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

This study is currently recruiting participants.
Verified November 2017 by Eli Lilly and Company
Sponsor:
ClinicalTrials.gov Identifier:
NCT02308020
First Posted: December 4, 2014
Last Update Posted: November 6, 2017
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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Information provided by (Responsible Party):
Eli Lilly and Company
  Purpose
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.

Condition Intervention Phase
Breast Cancer Non-small Cell Lung Cancer Melanoma Brain Metastases Drug: Abemaciclib Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:


Further study details as provided by Eli Lilly and Company:

Primary Outcome Measures:
  • Percentage of Participants Achieving Complete Response (CR) or Partial Response (PR): Objective Intracranial Response Rate (OIRR) [ Time Frame: Baseline to Objective Disease Progression (Approximately 6 Months) ]

Secondary Outcome Measures:
  • Percentage of Participants with CR, PR, Stable Disease (SD), Progressive Disease (PD), or Not Evaluable (NE): Best Overall Intracranial Response (BOIR) [ Time Frame: Baseline to Earliest Objective Progression or Start of New Anticancer Therapy (Approximately 6 Months) ]
  • Duration of CR and PR: Duration of Intracranial Response (DOIR) [ Time Frame: Date of Complete Response or Partial Response to Date of Objective Disease Progression or Death from Any Cause (Approximately 6 Months) ]
  • Proportion of Participants with BOIR of CR, PR, or SD: Intracranial Disease Control Rate (IDCR) [ Time Frame: Baseline to Disease Progression or Start of New Anticancer Therapy (Approximately 6 Months) ]
  • Proportion of Participants with BOIR of CR, PR, or SD with Duration of SD for at Least 6 Months: Intracranial Clinical Benefit Rate (ICBR) [ Time Frame: Baseline to Disease Progression or Start of New Anticancer Therapy (Approximately 6 Months) ]
  • Overall Survival [ Time Frame: Baseline to Death from Any Cause (Approximately 18 Months) ]
  • Percentage of Participants with a Best Response of CR or PR: Objective Response Rate (ORR) [ Time Frame: Baseline to Disease Progression (Approximately 6 Months) ]
  • Proportion of Participants with a Best Overall Response of CR, PR, or SD: Disease Control Rate (DCR) [ Time Frame: Baseline to Disease Progression or Start of New Anticancer Therapy (Approximately 6 Months) ]
  • Progression Free Survival [ Time Frame: Baseline to Objective Disease Progression or Death from Any Cause (Approximately 6 Months) ]
  • Change from Baseline to End of Study in Neurologic Symptoms on the MD Anderson Symptom Inventory-Brain Tumor (MDASI-BT) Scale [ Time Frame: Baseline, End of Study (Approximately 6 Months) ]
  • Pharmacokinetics (PK): Minimum Concentration (Cmin) of Abemaciclib and its Metabolites [ Time Frame: Cycle 1 through Cycle 4 (Approximately 3 Months) ]

Estimated Enrollment: 247
Study Start Date: April 2015
Estimated Study Completion Date: October 2018
Estimated Primary Completion Date: October 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Part A: HER2+ Breast Cancer

Participants with HR+, HER2+ breast cancer.

200 milligrams (mg) abemaciclib given orally once every 12 hours on days 1-21 of a 21 day cycle. Participants may continue to receive treatment until discontinuation criteria are met.

Drug: Abemaciclib
Administered orally
Other Name: LY2835219
Experimental: Part B: HER2- Breast Cancer

Participants with HR+, HER2- breast cancer.

200 mg abemaciclib given orally once every 12 hours on days 1-21 of a 21 day cycle. Participants may continue to receive treatment until discontinuation criteria are met.

Drug: Abemaciclib
Administered orally
Other Name: LY2835219
Experimental: Part C: Surgical Resection

Participants with HR+ breast cancer, NSCLC, or melanoma with intracranial lesions for which surgical resection is clinically indicated.

200 mg abemaciclib given orally once every 12 hours for 5-14 days prior to surgical resection. Dosing may resume following wound healing on a 21 day cycle. Participants may continue to receive treatment until discontinuation criteria are met.

Drug: Abemaciclib
Administered orally
Other Name: LY2835219
Experimental: Part D: NSCLC

Participants with NSCLC.

200 milligrams mg (150 mg for participants receiving concurrent gemcitabine or pemetrexed) abemaciclib given orally once every 12 hours on days 1-21 of a 21 day cycle. Participants may continue to receive treatment until discontinuation criteria are met.

Drug: Abemaciclib
Administered orally
Other Name: LY2835219
Experimental: Part E: Melanoma

Participants with melanoma.

200 milligrams mg abemaciclib given orally once every 12 hours on days 1-21 of a 21 day cycle. Participants may continue to receive treatment until discontinuation criteria are met.

Drug: Abemaciclib
Administered orally
Other Name: LY2835219
Experimental: Part F: HR+ Breast Cancer, NSCLC, or Melanoma

Participants with HR+ breast cancer, NSCLC, or melanoma and leptomeningeal metastases.

200 milligrams mg abemaciclib given orally once every 12 hours on days 1-21 of a 21 day cycle. Participants may continue to receive treatment until discontinuation criteria are met.

Drug: Abemaciclib
Administered orally
Other Name: LY2835219

  Eligibility

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.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
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): NCT02308020


Contacts
Contact: There may be multiple sites in this clinical trial. 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559

  Show 55 Study Locations
Sponsors and Collaborators
Eli Lilly and Company
Investigators
Study Director: Call 1-877-CTLILLY (1-877-285-459) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST) Eli Lilly and Company
  More Information

Additional Information:
Responsible Party: Eli Lilly and Company
ClinicalTrials.gov Identifier: NCT02308020     History of Changes
Other Study ID Numbers: 15450
I3Y-MC-JPBO ( Other Identifier: Eli Lilly and Company )
2014-004010-28 ( EudraCT Number )
First Submitted: December 2, 2014
First Posted: December 4, 2014
Last Update Posted: November 6, 2017
Last Verified: November 2017

Additional relevant MeSH terms:
Breast Neoplasms
Lung Neoplasms
Carcinoma, Non-Small-Cell Lung
Melanoma
Neoplasm Metastasis
Brain Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Respiratory Tract Neoplasms
Thoracic Neoplasms
Lung Diseases
Respiratory Tract Diseases
Carcinoma, Bronchogenic
Bronchial Neoplasms
Neuroendocrine Tumors
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms, Nerve Tissue
Nevi and Melanomas
Neoplastic Processes
Pathologic Processes
Central Nervous System Neoplasms
Nervous System Neoplasms
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases