A Study of Abemaciclib (LY2835219) in Participants With B... | NCT02308020 | Trialant
NCT02308020
Sponsor
Eli Lilly and Company
Status
Completed
Last Update Posted
Dec 19, 2020Actual
Enrollment
162Actual
Phase
Phase 2
Conditions
Breast Cancer
Non-small Cell Lung Cancer
Melanoma
Brain Metastases
Interventions
Abemaciclib
Countries
United States
Australia
Austria
Belgium
Canada
France
Israel
Italy
Spain
Protocol Section
Identification Module
NCT ID
NCT02308020
Obsolete or Duplicate NCT IDs
Not provided
Organization Study
15450
Secondary IDs
ID
Type
Description
Link
I3Y-MC-JPBO
Other Identifier
Eli Lilly and Company
2014-004010-28
EudraCT Number
Brief Title
A Study of Abemaciclib (LY2835219) in Participants With Breast Cancer, Non-small Cell Lung Cancer, or Melanoma That Has Spread to the Brain
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
Acronym
Not provided
Organization
Eli Lilly and CompanyINDUSTRY
Status Module
Record Verification Date
Dec 2020
Overall Recruitment Status or Expanded Access Status
Completed
Last Known Status
Not provided
Delayed Posting
Not provided
Why Stopped
Not provided
Expanded Access Info
YesNCT03763604Approved for marketing
Start Date
Apr 20, 2015Actual
Primary Completion Date
Nov 8, 2018Actual
Completion Date
Nov 8, 2019Actual
First Submitted Date
Dec 2, 2014
First Submission Date that Met QC Criteria
Dec 2, 2014
First Posted Date
Dec 4, 2014Estimated
Results Waived
Not provided
Results First Submitted Date
Nov 6, 2019
Results First Submitted that Met QC Criteria
Dec 17, 2019
Results First Posted Date
Dec 19, 2019Actual
Certification/Extension (aka Delayed Results) First Submitted Date
Not provided
Certification/Extension First Submitted that Passed QC Review
Not provided
Certification/Extension First Posted Date
Not provided
Last Update Submitted Date
Dec 17, 2020
Last Update Posted Date
Dec 19, 2020Actual
Sponsor/Collaborators Module
Responsible Party, by Official Title
Sponsor
Lead Sponsor
Eli Lilly and CompanyINDUSTRY
Collaborators
Not provided
Oversight Module
Has Data Monitoring Committee (DMC)
No
Is FDA Regulated Drug
Not provided
Is FDA Regulated Device
Not provided
Is Unapproved Device
Not provided
Pediatric Postmarket Surveillance of a Device Product
Not provided
Product Exported from US
Not provided
FDAAA801 Violation
Not provided
Description Module
Brief Summary
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.
Detailed Description
Not provided
Conditions Module
Conditions
Breast Cancer
Non-small Cell Lung Cancer
Melanoma
Brain Metastases
Keywords
Not provided
Design Module
Study Type
Interventional
Number of References to an Expanded Access Study
Not provided
Expanded Access Types
Not provided
Patient Registry
Not provided
Target Follow-Up Duration
Not provided
Phases
Phase 2
Interventional Study Design
Allocation
Biospecimen
No data available
No data is available for this block.
Enrollment
162Actual
Arms/Interventions Module
Arm Groups
Label
Type
Description
Intervention Names
Part A Abemaciclib: HR+, HER2+ Breast Cancer
Experimental
Abemaciclib 200 milligram (mg) was administered orally once every 12 hours on days 1-21 of a 21-day cycle when administered as a single agent or in combination with endocrine therapy (ET). Participants with hormone receptor positive (HR+), HER2+ breast cancer receiving concurrent trastuzumab, 150 mg abemaciclib was 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
Part B Abemaciclib: HR+, HER2- Breast Cancer
Experimental
Abemaciclib 200 mg was administered orally once every 12 hours on days 1-21 of a 21-day cycle when administered as a single agent or for participants in combination with endocrine therapy (ET).
Participants may continue to receive treatment until discontinuation criteria are met.
Drug: Abemaciclib
Part C Abemaciclib: Surgical Resection
Experimental
Abemaciclib 200 mg was administered orally once every 12 hours on days 1-21 of a 21-day cycle when administered as a single agent or for participants with breast cancer in combination with endocrine therapy (ET). Participants with HR+, HER2+ breast cancer, NSCLC, or melanoma with intracranial lesions for which surgical resection is clinically indicated receiving concurrent trastuzumab, gemcitabine, or pemetrexed, 150 mg abemaciclib was 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
Part D Abemaciclib: Non-Small Cell Lung Cancer (NSCLC)
Interventions
Name
Type
Description
Arm Group Labels
Other Names
Abemaciclib
Drug
Administered orally
Part A Abemaciclib: HR+, HER2+ Breast Cancer
Part B Abemaciclib: HR+, HER2- Breast Cancer
Part C Abemaciclib: Surgical Resection
Outcomes Module
Primary Outcomes
Measure
Description
Time Frame
Percentage of Participants Achieving Complete Response (CR) or Partial Response (PR): Objective Intracranial Response Rate (OIRR)
OIRR is the percentage of participants with a (CR) or (PR) based on the Response Assessment in Neuro-Oncology Brain Metastasis (RANO-BM) response criteria. CR is measurable target lesions, the disappearance of all central nervous system (CNS) target lesions for at least 4 weeks; no new lesions; no corticosteroids; stable or improved clinically. PR is at least a 30% decrease in the sum longest duration (LD) of CNS target lesions, taking as reference the baseline sum LD for at least 4 weeks; no new lesions; stable to decreased corticosteroid dose; stable or improved clinically. Nontarget lesions requires disappearance CNS non-target lesions and no new CNS lesions. Stable disease (SD) is less than (<)30% decrease relative to baseline but <20% increase in sum LD relative to nadir. Progressive disease (PD) is greater than or equal to (≥) 20% increase in sum LD relative to nadir and a relative increase of 20%, ≥1 lesion must increase by absolute value of ≥5 millimeter (mm).
Baseline to Objective Disease Progression (Up to 36 Months)
Secondary Outcomes
Measure
Description
Time Frame
Percentage of Participants With CR, PR, Stable Disease (SD), Progressive Disease (PD), or Not Evaluable (NE): Best Overall Intracranial Response (BOIR)
Percentage of Participants with BOIR was categorized as CR, PR, SD, PD or NE, as defined by RANO-BM, from baseline until the earliest of objective progression according to brain metastases response criteria or start of new anticancer therapy. CR is measurable target lesions, the disappearance of all CNS target lesions for at least 4 weeks; no new lesions; no corticosteroids; stable or improved clinically. PR is at least a 30% decrease in the sum LD of CNS target lesions, taking as reference the baseline sum LD for at least 4 weeks; no new lesions; stable to decreased corticosteroid dose; stable or improved clinically. SD is <30% decrease relative to baseline but <20% increase in sum LD relative to nadir. PD is greater than or equal to (≥) 20% increase in sum LD relative to nadir and a relative increase of 20%, ≥1 lesion must increase by absolute value of ≥5 mm. NE is absent (no abnormality; normal), or non-evaluable (NE).
Other Outcomes
Not provided
Eligibility Module
Eligibility 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 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.
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.
Accepts Healthy Volunteers
No
Sex
All
Sex/Gender Based
Not provided
Sex/Gender Description
Not provided
Minimum Age
18 Years
Maximum Age
Not provided
Standard Ages
AdultOlder Adult
Study Population
Not provided
Sampling Method
Not provided
Contacts/Locations Module
Central Contacts
Not provided
Overall Officials
Name
Affiliation
Role
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)
Tolaney SM, Sahebjam S, Le Rhun E, Bachelot T, Kabos P, Awada A, Yardley D, Chan A, Conte P, Dieras V, Lin NU, Bear M, Chapman SC, Yang Z, Chen Y, Anders CK. A Phase II Study of Abemaciclib in Patients with Brain Metastases Secondary to Hormone Receptor-Positive Breast Cancer. Clin Cancer Res. 2020 Oct 15;26(20):5310-5319. doi: 10.1158/1078-0432.CCR-20-1764. Epub 2020 Jul 21.
See Also Links
Label
URL
Click here for more information about this study: A Study of Abemaciclib (LY2835219) in Participants With Breast Cancer, Non-small Cell Lung Cancer, or Melanoma that has Spread to the Brain
Anonymized individual patient level data will be provided in a secure access environment upon approval of a research proposal and a signed data sharing agreement.
Types
Study Protocol
Statistical Analysis Plan (SAP)
Clinical Study Report (CSR)
Time Frame
Data are available 6 months after the primary publication and approval of the indication studied in the US and European Union (EU), whichever is later. Data will be indefinitely available for requesting.
Access Criteria
A research proposal must be approved by an independent review panel and researchers must sign a data sharing agreement.
Completers include participants who died or discontinued study treatment due to progressive disease and is in follow up.
Recruitment Details
Not provided
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
FG000
Part A Abemaciclib: Hormone Receptor (HR+) HER2+ Breast Cancer
Abemaciclib 200 milligram (mg) was administered orally once every 12 hours on days 1-21 of a 21-day cycle when administered as a single agent or in combination with endocrine therapy (ET). Participants with hormone receptor positive (HR+), hormone epidermal growth factor receptor 2 positive (HER2+) breast cancer receiving concurrent trastuzumab, 150 mg abemaciclib was 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.
Periods
Title
Milestones
Reasons Not Completed
Overall Study
Type
Comment
Milestone Data
STARTED
Baseline Characteristics Module
Baseline Analysis Population Description
Outcome Measures Module
Outcome Measures
Adverse Events Module
Frequency Threshold
5
More Info Module
Limitations and Caveats
Not provided
Annotation Section
No data available
No data is available for this block.
Document Section
Large Document Module
Document Has No Statistical Analysis Plan (SAP)
Not provided
Uploaded Document Information
Type
Includes Protocol
Includes SAP
Includes ICF
Document Label
Document Date
Document Uploaded Date
Document File Name
Prot
Yes
No
No
Study Protocol: Protocol
Nov 11, 2014
Aug 30, 2019
Derived Section
Miscellaneous Info Module
Version Holder
Jul 10, 2026
Removed Countries
New Zealand
Submission Tracking
No data available
No data is available for this block.
Condition Browse Module
MeSH Terms
Intervention Browse Module
MeSH Terms
Non-Randomized
Intervention Model
Single Group Assignment
Intervention Model Description
Not provided
Primary Purpose
Treatment
Observational Model
Not provided
Time Perspective
Not provided
Masking Info
Masking
None (Open Label)
Masking Description
Not provided
Who Masked
Not provided
Experimental
Abemaciclib 200 mg was administered orally once every 12 hours on days 1-21 of a 21-day cycle. Participants with NSCLC receiving concurrent gemcitabine or pemetrexed, 150 mg abemaciclib was 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
Part E Abemaciclib: Melanoma
Experimental
Abemaciclib 200 mg was administered 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
Part F Abemaciclib: HR+ Breast Cancer, NSCLC, or Melanoma
Experimental
Abemaciclib 200 mg was administered orally once every 12 hours on days 1-21 of a 21-day cycle when administered as a single agent or for participants with breast cancer in combination with endocrine therapy (ET). Participants with HR+ (either HER2+ or HER2-) breast cancer, NSCLC, or melanoma and leptomeningeal metastases received concurrent trastuzumab, gemcitabine, or pemetrexed, 150 mg abemaciclib was 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
Part D Abemaciclib: Non-Small Cell Lung Cancer (NSCLC)
Part E Abemaciclib: Melanoma
Part F Abemaciclib: HR+ Breast Cancer, NSCLC, or Melanoma
LY2835219
Baseline to Earliest Objective Progression or Start of New Anticancer Therapy (Up to 36 Months)
Duration of CR or PR: Duration of Intracranial Response (DOIR)
DOIR is measured from the date of first evidence of a confirmed response (CR or PR), as defined by RANO-BM, to the date objective progression or death from any cause. CR is measurable target lesions, the disappearance of all CNS target lesions for at least 4 weeks; no new lesions; no corticosteroids; stable or improved clinically. PR is at least a 30% decrease in the sum LD of CNS target lesions, taking as reference the baseline sum LD for at least 4 weeks; no new lesions; stable to decreased corticosteroid dose; stable or improved clinically. Participants who have neither progressed nor died were censored on the day of their last radiographic tumor assessment or on the date of response. PD is greater than or equal to (≥) 20% increase in sum LD relative to nadir and a relative increase of 20%, ≥1 lesion must increase by absolute value of ≥5 mm. DOIR was summarized using Kaplan-Meier estimates.
Date of CR or PR to Date of Objective Disease Progression or Death from Any Cause (Up to 36 Months)
Percentage of Participants With Best Overall Intracranial Response (BOIR) of CR, PR, or SD: Intracranial Disease Control Rate (IDCR)
Percentage of participants with BOIR of CR, PR, or SD: IDCR, as defined by RANO-BM is reported. CR is measurable target lesions, the disappearance of all central nervous system CNS target lesions for at least 4 weeks; no new lesions; no corticosteroids; stable or improved clinically. PR is at least a 30% decrease in the sum LD of CNS target lesions, taking as reference the baseline sum LD for at least 4 weeks; no new lesions; stable to decreased corticosteroid dose; stable or improved clinically. Nontarget lesions requires disappearance CNS non-target lesions and no new CNS lesions. SD is less than (<)30% decrease relative to baseline but <20% increase in sum LD relative to nadir. PD is greater than or equal to (≥) 20% increase in sum LD relative to nadir and a relative increase of 20%, ≥1 lesion must increase by absolute value of ≥5 mm.
Baseline to Disease Progression or Start of New Anticancer Therapy (Up to 36 Months)
Percentage of Participants With BOIR of CR, PR, or SD With Duration of SD for at Least 6 Months: Intracranial Clinical Benefit Rate (ICBR)
ICBR is the percentage of participants with BOIR of CR, PR, or SD with duration of SD for at least 6 months, as defined by RANO-BM. CR is measurable target lesions, the disappearance of all CNS target lesions for at least 4 weeks; no new lesions; no corticosteroids; stable or improved clinically. PR is at least a 30% decrease in the sum LD of CNS target lesions, taking as reference the baseline sum LD for at least 4 weeks; no new lesions; stable to decreased corticosteroid dose; stable or improved clinically. SD is <30% decrease relative to baseline but <20% increase in sum LD relative to nadir. PD is greater than or equal to (≥) 20% increase in sum LD relative to nadir and a relative increase of 20%, ≥1 lesion must increase by absolute value of ≥5 mm.
Baseline to Disease Progression or Start of New Anticancer Therapy (Up to 36 Months)
Overall Survival (OS)
OS was measured from baseline to the date of death from any cause. For each participant who is not known to have died as of the data-inclusion cutoff date for a particular analysis, OS was censored for that analysis at the date of last contact prior to the data inclusion cutoff date (contacts considered in the determination of last contact date include adverse event (AE) date, tumor assessment date, visit date, and last known alive date). OS was summarized using Kaplan-Meier estimates.
Baseline to the Date of Death from Any Cause (Up to 5 Years)
Percentage of Participants With a Best Response of CR or PR: Extracranial Objective Response Rate (EORR)
The percentage of participants with a best response of CR or PR objective response rate is complete response (CR) + partial response (PR), as classified by the investigators according to the Response Evaluation Criteria In Solid Tumors (RECIST v1.1) guidelines. CR is disappearance of all target and non-target lesions; PR is ≥30% decrease in sum of longest diameter of target lesions. PD is defined as at least a 20% increase in the sum LD of CNS target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study) and the 20% increase must be at least one lesion must increase by an absolute value of ≥5 mm to be considered progression.
Baseline to Disease Progression (Up to 36 Months)
Percentage of Participants With a Best Overall Response of CR, PR, or SD: Extracranial Disease Control Rate (EDCR)
Disease control rate (DCR) (CR+ PR+ SD) per RECIST v1.1. is defined as the percentage of participants with best overall response of CR, PR, or SD. CR is disappearance of all target and non-target lesions; PR is ≥30% decrease in sum of longest diameter of target lesions. PD is defined as at least a 20% increase in the sum LD of CNS target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study) and the 20% increase must be at least one lesion must increase by an absolute value of ≥5 mm to be considered progression.
Baseline to Disease Progression or Start of New Anticancer Therapy (Up to 36 Months)
Progression Free Survival (PFS) Bi-compartmental
PFS was measured from baseline to objective progression (intracranial or extracranial) as defined by (RANO-BM.) or death from any cause. Participants who have neither progressed nor died were censored at the day of their last radiographic tumor assessment. PD is greater than or equal to (≥) 20% increase in sum LD relative to nadir and a relative increase of 20%, ≥1 lesion must increase by absolute value of ≥5 mm. PFS was summarized using Kaplan-Meier estimates.
Baseline to Objective Disease Progression or Death from Any Cause (Up to 36 Months)
Change From Baseline in Neurologic Symptoms on the MD Anderson Inventory-Brain Tumor (MDASI-BT) Subscale
The MDASI-BT is an instrument to assess multi-symptoms in participants with brain tumor metastases (including those with brain metastases secondary to breast cancer). The MDASI-BT of participants with a change from baseline is reported as mean core symptoms, mean brain tumor symptoms, and symptom groupings (mean focal neurologic deficit, mean generalized/disease status symptoms, and mean gastrointestinal symptoms). The mean of all symptom subscale items was calculated where 0 equals "not present" and 10 equals "as bad as you can imagine." A change from baseline with negative values indicate improvement, positive values indicate worsening.
Baseline, Cycle 3 (Up to 63 Days)
Pharmacokinetics (PK): Steady State Minimum Concentration (Cmin) of Abemaciclib and Its Metabolites LSN2839567 (M2), LSN3106726 (M20), and LSN3106729 (M18)
A PK plasma sample was taken prior to abemaciclib dose to analyze the minimum concentrations of abemaciclib and its metabolites (Cmin) - Individual Cmin values were averaged if there were 3 or more available data points, otherwise individual data are reported.
Parts A, B, D, E, F, Cycle 3, Day 1: Predose; Part C, Cycle 4, Day 1: Predose
La Jolla
California
92037-0845
United States
Univ of California San Francisco
San Francisco
California
94115
United States
John Wayne Cancer Institute
Santa Monica
California
90404
United States
University of Colorado
Aurora
Colorado
80045
United States
Georgetown University Medical Center
Washington D.C.
District of Columbia
20007
United States
Florida Cancer Specialists
Fort Myers
Florida
33916-2233
United States
H Lee Moffitt Cancer Center
Tampa
Florida
33612-9497
United States
Kaiser Permanente Center for Health Research
Honolulu
Hawaii
96819
United States
James Graham Brown Cancer Center
Louisville
Kentucky
40202
United States
Dana Farber Cancer Institute
Boston
Massachusetts
02215
United States
University of Michigan
Ann Arbor
Michigan
48109
United States
Washington University Medical Center
St Louis
Missouri
63110
United States
Memorial Sloan Kettering Cancer Center
New York
New York
10065
United States
University of North Carolina at Chapel Hill
Chapel Hill
North Carolina
27599
United States
Providence Health and Services
Portland
Oregon
97213
United States
SMO Sarah Cannon Research Inst.
Nashville
Tennessee
37203
United States
Tennessee Oncology PLLC
Nashville
Tennessee
37203
United States
University of Texas MD Anderson Cancer Center
Houston
Texas
77030
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
6009
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
2298
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
4215
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
4102
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
1090
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
1000
Belgium
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.
Charleroi
6000
Belgium
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Leuven
3000
Belgium
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.
Liège
4000
Belgium
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.
Ottawa
K1H 8L6
Canada
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.
Lille
59020
France
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.
Lille
59037
France
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Lyon
69373
France
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Paris
75248
France
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Saint-Brieuc
22027
France
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Toulouse
31059
France
Hadassah Medical Center - Ein Karem
Jerusalem
9112001
Israel
Sheba Medical Center
Tel Litwinsky
5265601
Israel
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.
Cona
44124
Italy
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Genova
16132
Italy
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Padova
35128
Italy
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Roma
00128
Italy
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Barcelona
08035
Spain
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.
Madrid
28034
Spain
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.
Seville
41013
Spain
FG001
Part B Abemaciclib: HR+, HER2- Breast Cancer
Abemaciclib 200 mg was administered orally once every 12 hours on days 1-21 of a 21-day cycle when administered as a single agent or in combination with endocrine therapy (ET).
Participants may continue to receive treatment until discontinuation criteria are met.
FG002
Part C Abemaciclib: Surgical Resection
Abemaciclib 200 mg was administered orally once every 12 hours on days 1-21 of a 21-day cycle when administered as a single agent or for participants with breast cancer in combination with endocrine therapy (ET). Participants with HR+, HER2+ breast cancer, NSCLC, or melanoma with intracranial lesions for which surgical resection is clinically indicated receiving concurrent trastuzumab, gemcitabine, or pemetrexed, 150 mg abemaciclib was 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.
FG003
Part D Abemaciclib: Non-Small Cell Lung Cancer (NSCLC)
Abemaciclib 200 mg was administered orally once every 12 hours on days 1-21 of a 21-day cycle. Participants with NSCLC receiving concurrent gemcitabine or pemetrexed, 150 mg abemaciclib was 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.
FG004
Part E Abemaciclib: Melanoma
Abemaciclib 200 mg was administered 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.
FG005
Part F Abemaciclib: HR+ Breast Cancer, NSCLC, or Melanoma
Abemaciclib 200 mg was administered orally once every 12 hours on days 1-21 of a 21-day cycle when administered as a single agent or for participants with breast cancer in combination with endocrine therapy (ET). Participants with HR+ (either HER2+ or HER2-) breast cancer, NSCLC, or melanoma and leptomeningeal metastases received concurrent trastuzumab, gemcitabine, or pemetrexed, 150 mg abemaciclib was 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.
FG00027 subjects
FG00158 subjects
FG0029 subjects
FG00328 subjects
FG00423 subjects
FG00517 subjects
Received at Least One Dose of Study Drug
FG00027 subjects
FG00158 subjects
FG0029 subjects
FG00328 subjects
FG00423 subjects
FG00517 subjects
COMPLETED
FG00023 subjects
FG00138 subjects
FG0026 subjects
FG00324 subjects
FG00419 subjects
FG00512 subjects
NOT COMPLETED
FG0004 subjects
FG00120 subjects
FG0023 subjects
FG0034 subjects
FG0044 subjects
FG0055 subjects
Type
Comment
Reasons
Lost to Follow-up
FG0001 subjects
FG0017 subjects
FG0020 subjects
FG0030 subjects
FG0041 subjects
FG0052 subjects
Sponsor Decision
FG0000 subjects
FG0018 subjects
FG0020 subjects
FG0032 subjects
FG004
Withdrawal by Subject
FG0003 subjects
FG0015 subjects
FG0023 subjects
FG0032 subjects
FG004
All participants who received at least one dose of study drug.
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
BG000
Part A Abemaciclib: HR+, HER2+ Breast Cancer
Abemaciclib 200 mg was administered orally once every 12 hours on days 1-21 of a 21-day cycle when administered as a single agent or in combination with endocrine therapy (ET). Participants with hormone receptor positive HR+, HER2+ breast cancer receiving concurrent trastuzumab, 150 mg abemaciclib was 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.
BG001
Part B Abemaciclib: HR+, HER2- Breast Cancer
Abemaciclib 200 mg was administered orally once every 12 hours on days 1-21 of a 21-day cycle when administered as a single agent or in combination with endocrine therapy (ET).
Participants may continue to receive treatment until discontinuation criteria are met.
BG002
Part C Abemaciclib: Surgical Resection
Abemaciclib 200 mg was administered orally once every 12 hours on days 1-21 of a 21-day cycle when administered as a single agent or for participants with breast cancer in combination with endocrine therapy (ET). Participants with HR+, HER2+ breast cancer, NSCLC, or melanoma with intracranial lesions for which surgical resection is clinically indicated receiving concurrent trastuzumab, gemcitabine, or pemetrexed, 150 mg abemaciclib was 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.
BG003
Part D Abemaciclib: NSCLC
Abemaciclib 200 mg was administered orally once every 12 hours on days 1-21 of a 21-day cycle. Participants with NSCLC receiving concurrent gemcitabine or pemetrexed, 150 mg abemaciclib was 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.
BG004
Part E Abemaciclib: Melanoma
Abemaciclib 200 mg was administered 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.
BG005
Part F Abemaciclib: HR+ Breast Cancer, NSCLC, or Melanoma
Abemaciclib 200 mg was administered orally once every 12 hours on days 1-21 of a 21-day cycle when administered as a single agent or for participants with breast cancer in combination with endocrine therapy (ET). Participants with HR+ (either HER2+ or HER2-) breast cancer, NSCLC, or melanoma and leptomeningeal metastases received concurrent trastuzumab, gemcitabine, or pemetrexed, 150 mg abemaciclib was 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.
BG006
Total
Total of all reporting groups
Denominators
Units
Counts
Participants
BG00027
BG00158
BG0029
BG00328
BG00423
BG00517
BG006162
Baseline Measures
Title
Description
Population Description
Parameter Type
Dispersion Type
Unit of Measure
Calculate Percentage
Denominator Units Selected
Denominators
Classes
Age, Continuous
Mean
Standard Deviation
years
Title
Denominators
Categories
Title
Measurements
BG00049.9± 10.9
BG00154.1± 10.5
BG00257.0± 17.9
BG003
Sex: Female, Male
Count of Participants
Participants
No
Title
Denominators
Categories
Title
Measurements
Female
BG00027
BG00157
BG002
Ethnicity (NIH/OMB)
Count of Participants
Participants
No
Title
Denominators
Categories
Title
Measurements
Hispanic or Latino
BG0000
BG0013
BG002
Race (NIH/OMB)
Count of Participants
Participants
No
Title
Denominators
Categories
Title
Measurements
American Indian or Alaska Native
BG0000
BG0010
BG002
Region of Enrollment
Count of Participants
Participants
No
Title
Denominators
Categories
Canada
Title
Measurements
BG0000
BG0011
BG002
Type
Title
Description
Population Description
Reporting Status
Anticipated Posting Date
Parameter Type
Dispersion Type
Unit of Measure
Calculate Percentage
Time Frame
Units Analyzed
Denominator Units Selected
Arm/Group Information
Denominators
Classes
Analyses
Primary
Percentage of Participants Achieving Complete Response (CR) or Partial Response (PR): Objective Intracranial Response Rate (OIRR)
OIRR is the percentage of participants with a (CR) or (PR) based on the Response Assessment in Neuro-Oncology Brain Metastasis (RANO-BM) response criteria. CR is measurable target lesions, the disappearance of all central nervous system (CNS) target lesions for at least 4 weeks; no new lesions; no corticosteroids; stable or improved clinically. PR is at least a 30% decrease in the sum longest duration (LD) of CNS target lesions, taking as reference the baseline sum LD for at least 4 weeks; no new lesions; stable to decreased corticosteroid dose; stable or improved clinically. Nontarget lesions requires disappearance CNS non-target lesions and no new CNS lesions. Stable disease (SD) is less than (<)30% decrease relative to baseline but <20% increase in sum LD relative to nadir. Progressive disease (PD) is greater than or equal to (≥) 20% increase in sum LD relative to nadir and a relative increase of 20%, ≥1 lesion must increase by absolute value of ≥5 millimeter (mm).
All participants who had evaluable OIRR data with at least one measurable brain lesion at baseline (per RANO-BM) and for whom at least one post-baseline overall response assessment for intracranial disease is available. Parts C and F were exploratory per protocol.
Posted
Number
percentage of participants
Baseline to Objective Disease Progression (Up to 36 Months)
ID
Title
Description
OG000
Part A Abemaciclib: HR+, HER2+ Breast Cancer
Abemaciclib 200 mg was administered orally once every 12 hours on days 1-21 of a 21-day cycle when administered as a single agent or in combination with endocrine therapy (ET). Participants with hormone receptor positive HR+, HER2+ breast cancer receiving concurrent trastuzumab, 150 mg abemaciclib was 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.
OG001
Part B Abemaciclib: HR+, HER2- Breast Cancer
Abemaciclib 200 mg was administered orally once every 12 hours on days 1-21 of a 21-day cycle when administered as a single agent or for in combination with endocrine therapy (ET).
Participants may continue to receive treatment until discontinuation criteria are met.
OG002
Part D Abemaciclib: NSCLC
Abemaciclib 200 mg was administered orally once every 12 hours on days 1-21 of a 21-day cycle. Participants with NSCLC receiving concurrent gemcitabine or pemetrexed, 150 mg abemaciclib was 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.
OG003
Part E Abemaciclib: Melanoma
Abemaciclib 200 mg was administered 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.
Units
Counts
Participants
OG00023
OG00152
OG00223
OG003
Title
Denominators
Categories
Title
Measurements
OG0000
OG0015.8
OG0020
OG003
Secondary
Percentage of Participants With CR, PR, Stable Disease (SD), Progressive Disease (PD), or Not Evaluable (NE): Best Overall Intracranial Response (BOIR)
Percentage of Participants with BOIR was categorized as CR, PR, SD, PD or NE, as defined by RANO-BM, from baseline until the earliest of objective progression according to brain metastases response criteria or start of new anticancer therapy. CR is measurable target lesions, the disappearance of all CNS target lesions for at least 4 weeks; no new lesions; no corticosteroids; stable or improved clinically. PR is at least a 30% decrease in the sum LD of CNS target lesions, taking as reference the baseline sum LD for at least 4 weeks; no new lesions; stable to decreased corticosteroid dose; stable or improved clinically. SD is <30% decrease relative to baseline but <20% increase in sum LD relative to nadir. PD is greater than or equal to (≥) 20% increase in sum LD relative to nadir and a relative increase of 20%, ≥1 lesion must increase by absolute value of ≥5 mm. NE is absent (no abnormality; normal), or non-evaluable (NE).
All participants who had evaluable OIRR data with at least one measurable brain lesion at baseline (per RANO-BM) and for whom at least one post-baseline overall response assessment for intracranial disease is available. Parts C and F were exploratory per protocol.
Posted
Number
percentage of participants
Baseline to Earliest Objective Progression or Start of New Anticancer Therapy (Up to 36 Months)
ID
Title
Description
OG000
Part A Abemaciclib: HR+, HER2+ Breast Cancer
Abemaciclib 200 mg was administered orally once every 12 hours on days 1-21 of a 21-day cycle when administered as a single agent or in combination with endocrine therapy (ET). Participants with hormone receptor positive HR+, HER2+ breast cancer receiving concurrent trastuzumab, 150 mg abemaciclib was 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.
