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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

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ClinicalTrials.gov Identifier: NCT02308020
Recruitment Status : Recruiting
First Posted : December 4, 2014
Last Update Posted : November 6, 2017
Sponsor:
Information provided by (Responsible Party):

December 2, 2014
December 4, 2014
November 6, 2017
April 2015
October 2018   (Final data collection date for primary outcome measure)
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) ]
Same as current
Complete list of historical versions of study NCT02308020 on ClinicalTrials.gov Archive Site
  • 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) ]
Same as current
Not Provided
Not Provided
 
A Study of Abemaciclib (LY2835219) in Participants With Breast Cancer, Non-small Cell Lung Cancer, or Melanoma That Has Spread to the Brain
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.
Not Provided
Interventional
Phase 2
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
  • Breast Cancer
  • Non-small Cell Lung Cancer
  • Melanoma
  • Brain Metastases
Drug: Abemaciclib
Administered orally
Other Name: LY2835219
  • 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.

    Intervention: Drug: Abemaciclib
  • 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.

    Intervention: Drug: Abemaciclib
  • 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.

    Intervention: Drug: Abemaciclib
  • 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.

    Intervention: Drug: Abemaciclib
  • 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.

    Intervention: Drug: Abemaciclib
  • 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.

    Intervention: Drug: Abemaciclib
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
247
October 2018
October 2018   (Final data collection date for primary outcome measure)

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.
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact: There may be multiple sites in this clinical trial. 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559
Australia,   Austria,   Belgium,   Canada,   France,   Israel,   Italy,   New Zealand,   Spain,   United States
 
 
NCT02308020
15450
I3Y-MC-JPBO ( Other Identifier: Eli Lilly and Company )
2014-004010-28 ( EudraCT Number )
No
Not Provided
Not Provided
Eli Lilly and Company
Eli Lilly and Company
Not Provided
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
Eli Lilly and Company
November 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP