Breast CancerPhase 2NCT02308020

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

A Phase 2 study testing Abemaciclib in people with Breast Cancer and Non-small Cell Lung Cancer, run by Eli Lilly and Company at 44 sites in 9 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial 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. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Breast Cancer, Non-small Cell Lung Cancer, Melanoma
What is being tested?: Abemaciclib
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 162 participants
Where: 44 sitesin 9 countries
Study dates: 20 Apr 2015to 8 Nov 2019
Phase: Phase 2
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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.

Show all 16Show fewer

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.

Who cannot join

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.

Trial locations and contacts

44 sites in 9 countries.

Country

City, postcode or hospital

44 sites in 9 countries

United States19 sites

University of Michigan
Ann Arbor, Michigan, 48109
University of Colorado
Aurora, Colorado, 80045
Dana Farber Cancer Institute
Boston, Massachusetts, 02215
University of North Carolina at Chapel Hill
Chapel Hill, North Carolina, 27599
City of Hope National Medical Center
Duarte, California, 91010
Florida Cancer Specialists
Fort Myers, Florida, 33916-2233
Kaiser Permanente Center for Health Research
Honolulu, Hawaii, 96819
University of Texas MD Anderson Cancer Center
Houston, Texas, 77030
University of California - San Diego
La Jolla, California, 92037-0845
James Graham Brown Cancer Center
Louisville, Kentucky, 40202
SMO Sarah Cannon Research Inst.
Nashville, Tennessee, 37203
Tennessee Oncology PLLC
Nashville, Tennessee, 37203
Memorial Sloan Kettering Cancer Center
New York, New York, 10065
Providence Health and Services
Portland, Oregon, 97213
Univ of California San Francisco
San Francisco, California, 94115
John Wayne Cancer Institute
Santa Monica, California, 90404
Washington University Medical Center
St Louis, Missouri, 63110
H Lee Moffitt Cancer Center
Tampa, Florida, 33612-9497
Georgetown University Medical Center
Washington D.C., District of Columbia, 20007

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France6 sites

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
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Lille, 59037
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Lyon, 69373
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Paris, 75248
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Saint-Brieuc, 22027
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Toulouse, 31059

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Australia4 sites

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Nedlands, 6009
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Newcastle, 2298
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Southport, 4215
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Woolloongabba, 4102

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Belgium4 sites

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Brussels, 1000
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Charleroi, 6000
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Leuven, 3000
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Liège, 4000

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Italy4 sites

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Cona, 44124
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Genova, 16132
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Padova, 35128
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Roma, 00128

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Spain3 sites

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Barcelona, 08035
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Madrid, 28034
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Seville, 41013

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Israel2 sites

Hadassah Medical Center - Ein Karem
Jerusalem, 9112001
Sheba Medical Center
Tel HaShomer, 5265601

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Austria1 site

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Vienna, 1090

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Canada1 site

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

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About this study

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

Conditions: Breast Cancer, Non-small Cell Lung Cancer, Melanoma, Brain Metastases
Being tested: Abemaciclib
Medical subject headings: Breast Neoplasms, Carcinoma, Non-Small-Cell Lung, Melanoma, Brain Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

AbemaciclibDrug
Also called LY2835219
Administered orally

Study groups in NCT02308020
Study group	Role	What they receive
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. Receives: 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. Receives: 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. Receives: Drug: Abemaciclib
Part D Abemaciclib: Non-Small Cell Lung Cancer (NSCLC)	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. Receives: 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. Receives: 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. Receives: Drug: Abemaciclib

What is being measured

The primary outcome is the main question the study is designed to answer.

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).
Measured: Baseline to Objective Disease Progression (Up to 36 Months)

Secondary outcomes (10)

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).
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Parts A, B, D, E, F, Cycle 3, Day 1: Predose; Part C, Cycle 4, Day 1: Predose

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

20 Apr 20158 Nov 2019

First posted4 Dec 2014 (estimated)
Study start20 Apr 2015
Primary completion8 Nov 2018
Study completion8 Nov 2019

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Breast CancerStudies of the same condition, open and under way.
More trials run by Eli Lilly and CompanyThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 2
Primary purpose: Treatment
Allocation: Non-randomised
Intervention model: Single group
Masking: None (open label)
Enrolment: 162 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02308020
Sponsor's protocol ID: 15450
Other IDs: I3Y-MC-JPBO, 2014-004010-28, 2014
Status last verified: Dec 2020
First submitted: 2 Dec 2014
Last updated: 19 Dec 2020
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
Individual data sharing: Yes: 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.
Expanded access: Available

Publications

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.
PubMed 32694159

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 19 Dec 2020. Recruitment status is as the sponsor reported it: confirm with the study team.