Secondary
Duration of CR or PR: Duration of Intracranial Response (DOIR)
DOIR is measured from the date of first evidence of a confirmed response (CR or PR), as defined by RANO-BM, to the date objective progression or death from any cause. CR is measurable target lesions, the disappearance of all CNS target lesions for at least 4 weeks; no new lesions; no corticosteroids; stable or improved clinically. PR is at least a 30% decrease in the sum LD of CNS target lesions, taking as reference the baseline sum LD for at least 4 weeks; no new lesions; stable to decreased corticosteroid dose; stable or improved clinically. Participants who have neither progressed nor died were censored on the day of their last radiographic tumor assessment or on the date of response. PD is greater than or equal to (≥) 20% increase in sum LD relative to nadir and a relative increase of 20%, ≥1 lesion must increase by absolute value of ≥5 mm. DOIR was summarized using Kaplan-Meier estimates.
All participants who had a confirmed intracranial response of CR or PR (per RANO-BM) and for whom at least one post-baseline overall intracranial response with a measurable duration is available. Parts C and F were exploratory per protocol.
Posted
Median
Full Range
Months
Date of CR or PR to Date of Objective Disease Progression or Death from Any Cause (Up to 36 Months)
ID
Title
Description
OG000
Part A Abemaciclib: HR+, HER2+ Breast Cancer
Abemaciclib 200 mg was administered orally once every 12 hours on days 1-21 of a 21-day cycle when administered as a single agent or in combination with endocrine therapy (ET). Participants with hormone receptor positive HR+, HER2+ breast cancer receiving concurrent trastuzumab, 150 mg abemaciclib was 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.
Secondary
Percentage of Participants With Best Overall Intracranial Response (BOIR) of CR, PR, or SD: Intracranial Disease Control Rate (IDCR)
Percentage of participants with BOIR of CR, PR, or SD: IDCR, as defined by RANO-BM is reported. CR is measurable target lesions, the disappearance of all central nervous system CNS target lesions for at least 4 weeks; no new lesions; no corticosteroids; stable or improved clinically. PR is at least a 30% decrease in the sum LD of CNS target lesions, taking as reference the baseline sum LD for at least 4 weeks; no new lesions; stable to decreased corticosteroid dose; stable or improved clinically. Nontarget lesions requires disappearance CNS non-target lesions and no new CNS lesions. SD is less than (<)30% decrease relative to baseline but <20% increase in sum LD relative to nadir. PD is greater than or equal to (≥) 20% increase in sum LD relative to nadir and a relative increase of 20%, ≥1 lesion must increase by absolute value of ≥5 mm.
All participants who had evaluable OIRR data with at least one measurable brain lesion at baseline (per RANO-BM) and for whom at least one post-baseline overall response assessment. Parts C and F were exploratory per protocol.
Posted
Number
percentage of participants
Baseline to Disease Progression or Start of New Anticancer Therapy (Up to 36 Months)
ID
Title
Description
OG000
Part A Abemaciclib: HR+, HER2+ Breast Cancer
Abemaciclib 200 mg was administered orally once every 12 hours on days 1-21 of a 21-day cycle when administered as a single agent or in combination with endocrine therapy (ET). Participants with hormone receptor positive HR+, HER2+ breast cancer receiving concurrent trastuzumab, 150 mg abemaciclib was 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.
Secondary
Percentage of Participants With BOIR of CR, PR, or SD With Duration of SD for at Least 6 Months: Intracranial Clinical Benefit Rate (ICBR)
ICBR is the percentage of participants with BOIR of CR, PR, or SD with duration of SD for at least 6 months, as defined by RANO-BM. CR is measurable target lesions, the disappearance of all CNS target lesions for at least 4 weeks; no new lesions; no corticosteroids; stable or improved clinically. PR is at least a 30% decrease in the sum LD of CNS target lesions, taking as reference the baseline sum LD for at least 4 weeks; no new lesions; stable to decreased corticosteroid dose; stable or improved clinically. SD is <30% decrease relative to baseline but <20% increase in sum LD relative to nadir. PD is greater than or equal to (≥) 20% increase in sum LD relative to nadir and a relative increase of 20%, ≥1 lesion must increase by absolute value of ≥5 mm.
All participants who had evaluable OIRR data with at least one measurable brain lesion at baseline (per RANO-BM) and for whom at least one post-baseline overall response assessment for intracranial disease is available. Parts C and F were exploratory per protocol.
Posted
Number
percentage of participants
Baseline to Disease Progression or Start of New Anticancer Therapy (Up to 36 Months)
ID
Title
Description
OG000
Part A Abemaciclib: HR+, HER2+ Breast Cancer
Abemaciclib 200 mg was administered orally once every 12 hours on days 1-21 of a 21-day cycle when administered as a single agent or in combination with endocrine therapy (ET). Participants with hormone receptor positive HR+, HER2+ breast cancer receiving concurrent trastuzumab, 150 mg abemaciclib was 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.
Secondary
Overall Survival (OS)
OS was measured from baseline to the date of death from any cause. For each participant who is not known to have died as of the data-inclusion cutoff date for a particular analysis, OS was censored for that analysis at the date of last contact prior to the data inclusion cutoff date (contacts considered in the determination of last contact date include adverse event (AE) date, tumor assessment date, visit date, and last known alive date). OS was summarized using Kaplan-Meier estimates.
All participants who received at least one dose of study drug. Parts C and F were exploratory per protocol. Censored participants in Part A = 4, Part B = 20, Part D = 4, Part E = 4.
Posted
Median
95% Confidence Interval
months
Baseline to the Date of Death from Any Cause (Up to 5 Years)
ID
Title
Description
OG000
Part A Abemaciclib: HR+, HER2+ Breast Cancer
Abemaciclib 200 mg was administered orally once every 12 hours on days 1-21 of a 21-day cycle when administered as a single agent or in combination with endocrine therapy (ET). Participants with hormone receptor positive HR+, HER2+ breast cancer receiving concurrent trastuzumab, 150 mg abemaciclib was 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.
OG001
Part B Abemaciclib: HR+, HER2- Breast Cancer
Abemaciclib 200 mg was administered orally once every 12 hours on days 1-21 of a 21-day cycle when administered as a single agent or in combination with endocrine therapy (ET).
Participants may continue to receive treatment until discontinuation criteria are met.
Secondary
Percentage of Participants With a Best Response of CR or PR: Extracranial Objective Response Rate (EORR)
The percentage of participants with a best response of CR or PR objective response rate is complete response (CR) + partial response (PR), as classified by the investigators according to the Response Evaluation Criteria In Solid Tumors (RECIST v1.1) guidelines. CR is disappearance of all target and non-target lesions; PR is ≥30% decrease in sum of longest diameter of target lesions. PD is defined as at least a 20% increase in the sum LD of CNS target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study) and the 20% increase must be at least one lesion must increase by an absolute value of ≥5 mm to be considered progression.
All participants who received at least one dose of study drug. Parts C and F were exploratory per protocol.
Posted
Number
percentage of participants
Baseline to Disease Progression (Up to 36 Months)
ID
Title
Description
OG000
Part A Abemaciclib: HR+, HER2+ Breast Cancer
Abemaciclib 200 mg was administered orally once every 12 hours on days 1-21 of a 21-day cycle when administered as a single agent or in combination with endocrine therapy (ET). Participants with hormone receptor positive HR+, HER2+ breast cancer receiving concurrent trastuzumab, 150 mg abemaciclib was 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.
OG001
Part B Abemaciclib: HR+, HER2- Breast Cancer
Secondary
Percentage of Participants With a Best Overall Response of CR, PR, or SD: Extracranial Disease Control Rate (EDCR)
Disease control rate (DCR) (CR+ PR+ SD) per RECIST v1.1. is defined as the percentage of participants with best overall response of CR, PR, or SD. CR is disappearance of all target and non-target lesions; PR is ≥30% decrease in sum of longest diameter of target lesions. PD is defined as at least a 20% increase in the sum LD of CNS target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study) and the 20% increase must be at least one lesion must increase by an absolute value of ≥5 mm to be considered progression.
All participants who received at least one dose of study drug. Parts C and F were exploratory per protocol.
Posted
Number
percentage of participants
Baseline to Disease Progression or Start of New Anticancer Therapy (Up to 36 Months)
ID
Title
Description
OG000
Part A Abemaciclib: HR+, HER2+ Breast Cancer
Abemaciclib 200 mg was administered orally once every 12 hours on days 1-21 of a 21-day cycle when administered as a single agent or in combination with endocrine therapy (ET). Participants with hormone receptor positive HR+, HER2+ breast cancer receiving concurrent trastuzumab, 150 mg abemaciclib was 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.
OG001
Part B Abemaciclib: HR+, HER2- Breast Cancer
Secondary
Progression Free Survival (PFS) Bi-compartmental
PFS was measured from baseline to objective progression (intracranial or extracranial) as defined by (RANO-BM.) or death from any cause. Participants who have neither progressed nor died were censored at the day of their last radiographic tumor assessment. PD is greater than or equal to (≥) 20% increase in sum LD relative to nadir and a relative increase of 20%, ≥1 lesion must increase by absolute value of ≥5 mm. PFS was summarized using Kaplan-Meier estimates.
All participants who received at least one dose of study drug. Censored participants Part A = 1, Part B =2, Part D = 1 and Part E = 1. Parts C and F were exploratory per protocol.
Posted
Median
95% Confidence Interval
Months
Baseline to Objective Disease Progression or Death from Any Cause (Up to 36 Months)
ID
Title
Description
OG000
Part A Abemaciclib: HR+, HER2+ Breast Cancer
Abemaciclib 200 mg was administered orally once every 12 hours on days 1-21 of a 21-day cycle when administered as a single agent or in combination with endocrine therapy (ET). Participants with hormone receptor positive HR+, HER2+ breast cancer receiving concurrent trastuzumab, 150 mg abemaciclib was 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.
OG001
Part B Abemaciclib: HR+, HER2- Breast Cancer
Abemaciclib 200 mg was administered orally once every 12 hours on days 1-21 of a 21-day cycle when administered as a single agent or in combination with endocrine therapy (ET).
Participants may continue to receive treatment until discontinuation criteria are met.
