432-8587
Email not avaialable

Louisville, Kentucky
Facility: James Graham Brown Cancer Center
Investigator: Goetz Kloecker
Contact: Phone: 502-562-4246
Email not avaialable

Boston, Massachusetts
Facility: Dana Farber Cancer Institute
Investigator: Sara Tolaney
Contact: Phone: 617-632-3800
Email not avaialable

Ann Arbor, Michigan
Facility: University of Michigan
Investigator: Aki Morikawa
Contact: Phone: 734-764-1817
Email not avaialable

Saint Louis, Missouri
Facility: Washington University Medical Center
Investigator: Michael Naughton
Contact: Phone: 314-996-8270
Email not avaialable

Albuquerque, New Mexico
Facility: University of New Mexico Cancer Center
Investigator: Olivier Rixe
Contact: Phone: 505-925-0413
Email not avaialable

New York, New York
Facility: New York University Medical Center
Investigator: Francisco Esteva
Contact: Phone: 212-731-5657
Email not avaialable

New York, New York
Facility: Memorial Sloan Kettering Cancer Center
Investigator: Mariza Daras
Contact: Phone: 212-639-3709
Email not avaialable

Stony Brook, New York
Facility: SUNY At Stony Brook
Investigator: Roger Keresztes
Contact: Phone: 631-444-2296
Email not avaialable

Stony Brook, New York
Facility: SUNY At Stony Brook
Investigator: Roger Keresztes
Contact: Phone: 631-444-2296
Email not avaialable

Chapel Hill, North Carolina
Facility: University of North Carolina at Chapel Hill
Investigator: Carey Anders
Contact: Phone: 919-966-4431
Email not avaialable

Portland, Oregon
Facility: Providence Health and Services
Investigator: Alison Conlin
Contact: Phone: 506-216-8636
Email not avaialable

Nashville, Tennessee
Facility: SMO Sarah Cannon Research Inst.
Investigator: Sarah Cannon Research Inst.
Contact: Phone: 615-329-7615
Email not avaialable

Nashville, Tennessee
Facility: Tennessee Oncology PLLC
Investigator: Denise Yardley
Contact: Phone: 615-340-2827
Email not avaialable

Houston, Texas
Facility: University of Texas MD Anderson Cancer Center
Investigator: Siqing Fu
Contact: Phone: 713-792-9669
Email not avaialable

Charlottesville, Virginia
Facility: University of Virginia Health System
Investigator: Patrick Dillon
Contact: Phone: 434-924-8073
Email not avaialable




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