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
ClinicalTrials.gov ID: NCT02308020
Acronym / sponsor ID: 15450
Conditions: Breast Cancer, Non-small Cell Lung Cancer, Melanoma, Brain Metastases
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 162 participants (actual)
Lead sponsor: Eli Lilly and CompanyIndustry (pharma, biotech, devices)
Study start: 20 Apr 2015 (actual)
Primary completion: 8 Nov 2018 (actual)
Study completion: 8 Nov 2019 (actual)
First posted: 4 Dec 2014 (estimated)
Results: Posted 19 Dec 2019

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Non-randomised
Intervention model: Single group
Masking: None (open label)
Number of arms: 6

Arm	Type	Receives
Part A Abemaciclib: HR+, HER2+ Breast Cancer	Experimental	Drug: AbemaciclibAbemaciclib 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.
Part B Abemaciclib: HR+, HER2- Breast Cancer	Experimental	Drug: AbemaciclibAbemaciclib 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.
Part C Abemaciclib: Surgical Resection	Experimental	Drug: AbemaciclibAbemaciclib 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.
Part D Abemaciclib: Non-Small Cell Lung Cancer (NSCLC)	Experimental	Drug: AbemaciclibAbemaciclib 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.
Part E Abemaciclib: Melanoma	Experimental	Drug: AbemaciclibAbemaciclib 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.
Part F Abemaciclib: HR+ Breast Cancer, NSCLC, or Melanoma	Experimental	Drug: AbemaciclibAbemaciclib 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.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (16 listed)

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.

Key exclusion criteria (8 listed)

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.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
AbemaciclibAlso: LY2835219Administered orally	Drug	Part A Abemaciclib: HR+, HER2+ Breast Cancer, Part B Abemaciclib: HR+, HER2- Breast Cancer, Part C Abemaciclib: Surgical Resection, Part D Abemaciclib: Non-Small Cell Lung Cancer (NSCLC), Part E Abemaciclib: Melanoma, Part F Abemaciclib: HR+ Breast Cancer, NSCLC, or Melanoma

Primary outcome

Percentage of Participants Achieving Complete Response (CR) or Partial Response (PR): Objective Intracranial Response Rate (OIRR)
Time frame: Baseline to Objective Disease Progression (Up to 36 Months)
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).

10 secondary outcomes

Percentage of Participants With CR, PR, Stable Disease (SD), Progressive Disease (PD), or Not Evaluable (NE): Best Overall Intracranial Response (BOIR)
Time frame: Baseline to Earliest Objective Progression or Start of New Anticancer Therapy (Up to 36 Months)
Duration of CR or PR: Duration of Intracranial Response (DOIR)
Time frame: 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)
Time frame: 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)
Time frame: Baseline to Disease Progression or Start of New Anticancer Therapy (Up to 36 Months)
Overall Survival (OS)
Time frame: 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)
Time frame: 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)
Time frame: Baseline to Disease Progression or Start of New Anticancer Therapy (Up to 36 Months)
Progression Free Survival (PFS) Bi-compartmental
Time frame: 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
Time frame: 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)
Time frame: Parts A, B, D, E, F, Cycle 3, Day 1: Predose; Part C, Cycle 4, Day 1: Predose

Results and safety

Results posted to the registry on 19 Dec 2019, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Part A Abemaciclib: Hormone Receptor (HR+) HER2+ Breast Cancer	27	23
Part B Abemaciclib: HR+, HER2- Breast Cancer	58	38
Part C Abemaciclib: Surgical Resection	9	6
Part D Abemaciclib: Non-Small Cell Lung Cancer (NSCLC)	28	24
Part E Abemaciclib: Melanoma	23	19
Part F Abemaciclib: HR+ Breast Cancer, NSCLC, or Melanoma	17	12

Primary outcome: Percentage of Participants Achieving Complete Response (CR) or Partial Response (PR): Objective Intracranial Response Rate (OIRR)

Time frame: Baseline to Objective Disease Progression (Up to 36 Months). Number. Unit: percentage of participants

Measure	Part A Abemaciclib: HR+, HER2+ Breast Cancer n = 23	Part B Abemaciclib: HR+, HER2- Breast Cancer n = 52	Part D Abemaciclib: NSCLC n = 23	Part E Abemaciclib: Melanoma n = 22
Value	0	5.8	0	0

Population analysed: 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.

10 secondary outcomes are reported in the full results.

Adverse events

Time frame: Up to 36 Months. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Part A Abemaciclib: HR+, HER2+ Breast Cancer	6 of 27 (22.2%)	23 of 27 (85.2%)	23 of 27
Part B Abemaciclib: HR+, HER2- Breast Cancer	16 of 58 (27.6%)	55 of 58 (94.8%)	38 of 58
Part C Abemaciclib: Surgical Resection	3 of 9 (33.3%)	8 of 9 (88.9%)	6 of 9
Part D Abemaciclib: NSCLC	8 of 28 (28.6%)	27 of 28 (96.4%)	24 of 28
Part E Abemaciclib: Melanoma	4 of 23 (17.4%)	16 of 23 (69.6%)	19 of 23
Part F: Abemaciclib HR+ Breast Cancer, NSCLC, or Melanoma	7 of 17 (41.2%)	16 of 17 (94.1%)	12 of 17

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 19 Dec 2020.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 32694159Tolaney 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.
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 BrainLink provided by the sponsor.
Individual participant dataSharing planned: Yes. 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.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

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) study director

Eli Lilly and Company

44 sites in 9 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Abemaciclib in people with Breast Cancer and Non-small Cell Lung Cancer, run by Eli Lilly and Company at 44 sites in 9 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 16 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 19 Dec 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 44 sites in United States, France, Australia, Belgium, Italy and 4 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 19 Dec 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Percentage of Participants Achieving Complete Response (CR) or Partial Response (PR): Objective Intracranial Response Rate (OIRR) (time frame: Baseline to Objective Disease Progression (Up to 36 Months)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02308020, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Dec 2020.