Secondary
Change From Baseline in Neurologic Symptoms on the MD Anderson Inventory-Brain Tumor (MDASI-BT) Subscale
The MDASI-BT is an instrument to assess multi-symptoms in participants with brain tumor metastases (including those with brain metastases secondary to breast cancer). The MDASI-BT of participants with a change from baseline is reported as mean core symptoms, mean brain tumor symptoms, and symptom groupings (mean focal neurologic deficit, mean generalized/disease status symptoms, and mean gastrointestinal symptoms). The mean of all symptom subscale items was calculated where 0 equals "not present" and 10 equals "as bad as you can imagine." A change from baseline with negative values indicate improvement, positive values indicate worsening.
All participants who received at least one dose of study drug and had at least 1 baseline and an evaluable post baseline assessment. Parts C and F were exploratory per protocol.
Posted
Mean
Standard Deviation
units on a scale
Baseline, Cycle 3 (Up to 63 Days)
ID
Title
Description
OG000
Part A Abemaciclib: HR+, HER2+ Breast Cancer
Abemaciclib 200 mg was administered orally once every 12 hours on days 1-21 of a 21-day cycle when administered as a single agent or for in combination with endocrine therapy (ET). Participants with hormone receptor positive HR+, HER2+ breast cancer receiving concurrent trastuzumab, 150 mg abemaciclib was 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.
OG001
Part B Abemaciclib: HR+, HER2- Breast Cancer
Secondary
Pharmacokinetics (PK): Steady State Minimum Concentration (Cmin) of Abemaciclib and Its Metabolites LSN2839567 (M2), LSN3106726 (M20), and LSN3106729 (M18)
A PK plasma sample was taken prior to abemaciclib dose to analyze the minimum concentrations of abemaciclib and its metabolites (Cmin) - Individual Cmin values were averaged if there were 3 or more available data points, otherwise individual data are reported.
All participants who had evaluable PK data.
Posted
Geometric Mean
Geometric Coefficient of Variation
nanogram/milliliter (ng/mL)
Parts A, B, D, E, F, Cycle 3, Day 1: Predose; Part C, Cycle 4, Day 1: Predose
ID
Title
Description
OG000
Part A 150 mg Abemaciclib: HR+, HER2+ Breast Cancer
Participants with HR+, HER2+ breast cancer received 150 mg abemaciclib orally once every 12 hours on days 1-21 of a 21-day cycle.
OG001
Part B 200 mg Abemaciclib: HR+, HER2- Breast Cancer
Participants with HR+, HER2- breast cancer received 200 mg abemaciclib given orally once every 12 hours on days 1-21 of a 21-day cycle.
OG002
Part C 200 mg Abemaciclib: Surgical Resection
Participants with HR+ breast cancer, NSCLC, or melanoma with intracranial lesions for which surgical resection is clinically indicated received 200 mg abemaciclib given orally once every 12 hours for 5-14 days prior to surgical resection.
Time Frame
Up to 36 Months
Description
All participants who received at least one dose of study drug.
All-Cause Mortality Comment
Not provided
Arm/Groups
ID
Title
Description
Deaths (Affected)
Deaths (At Risk)
Serious Events (Affected)
Serious Events (At Risk)
Other Events (Affected)
Other Events (At Risk)
EG000
Part A Abemaciclib: HR+, HER2+ Breast Cancer
Abemaciclib 200 mg was administered orally once every 12 hours on days 1-21 of a 21-day cycle when administered as a single agent or in combination with Endocrine Therapy (ET). Participants with hormone receptor positive HR+, HER2+ breast cancer receiving concurrent trastuzumab, 150 mg abemaciclib was 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.
23
27
6
27
23
27
EG001
Part B Abemaciclib: HR+, HER2- Breast Cancer
Abemaciclib 200 mg was administered orally once every 12 hours on days 1-21 of a 21-day cycle when administered as a single agent or in combination with Endocrine Therapy (ET).
Participants may continue to receive treatment until discontinuation criteria are met.
38
58
16
58
55
58
EG002
Part C Abemaciclib: Surgical Resection
Abemaciclib 200 mg was administered orally once every 12 hours on days 1-21 of a 21-day cycle when administered as a single agent or for participants with breast cancer in combination with Endocrine Therapy (ET). Participants with HR+, HER2+ breast cancer, NSCLC, or melanoma with intracranial lesions for which surgical resection is clinically indicated receiving concurrent trastuzumab, gemcitabine, or pemetrexed, 150 mg abemaciclib was 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.
6
9
3
9
8
9
EG003
Part D Abemaciclib: NSCLC
Abemaciclib 200 mg was administered orally once every 12 hours on days 1-21 of a 21-day cycle. Participants with NSCLC receiving concurrent gemcitabine or pemetrexed, 150 mg abemaciclib was 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.
24
28
8
28
27
28
EG004
Part E Abemaciclib: Melanoma
Abemaciclib 200 mg was administered 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.
19
23
4
23
16
23
EG005
Part F: Abemaciclib HR+ Breast Cancer, NSCLC, or Melanoma
Abemaciclib 200 mg was administered orally once every 12 hours on days 1-21 of a 21-day cycle when administered as a single agent or for participants with breast cancer in combination with Endocrine Therapy (ET). Participants with HR+ (either HER2+ or HER2-) breast cancer, NSCLC, or melanoma and leptomeningeal metastases received concurrent trastuzumab, gemcitabine, or pemetrexed, 150 mg abemaciclib was 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.
12
17
7
17
16
17
Serious Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Anaemia
Blood and lymphatic system disorders
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected27 at risk
EG0010 events0 affected58 at risk
EG0020 events0 affected9 at risk
EG0030 events0 affected28 at risk
EG0040 events0 affected23 at risk
EG0051 events1 affected17 at risk
Thrombocytopenia
Blood and lymphatic system disorders
MedDRA 22.0
Systematic Assessment
EG0001 events1 affected27 at risk
EG0010 events0 affected58 at risk
EG0020 events0 affected9 at risk
EG003
Acute coronary syndrome
Cardiac disorders
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected27 at risk
EG0010 events0 affected58 at risk
EG0020 events0 affected9 at risk
EG003
Cardiac failure
Cardiac disorders
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected27 at risk
EG0010 events0 affected58 at risk
EG0020 events0 affected9 at risk
EG003
Myocardial infarction
Cardiac disorders
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected27 at risk
EG0010 events0 affected58 at risk
EG0020 events0 affected9 at risk
EG003
Glaucoma
Eye disorders
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected27 at risk
EG0011 events1 affected58 at risk
EG0020 events0 affected9 at risk
EG003
Diarrhoea
Gastrointestinal disorders
MedDRA 22.0
Systematic Assessment
EG0002 events2 affected27 at risk
EG0012 events2 affected58 at risk
EG0020 events0 affected9 at risk
EG003
Enterocolitis
Gastrointestinal disorders
MedDRA 22.0
Systematic Assessment
EG0001 events1 affected27 at risk
EG0010 events0 affected58 at risk
EG0020 events0 affected9 at risk
EG003
Haemorrhoidal haemorrhage
Gastrointestinal disorders
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected27 at risk
EG0010 events0 affected58 at risk
EG0020 events0 affected9 at risk
EG003
Lower gastrointestinal haemorrhage
Gastrointestinal disorders
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected27 at risk
EG0010 events0 affected58 at risk
EG0020 events0 affected9 at risk
EG003
Nausea
Gastrointestinal disorders
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected27 at risk
EG0010 events0 affected58 at risk
EG0020 events0 affected9 at risk
EG003
Pancreatitis
Gastrointestinal disorders
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected27 at risk
EG0010 events0 affected58 at risk
EG0021 events1 affected9 at risk
EG003
Upper gastrointestinal haemorrhage
Gastrointestinal disorders
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected27 at risk
EG0010 events0 affected58 at risk
EG0020 events0 affected9 at risk
EG003
Vomiting
Gastrointestinal disorders
MedDRA 22.0
Systematic Assessment
EG0001 events1 affected27 at risk
EG0010 events0 affected58 at risk
EG0020 events0 affected9 at risk
EG003
General physical health deterioration
General disorders
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected27 at risk
EG0011 events1 affected58 at risk
EG0020 events0 affected9 at risk
EG003
Pain
General disorders
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected27 at risk
EG0010 events0 affected58 at risk
EG0020 events0 affected9 at risk
EG003
Pyrexia
General disorders
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected27 at risk
EG0012 events2 affected58 at risk
EG0020 events0 affected9 at risk
EG003
Hepatocellular injury
Hepatobiliary disorders
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected27 at risk
EG0010 events0 affected58 at risk
EG0020 events0 affected9 at risk
EG003
Jaundice cholestatic
Hepatobiliary disorders
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected27 at risk
EG0010 events0 affected58 at risk
EG0020 events0 affected9 at risk
EG003
Lung infection
Infections and infestations
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected27 at risk
EG0011 events1 affected58 at risk
EG0020 events0 affected9 at risk
EG003
Sepsis
Infections and infestations
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected27 at risk
EG0011 events1 affected58 at risk
EG0021 events1 affected9 at risk
EG003
Shunt infection
Infections and infestations
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected27 at risk
EG0010 events0 affected58 at risk
EG0020 events0 affected9 at risk
EG003
Skin infection
Infections and infestations
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected27 at risk
EG0010 events0 affected58 at risk
EG0020 events0 affected9 at risk
EG003
Urinary tract infection
Infections and infestations
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected27 at risk
EG0010 events0 affected58 at risk
EG0020 events0 affected9 at risk
EG003
Ankle fracture
Injury, poisoning and procedural complications
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected27 at risk
EG0011 events1 affected58 at risk
EG0020 events0 affected9 at risk
EG003
Fracture
Injury, poisoning and procedural complications
MedDRA 22.0
Systematic Assessment
EG0001 events1 affected27 at risk
EG0010 events0 affected58 at risk
EG0020 events0 affected9 at risk
EG003
Dehydration
Metabolism and nutrition disorders
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected27 at risk
EG0010 events0 affected58 at risk
EG0020 events0 affected9 at risk
EG003
Hypercalcaemia
Metabolism and nutrition disorders
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected27 at risk
EG0011 events1 affected58 at risk
EG0020 events0 affected9 at risk
EG003
Hypokalaemia
Metabolism and nutrition disorders
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected27 at risk
EG0010 events0 affected58 at risk
EG0021 events1 affected9 at risk
EG003
Hyponatraemia
Metabolism and nutrition disorders
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected27 at risk
EG0011 events1 affected58 at risk
EG0020 events0 affected9 at risk
EG003
Back pain
Musculoskeletal and connective tissue disorders
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected27 at risk
EG0011 events1 affected58 at risk
EG0020 events0 affected9 at risk
EG003
Tumour pain
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Abemaciclib 200 mg was administered orally once every 12 hours on days 1-21 of a 21-day cycle when administered as a single agent or in combination with endocrine therapy (ET).
Participants may continue to receive treatment until discontinuation criteria are met.
OG002
Part D Abemaciclib: NSCLC
Abemaciclib 200 mg was administered orally once every 12 hours on days 1-21 of a 21-day cycle. Participants with NSCLC receiving concurrent gemcitabine or pemetrexed, 150 mg abemaciclib was 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.
OG003
Part E Abemaciclib: Melanoma
Abemaciclib 200 mg was administered 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.
Units
Counts
Participants
OG00023
OG00152
OG00223
OG00322
Title
Denominators
Categories
Partial Response
Title
Measurements
OG0000
OG0015.8
OG0020
OG0030
Stable Disease
Title
Measurements
OG00052.2
OG00165.4
OG00243.5
OG003
Progressive Disease
Title
Measurements
OG00047.8
OG00128.8
OG00256.5
OG003
Not Evaluable
Title
Measurements
OG0000
OG0010
OG0020
OG003
OG001
Part B Abemaciclib: HR+, HER2- Breast Cancer
Abemaciclib 200 mg was administered orally once every 12 hours on days 1-21 of a 21-day cycle when administered as a single agent or in combination with endocrine therapy (ET).
Participants may continue to receive treatment until discontinuation criteria are met.
OG002
Part D Abemaciclib: NSCLC
Abemaciclib 200 mg was administered orally once every 12 hours on days 1-21 of a 21-day cycle. Participants with NSCLC receiving concurrent gemcitabine or pemetrexed, 150 mg abemaciclib was 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.
OG003
Part E Abemaciclib: Melanoma
Abemaciclib 200 mg was administered 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.
Units
Counts
Participants
OG0000
OG0013
OG0020
OG0030
Title
Denominators
Categories
Title
Measurements
OG0018.8(3.0 to 14.3)
OG001
Part B Abemaciclib: HR+, HER2- Breast Cancer
Abemaciclib 200 mg was administered orally once every 12 hours on days 1-21 of a 21-day cycle when administered as a single agent or in combination with endocrine therapy (ET).
Participants may continue to receive treatment until discontinuation criteria are met.
OG002
Part D Abemaciclib: NSCLC
Abemaciclib 200 mg was administered orally once every 12 hours on days 1-21 of a 21-day cycle. Participants with NSCLC receiving concurrent gemcitabine or pemetrexed, 150 mg abemaciclib was 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.
OG003
Part E Abemaciclib: Melanoma
Abemaciclib 200 mg was administered 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.
Units
Counts
Participants
OG00023
OG00152
OG00223
OG00322
Title
Denominators
Categories
Title
Measurements
OG00052.2
OG00171.2
OG00243.5
OG00331.8
OG001
Part B Abemaciclib: HR+, HER2- Breast Cancer
Abemaciclib 200 mg was administered orally once every 12 hours on days 1-21 of a 21-day cycle when administered as a single agent or in combination with endocrine therapy (ET).
Participants may continue to receive treatment until discontinuation criteria are met.
OG002
Part D Abemaciclib: NSCLC
Abemaciclib 200 mg was administered orally once every 12 hours on days 1-21 of a 21-day cycle. Participants with NSCLC receiving concurrent gemcitabine or pemetrexed, 150 mg abemaciclib was 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.
OG003
Part E Abemaciclib: Melanoma
Abemaciclib 200 mg was administered 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.
Units
Counts
Participants
OG00023
OG00152
OG00223
OG00322
Title
Denominators
Categories
Title
Measurements
OG00013.0
OG00126.9
OG00226.1
OG0039.1
OG002
Part D Abemaciclib: NSCLC
Abemaciclib 200 mg was administered orally once every 12 hours on days 1-21 of a 21-day cycle. Participants with NSCLC receiving concurrent gemcitabine or pemetrexed, 150 mg abemaciclib was 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.
OG003
Part E Abemaciclib: Melanoma
Abemaciclib 200 mg was administered 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.
Units
Counts
Participants
OG00027
OG00158
OG00228
OG00323
Title
Denominators
Categories
Title
Measurements
OG00010.06(4.21 to 14.30)
OG00113.38(9.60 to 20.84)
OG0027.13(3.65 to 9.37)
OG0032.93(1.22 to 4.31)
Abemaciclib 200 mg was administered orally once every 12 hours on days 1-21 of a 21-day cycle when administered as a single agent or in combination with endocrine therapy (ET).
Participants may continue to receive treatment until discontinuation criteria are met.
OG002
Part D Abemaciclib: NSCLC
Abemaciclib 200 mg was administered orally once every 12 hours on days 1-21 of a 21-day cycle. Participants with NSCLC receiving concurrent gemcitabine or pemetrexed, 150 mg abemaciclib was 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.
OG003
Part E Abemaciclib: Melanoma
Abemaciclib 200 mg was administered 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.
Units
Counts
Participants
OG00027
OG00158
OG00228
OG00323
Title
Denominators
Categories
Title
Measurements
OG0000
OG0011.7
OG0023.6
OG0030
Abemaciclib 200 mg was administered orally once every 12 hours on days 1-21 of a 21-day cycle when administered as a single agent or in combination with endocrine therapy (ET).
Participants may continue to receive treatment until discontinuation criteria are met.
OG002
Part D Abemaciclib: NSCLC
Abemaciclib 200 mg was administered orally once every 12 hours on days 1-21 of a 21-day cycle. Participants with NSCLC receiving concurrent gemcitabine or pemetrexed, 150 mg abemaciclib was 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.
OG003
Part E Abemaciclib: Melanoma
Abemaciclib 200 mg was administered 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.
Units
Counts
Participants
OG00027
OG00158
OG00228
OG00323
Title
Denominators
Categories
Title
Measurements
OG00040.7
OG00151.7
OG00239.3
OG00326.1
OG002
Part D Abemaciclib: NSCLC
Abemaciclib 200 mg was administered orally once every 12 hours on days 1-21 of a 21-day cycle. Participants with NSCLC receiving concurrent gemcitabine or pemetrexed, 150 mg abemaciclib was 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.
OG003
Part E Abemaciclib: Melanoma
Abemaciclib 200 mg was administered 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.
Units
Counts
Participants
OG00027
OG00158
OG00228
OG00323
Title
Denominators
Categories
Title
Measurements
OG0002.07(1.35 to 3.32)
OG0014.41(2.60 to 5.46)
OG0021.45(1.35 to 2.76)
OG0031.22(1.02 to 1.55)
Abemaciclib 200 mg was administered orally once every 12 hours on days 1-21 of a 21-day cycle when administered as a single agent or in combination with endocrine therapy (ET).
Participants may continue to receive treatment until discontinuation criteria are met.
OG002
Part D Abemaciclib: NSCLC
Abemaciclib 200 mg was administered orally once every 12 hours on days 1-21 of a 21-day cycle. Participants with NSCLC receiving concurrent gemcitabine or pemetrexed, 150 mg abemaciclib was 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.
OG003
Part E Abemaciclib: Melanoma
Abemaciclib 200 mg was administered 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.
Units
Counts
Participants
OG00011
OG00135
OG00210
OG0037
Title
Denominators
Categories
mean core symptom severity
ParticipantsOG00011
ParticipantsOG00135
ParticipantsOG00210
ParticipantsOG0037
Title
Measurements
OG000-0.98± 0.86
OG001-0.17± 0.99
OG002-0.38± 1.19
OG003
mean brain tumor symptom severity
ParticipantsOG00011
ParticipantsOG00135
ParticipantsOG0029
ParticipantsOG0037
mean focal neurologic deficit symptom severity
ParticipantsOG00011
ParticipantsOG00135
ParticipantsOG0029
ParticipantsOG0037
mean generalized disease status
ParticipantsOG00011
ParticipantsOG00135
ParticipantsOG0029
ParticipantsOG0037
mean gastrointestinal symptom
ParticipantsOG00010
ParticipantsOG00134
ParticipantsOG0028
ParticipantsOG0037
OG003
Part D 200 mg Abemaciclib: NSCLC
Participants with NSCLC received 200 mg abemaciclib given orally once every 12 hours on days 1-21 of a 21-day cycle.
OG004
Part E 200 mg Abemaciclib: Melanoma
Participants with melanoma received 200 mg abemaciclib given orally once every 12 hours on days 1-21 of a 21-day cycle.
OG005
Part F 200 mg Abemaciclib: HR+ Breast Cancer, NSCLC, Melanoma
Participants with HR+ (either HER2+ or HER2-) breast cancer, NSCLC, or melanoma and leptomeningeal metastases received 200 mg abemaciclib given orally once every 12 hours on days 1-21 of a 21-day cycle.
Units
Counts
Participants
OG0003
OG00112
OG0021
OG0035
OG0042
OG0054
Title
Denominators
Categories
Abemaciclib
ParticipantsOG0003
ParticipantsOG00112
ParticipantsOG0021
ParticipantsOG0035
ParticipantsOG0042
ParticipantsOG0054
Title
Measurements
OG000133± 13.4
OG001120± 186
OG002NA± NAN=1, Geometric mean and coefficient of variation (CV) were not calculated. Individual value reported: 256 ng/mL
OG003
LSN2839567 (M2)
ParticipantsOG0003
ParticipantsOG00112
ParticipantsOG0021
ParticipantsOG0035
LSN3106726 (M20)
ParticipantsOG0003
ParticipantsOG00112
ParticipantsOG0021
ParticipantsOG0035
LSN3106729 (M18)
ParticipantsOG0003
ParticipantsOG00111
ParticipantsOG0021
ParticipantsOG0035
0 events
0 affected
28 at risk
EG0040 events0 affected23 at risk
EG0050 events0 affected17 at risk
0 events
0 affected
28 at risk
EG0041 events1 affected23 at risk
EG0050 events0 affected17 at risk
1 events
1 affected
28 at risk
EG0040 events0 affected23 at risk
EG0050 events0 affected17 at risk
1 events
1 affected
28 at risk
EG0040 events0 affected23 at risk
EG0050 events0 affected17 at risk
0 events
0 affected
28 at risk
EG0040 events0 affected23 at risk
EG0050 events0 affected17 at risk
0 events
0 affected
28 at risk
EG0040 events0 affected23 at risk
EG0050 events0 affected17 at risk
0 events
0 affected
28 at risk
EG0040 events0 affected23 at risk
EG0050 events0 affected17 at risk
1 events
1 affected
28 at risk
EG0040 events0 affected23 at risk
EG0050 events0 affected17 at risk
1 events
1 affected
28 at risk
EG0040 events0 affected23 at risk
EG0050 events0 affected17 at risk
0 events
0 affected
28 at risk
EG0040 events0 affected23 at risk
EG0051 events1 affected17 at risk
0 events
0 affected
28 at risk
EG0040 events0 affected23 at risk
EG0050 events0 affected17 at risk
0 events
0 affected
28 at risk
EG0040 events0 affected23 at risk
EG0051 events1 affected17 at risk
0 events
0 affected
28 at risk
EG0040 events0 affected23 at risk
EG0052 events1 affected17 at risk
0 events
0 affected
28 at risk
EG0040 events0 affected23 at risk
EG0050 events0 affected17 at risk
0 events
0 affected
28 at risk
EG0040 events0 affected23 at risk
EG0052 events1 affected17 at risk
0 events
0 affected
28 at risk
EG0040 events0 affected23 at risk
EG0050 events0 affected17 at risk
1 events
1 affected
28 at risk
EG0040 events0 affected23 at risk
EG0050 events0 affected17 at risk
1 events
1 affected
28 at risk
EG0040 events0 affected23 at risk
EG0050 events0 affected17 at risk
3 events
3 affected
28 at risk
EG0040 events0 affected23 at risk
EG0051 events1 affected17 at risk
0 events
0 affected
28 at risk
EG0040 events0 affected23 at risk
EG0050 events0 affected17 at risk
0 events
0 affected
28 at risk
EG0040 events0 affected23 at risk
EG0051 events1 affected17 at risk
1 events
1 affected
28 at risk
EG0040 events0 affected23 at risk
EG0050 events0 affected17 at risk
1 events
1 affected
28 at risk
EG0041 events1 affected23 at risk
EG0050 events0 affected17 at risk
0 events
0 affected
28 at risk
EG0040 events0 affected23 at risk
EG0050 events0 affected17 at risk
0 events
0 affected
28 at risk
EG0040 events0 affected23 at risk
EG0050 events0 affected17 at risk
0 events
0 affected
28 at risk
EG0042 events2 affected23 at risk
EG0051 events1 affected17 at risk
0 events
0 affected
28 at risk
EG0040 events0 affected23 at risk
EG0050 events0 affected17 at risk
0 events
0 affected
28 at risk
EG0040 events0 affected23 at risk
EG0051 events1 affected17 at risk
0 events
0 affected
28 at risk
EG0040 events0 affected23 at risk
EG0050 events0 affected17 at risk
0 events
0 affected
28 at risk
EG0040 events0 affected23 at risk
EG0050 events0 affected17 at risk
0 events
0 affected
28 at risk
EG0040 events0 affected23 at risk
EG0051 events1 affected17 at risk
1 events
1 affected
28 at risk
EG0040 events0 affected23 at risk
EG0050 events0 affected17 at risk
0 events
0 affected
28 at risk
EG0040 events0 affected23 at risk
EG0050 events0 affected17 at risk
1 events
1 affected
28 at risk
EG0040 events0 affected23 at risk
EG0050 events0 affected17 at risk
0 events
0 affected
28 at risk
EG0040 events0 affected23 at risk
EG0050 events0 affected17 at risk
1 events
1 affected
28 at risk
EG0041 events1 affected23 at risk
EG0053 events2 affected17 at risk
0 events
0 affected
28 at risk
EG0040 events0 affected23 at risk
EG0051 events1 affected17 at risk
0 events
0 affected
28 at risk
EG0041 events1 affected23 at risk
EG0050 events0 affected17 at risk
0 events
0 affected
28 at risk
EG0040 events0 affected23 at risk
EG0051 events1 affected17 at risk
1 events
1 affected
28 at risk
EG0040 events0 affected23 at risk
EG0050 events0 affected17 at risk
1 events
1 affected
28 at risk
EG0040 events0 affected23 at risk
EG0050 events0 affected17 at risk
0 events
0 affected
28 at risk
EG0040 events0 affected23 at risk
EG0050 events0 affected17 at risk
0 events
0 affected
28 at risk
EG0040 events0 affected23 at risk
EG0050 events0 affected17 at risk
0 events
0 affected
28 at risk
EG0040 events0 affected23 at risk
EG0051 events1 affected17 at risk
1 events
1 affected
28 at risk
EG0040 events0 affected23 at risk
EG0050 events0 affected17 at risk
0 events
0 affected
28 at risk
EG0040 events0 affected23 at risk
EG0050 events0 affected17 at risk
0 events
0 affected
28 at risk
EG0040 events0 affected23 at risk
EG0050 events0 affected17 at risk
0 events
0 affected
28 at risk
EG0040 events0 affected23 at risk
EG0050 events0 affected17 at risk
0 events
0 affected
28 at risk
EG0040 events0 affected23 at risk
EG0051 events1 affected17 at risk
0 events
0 affected
28 at risk
EG0040 events0 affected23 at risk
EG0050 events0 affected17 at risk
0 events
0 affected
28 at risk
EG0040 events0 affected23 at risk
EG0050 events0 affected17 at risk
6 events
4 affected
28 at risk
EG0045 events3 affected23 at risk
EG0053 events3 affected17 at risk
7 events
4 affected
28 at risk
EG0042 events1 affected23 at risk
EG0053 events3 affected17 at risk
9 events
7 affected
28 at risk
EG0048 events5 affected23 at risk
EG0052 events2 affected17 at risk
11 events
8 affected
28 at risk
EG0044 events3 affected23 at risk
EG0053 events3 affected17 at risk
0 events
0 affected
28 at risk
EG0040 events0 affected23 at risk
EG0051 events1 affected17 at risk
0 events
0 affected
28 at risk
EG0040 events0 affected23 at risk
EG0051 events1 affected17 at risk
0 events
0 affected
28 at risk
EG0040 events0 affected23 at risk
EG0051 events1 affected17 at risk
0 events
0 affected
28 at risk
EG0040 events0 affected23 at risk
EG0050 events0 affected17 at risk
2 events
1 affected
28 at risk
EG0040 events0 affected23 at risk
EG0051 events1 affected17 at risk
3 events
3 affected
28 at risk
EG0041 events1 affected23 at risk
EG0052 events2 affected17 at risk
0 events
0 affected
28 at risk
EG0040 events0 affected23 at risk
EG0052 events2 affected17 at risk
2 events
2 affected
28 at risk
EG0045 events5 affected23 at risk
EG0054 events4 affected17 at risk
0 events
0 affected
28 at risk
EG0040 events0 affected23 at risk
EG0051 events1 affected17 at risk
0 events
0 affected
28 at risk
EG0040 events0 affected23 at risk
EG0050 events0 affected17 at risk
7 events
7 affected
28 at risk
EG0042 events2 affected23 at risk
EG0053 events3 affected17 at risk
21 events
15 affected
28 at risk
EG0046 events5 affected23 at risk
EG0056 events6 affected17 at risk
2 events
2 affected
28 at risk
EG0041 events1 affected23 at risk
EG0051 events1 affected17 at risk
0 events
0 affected
28 at risk
EG0040 events0 affected23 at risk
EG0051 events1 affected17 at risk
0 events
0 affected
28 at risk
EG0040 events0 affected23 at risk
EG0051 events1 affected17 at risk
0 events
0 affected
28 at risk
EG0040 events0 affected23 at risk
EG0050 events0 affected17 at risk
0 events
0 affected
28 at risk
EG0040 events0 affected23 at risk
EG0051 events1 affected17 at risk
10 events
8 affected
28 at risk
EG0041 events1 affected23 at risk
EG00510 events7 affected17 at risk
0 events
0 affected
28 at risk
EG0040 events0 affected23 at risk
EG0051 events1 affected17 at risk
0 events
0 affected
28 at risk
EG0040 events0 affected23 at risk
EG0051 events1 affected17 at risk
4 events
4 affected
28 at risk
EG0041 events1 affected23 at risk
EG0056 events5 affected17 at risk
0 events
0 affected
28 at risk
EG0040 events0 affected23 at risk
EG0050 events0 affected17 at risk
16 events
11 affected
28 at risk
EG0044 events4 affected23 at risk
EG0059 events9 affected17 at risk
2 events
1 affected
28 at risk
EG0040 events0 affected23 at risk
EG0050 events0 affected17 at risk
0 events
0 affected
28 at risk
EG0042 events2 affected23 at risk
EG0050 events0 affected17 at risk
0 events
0 affected
28 at risk
EG0041 events1 affected23 at risk
EG0050 events0 affected17 at risk
0 events
0 affected
28 at risk
EG0040 events0 affected23 at risk
EG0050 events0 affected17 at risk
1 events
1 affected
28 at risk
EG0040 events0 affected23 at risk
EG0050 events0 affected17 at risk
0 events
0 affected
28 at risk
EG0040 events0 affected23 at risk
EG0050 events0 affected17 at risk
1 events
1 affected
28 at risk
EG0043 events3 affected23 at risk
EG0051 events1 affected17 at risk
1 events
1 affected
28 at risk
EG0040 events0 affected23 at risk
EG0052 events2 affected17 at risk
3 events
2 affected
28 at risk
EG0040 events0 affected23 at risk
EG0050 events0 affected17 at risk
0 events
0 affected
28 at risk
EG0040 events0 affected23 at risk
EG0051 events1 affected17 at risk
0 events
0 affected
28 at risk
EG0040 events0 affected23 at risk
EG0050 events0 affected17 at risk
2 events
2 affected
28 at risk
EG0040 events0 affected23 at risk
EG0050 events0 affected17 at risk
0 events
0 affected
28 at risk
EG0040 events0 affected23 at risk
EG0051 events1 affected17 at risk
0 events
0 affected
28 at risk
EG0040 events0 affected23 at risk
EG0050 events0 affected17 at risk
3 events
3 affected
28 at risk
EG0040 events0 affected23 at risk
EG0050 events0 affected17 at risk
0 events
0 affected
28 at risk
EG0040 events0 affected23 at risk
EG0051 events1 affected17 at risk
0 events
0 affected
28 at risk
EG0040 events0 affected23 at risk
EG0050 events0 affected17 at risk
0 events
0 affected
28 at risk
EG0040 events0 affected23 at risk
EG0051 events1 affected17 at risk
2 events
2 affected
28 at risk
EG0040 events0 affected23 at risk
EG0050 events0 affected17 at risk
4 events
2 affected
28 at risk
EG0042 events2 affected23 at risk
EG0052 events2 affected17 at risk
2 events
2 affected
28 at risk
EG0044 events4 affected23 at risk
EG0053 events2 affected17 at risk
5 events
2 affected
28 at risk
EG0041 events1 affected23 at risk
EG0051 events1 affected17 at risk
0 events
0 affected
28 at risk
EG0040 events0 affected23 at risk
EG0050 events0 affected17 at risk
4 events
2 affected
28 at risk
EG0043 events2 affected23 at risk
EG0052 events1 affected17 at risk
0 events
0 affected
28 at risk
EG0040 events0 affected23 at risk
EG0050 events0 affected17 at risk
0 events
0 affected
28 at risk
EG0040 events0 affected23 at risk
EG0051 events1 affected17 at risk
5 events
4 affected
28 at risk
EG0042 events1 affected23 at risk
EG0052 events2 affected17 at risk
0 events
0 affected
28 at risk
EG0040 events0 affected23 at risk
EG0052 events2 affected17 at risk
10 events
7 affected
28 at risk
EG0042 events2 affected23 at risk
EG0052 events2 affected17 at risk
4 events
3 affected
28 at risk
EG0041 events1 affected23 at risk
EG0050 events0 affected17 at risk
2 events
2 affected
28 at risk
EG0040 events0 affected23 at risk
EG0051 events1 affected17 at risk
0 events
0 affected
28 at risk
EG0040 events0 affected23 at risk
EG0050 events0 affected17 at risk
0 events
0 affected
28 at risk
EG0040 events0 affected23 at risk
EG0051 events1 affected17 at risk
1 events
1 affected
28 at risk
EG0040 events0 affected23 at risk
EG0050 events0 affected17 at risk
0 events
0 affected
28 at risk
EG0040 events0 affected23 at risk
EG0052 events2 affected17 at risk
0 events
0 affected
28 at risk
EG0040 events0 affected23 at risk
EG0053 events3 affected17 at risk
2 events
2 affected
28 at risk
EG0041 events1 affected23 at risk
EG0052 events2 affected17 at risk
1 events
1 affected
28 at risk
EG0041 events1 affected23 at risk
EG0053 events3 affected17 at risk
0 events
0 affected
28 at risk
EG0041 events1 affected23 at risk
EG0050 events0 affected17 at risk
3 events
3 affected
28 at risk
EG0041 events1 affected23 at risk
EG0052 events1 affected17 at risk
0 events
0 affected
28 at risk
EG0043 events2 affected23 at risk
EG0050 events0 affected17 at risk
0 events
0 affected
28 at risk
EG0040 events0 affected23 at risk
EG0050 events0 affected17 at risk
0 events
0 affected
28 at risk
EG0040 events0 affected23 at risk
EG0050 events0 affected17 at risk
2 events
2 affected
28 at risk
EG0042 events2 affected23 at risk
EG0054 events4 affected17 at risk
0 events
0 affected
28 at risk
EG0043 events3 affected23 at risk
EG0050 events0 affected17 at risk
0 events
0 affected
28 at risk
EG0043 events3 affected23 at risk
EG0050 events0 affected17 at risk
0 events
0 affected
28 at risk
EG0040 events0 affected23 at risk
EG0051 events1 affected17 at risk
1 events
1 affected
28 at risk
EG0040 events0 affected23 at risk
EG0050 events0 affected17 at risk
0 events
0 affected
28 at risk
EG0040 events0 affected23 at risk
EG0050 events0 affected17 at risk
0 events
0 affected
28 at risk
EG0040 events0 affected23 at risk
EG0050 events0 affected17 at risk
0 events
0 affected
28 at risk
EG0040 events0 affected23 at risk
EG0051 events1 affected17 at risk
1 events
1 affected
28 at risk
EG0040 events0 affected23 at risk
EG0051 events1 affected17 at risk
2 events
2 affected
28 at risk
EG0041 events1 affected23 at risk
EG0050 events0 affected17 at risk
0 events
0 affected
28 at risk
EG0040 events0 affected23 at risk
EG0051 events1 affected17 at risk
4 events
4 affected
28 at risk
EG0043 events2 affected23 at risk
EG0053 events3 affected17 at risk
0 events
0 affected
28 at risk
EG0040 events0 affected23 at risk
EG0050 events0 affected17 at risk
1 events
1 affected
28 at risk
EG0042 events1 affected23 at risk
EG0050 events0 affected17 at risk
0 events
0 affected
28 at risk
EG0040 events0 affected23 at risk
EG0051 events1 affected17 at risk
0 events
0 affected
28 at risk
EG0040 events0 affected23 at risk
EG0051 events1 affected17 at risk
2 events
1 affected
28 at risk
EG0043 events3 affected23 at risk
EG0050 events0 affected17 at risk
1 events
1 affected
28 at risk
EG0040 events0 affected23 at risk
EG0051 events1 affected17 at risk
1 events
1 affected
28 at risk
EG0040 events0 affected23 at risk
EG0050 events0 affected17 at risk
0 events
0 affected
28 at risk
EG0042 events2 affected23 at risk
EG0050 events0 affected17 at risk
2 events
2 affected
28 at risk
EG0041 events1 affected23 at risk
EG0050 events0 affected17 at risk
8 events
5 affected
28 at risk
EG0040 events0 affected23 at risk
EG0051 events1 affected17 at risk
1 events
1 affected
28 at risk
EG0040 events0 affected23 at risk
EG0050 events0 affected17 at risk
1 events
1 affected
28 at risk
EG0041 events1 affected23 at risk
EG0050 events0 affected17 at risk
2 events
2 affected
28 at risk
EG0041 events1 affected23 at risk
EG0050 events0 affected17 at risk
0 events
0 affected
28 at risk
EG0040 events0 affected23 at risk
EG0050 events0 affected17 at risk
0 events
0 affected
28 at risk
EG0040 events0 affected23 at risk
EG0051 events1 affected17 at risk
0 events
0 affected
28 at risk
EG0040 events0 affected23 at risk
EG0051 events1 affected17 at risk
0 events
0 affected
28 at risk
EG0040 events0 affected23 at risk
EG0050 events0 affected17 at risk
0 events
0 affected
28 at risk
EG0040 events0 affected23 at risk
EG0051 events1 affected17 at risk
5 events
5 affected
28 at risk
EG0040 events0 affected23 at risk
EG0052 events2 affected17 at risk
2 events
2 affected
28 at risk
EG0040 events0 affected23 at risk
EG0050 events0 affected17 at risk
0 events
0 affected
28 at risk
EG0040 events0 affected23 at risk
EG0051 events1 affected17 at risk
1 events
1 affected
28 at risk
EG0040 events0 affected23 at risk
EG0052 events1 affected17 at risk
0 events
0 affected
28 at risk
EG0040 events0 affected23 at risk
EG0051 events1 affected17 at risk
0 events
0 affected
28 at risk
EG0040 events0 affected23 at risk
EG0050 events0 affected17 at risk
2 events
2 affected
28 at risk
EG0041 events1 affected23 at risk
EG0050 events0 affected17 at risk
0 events
0 affected
28 at risk
EG0040 events0 affected23 at risk
EG0051 events1 affected17 at risk
2 events
1 affected
28 at risk
EG0040 events0 affected23 at risk
EG0050 events0 affected17 at risk
0 events
0 affected
28 at risk
EG0040 events0 affected23 at risk
EG0051 events1 affected17 at risk
0 events
0 affected
28 at risk
EG0040 events0 affected23 at risk
EG0050 events0 affected17 at risk
1 events
1 affected
28 at risk
EG0040 events0 affected23 at risk
EG0051 events1 affected17 at risk
31.8
68.2
0
-0.53
± 0.62
Title
Measurements
OG000-0.47± 0.57
OG001-0.29± 1.05
OG002-0.10± 1.22
OG0030.31± 1.11
Title
Measurements
OG000-0.84± 0.92
OG001-0.36± 1.23
OG002-0.44± 0.58
OG0030.54± 1.16
Title
Measurements
OG000-0.47± 1.03
OG0010± 1.39
OG0020.28± 1.51
OG0030.01± 0.89
Title
Measurements
OG000-1.35± 2.11
OG0010.40± 1.91
OG0021.00± 1.46
OG0030± 0.29
306
± 33.5
OG004NA± NAN=2, Geometric mean and CV were not calculated. Individual values reported: 99.7 ng/mL and 222 ng/mL
OG005142± 80.0
Participants
OG004
2
ParticipantsOG0054
Title
Measurements
OG00072.6± 8.23
OG00177.3± 121
OG002NA± NAN=1, Geometric mean and CV were not calculated. Individual value reported: 98.8 ng/mL
OG003100± 77.5
OG004NA± NAN=2, Geometric mean and CV were not calculated. Individual values reported: 61.6 ng/mL and 90.7 ng/mL
OG00568.5± 150
ParticipantsOG0042
ParticipantsOG0054
Title
Measurements
OG000158± 25.0
OG001133± 160
OG002NA± NAN=1, Geometric mean and CV were not calculated. Individual value reported: 181 ng/mL
OG003203± 43.3
OG004NA± NAN=2, Geometric mean and CV were not calculated. Individual values reported: 109 ng/mL and 172 ng/mL
OG005122± 137
ParticipantsOG0042
ParticipantsOG0054
Title
Measurements
OG00036.8± 39.3
OG00142.4± 85.6
OG002NA± NAN=1, Geometric mean and CV were not calculated. Individual value reported: 28.2 ng/mL
OG00328.9± 108
OG004NA± NAN=2, Geometric mean and CV were not calculated. Individual values reported: 22.2 ng/mL and 44.2 ng/mL