Please note that the copy function is not enabled for this field.
If you wish to
modify
existing outcomes, please copy and paste the current outcome text into the Update field.
LOGIN
CREATE ACCOUNT
MY TRIALS
LOGIN
CREATE ACCOUNT
MY TRIALS
REGISTER TRIAL
FAQs
HINTS AND TIPS
DEFINITIONS
Register a trial
The ANZCTR website will be unavailable from 1pm until 3pm (AEDT) on Wednesday the 30th of October for website maintenance. Please be sure to log out of the system in order to avoid any loss of data.
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this
information for consumers
Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT02308020
Registration number
NCT02308020
Ethics application status
Date submitted
2/12/2014
Date registered
4/12/2014
Titles & IDs
Public title
A Study of Abemaciclib (LY2835219) in Participants With Breast Cancer, Non-small Cell Lung Cancer, or Melanoma That Has Spread to the Brain
Query!
Scientific 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
Query!
Secondary ID [1]
0
0
I3Y-MC-JPBO
Query!
Secondary ID [2]
0
0
15450
Query!
Universal Trial Number (UTN)
Query!
Trial acronym
Query!
Linked study record
Query!
Health condition
Health condition(s) or problem(s) studied:
Breast Cancer
0
0
Query!
Non-small Cell Lung Cancer
0
0
Query!
Melanoma
0
0
Query!
Brain Metastases
0
0
Query!
Condition category
Condition code
Cancer
0
0
0
0
Query!
Breast
Query!
Cancer
0
0
0
0
Query!
Lung - Mesothelioma
Query!
Cancer
0
0
0
0
Query!
Lung - Non small cell
Query!
Cancer
0
0
0
0
Query!
Lung - Small cell
Query!
Cancer
0
0
0
0
Query!
Malignant melanoma
Query!
Cancer
0
0
0
0
Query!
Brain
Query!
Intervention/exposure
Study type
Interventional(has expanded access)
Query!
Description of intervention(s) / exposure
Treatment: Drugs - Abemaciclib
Experimental: Part A Abemaciclib: 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+), 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.
Experimental: 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 participants in combination with endocrine therapy (ET).
Participants may continue to receive treatment until discontinuation criteria are met.
Experimental: 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.
Experimental: 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.
Experimental: 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.
Experimental: 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.
Treatment: Drugs: Abemaciclib
Administered orally
Query!
Intervention code [1]
0
0
Treatment: Drugs
Query!
Comparator / control treatment
Query!
Control group
Query!
Outcomes
Primary outcome [1]
0
0
Percentage of Participants Achieving Complete Response (CR) or Partial Response (PR): Objective Intracranial Response Rate (OIRR)
Query!
Assessment method [1]
0
0
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).
Query!
Timepoint [1]
0
0
Baseline to Objective Disease Progression (Up to 36 Months)
Query!
Secondary outcome [1]
0
0
Percentage of Participants With CR, PR, Stable Disease (SD), Progressive Disease (PD), or Not Evaluable (NE): Best Overall Intracranial Response (BOIR)
Query!
Assessment method [1]
0
0
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).
Query!
Timepoint [1]
0
0
Baseline to Earliest Objective Progression or Start of New Anticancer Therapy (Up to 36 Months)
Query!
Secondary outcome [2]
0
0
Duration of CR or PR: Duration of Intracranial Response (DOIR)
Query!
Assessment method [2]
0
0
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.
Query!
Timepoint [2]
0
0
Date of CR or PR to Date of Objective Disease Progression or Death from Any Cause (Up to 36 Months)
Query!
Secondary outcome [3]
0
0
Percentage of Participants With Best Overall Intracranial Response (BOIR) of CR, PR, or SD: Intracranial Disease Control Rate (IDCR)
Query!
Assessment method [3]
0
0
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.
Query!
Timepoint [3]
0
0
Baseline to Disease Progression or Start of New Anticancer Therapy (Up to 36 Months)
Query!
Secondary outcome [4]
0
0
Percentage of Participants With BOIR of CR, PR, or SD With Duration of SD for at Least 6 Months: Intracranial Clinical Benefit Rate (ICBR)
Query!
Assessment method [4]
0
0
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.
Query!
Timepoint [4]
0
0
Baseline to Disease Progression or Start of New Anticancer Therapy (Up to 36 Months)
Query!
Secondary outcome [5]
0
0
Overall Survival (OS)
Query!
Assessment method [5]
0
0
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.
Query!
Timepoint [5]
0
0
Baseline to the Date of Death from Any Cause (Up to 5 Years)
Query!
Secondary outcome [6]
0
0
Percentage of Participants With a Best Response of CR or PR: Extracranial Objective Response Rate (EORR)
Query!
Assessment method [6]
0
0
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.
Query!
Timepoint [6]
0
0
Baseline to Disease Progression (Up to 36 Months)
Query!
Secondary outcome [7]
0
0
Percentage of Participants With a Best Overall Response of CR, PR, or SD: Extracranial Disease Control Rate (EDCR)
Query!
Assessment method [7]
0
0
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.
Query!
Timepoint [7]
0
0
Baseline to Disease Progression or Start of New Anticancer Therapy (Up to 36 Months)
Query!
Secondary outcome [8]
0
0
Progression Free Survival (PFS) Bi-compartmental
Query!
Assessment method [8]
0
0
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.
Query!
Timepoint [8]
0
0
Baseline to Objective Disease Progression or Death from Any Cause (Up to 36 Months)
Query!
Secondary outcome [9]
0
0
Change From Baseline in Neurologic Symptoms on the MD Anderson Inventory-Brain Tumor (MDASI-BT) Subscale
Query!
Assessment method [9]
0
0
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.
Query!
Timepoint [9]
0
0
Baseline, Cycle 3 (Up to 63 Days)
Query!
Secondary outcome [10]
0
0
Pharmacokinetics (PK): Steady State Minimum Concentration (Cmin) of Abemaciclib and Its Metabolites LSN2839567 (M2), LSN3106726 (M20), and LSN3106729 (M18)
Query!
Assessment method [10]
0
0
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.
Query!
Timepoint [10]
0
0
Parts A, B, D, E, F, Cycle 3, Day 1: Predose; Part C, Cycle 4, Day 1: Predose
Query!
Eligibility
Key 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.
Query!
Minimum age
18
Years
Query!
Query!
Maximum age
No limit
Query!
Query!
Sex
Both males and females
Query!
Can healthy volunteers participate?
No
Query!
Key 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.
Query!
Study design
Purpose of the study
Treatment
Query!
Allocation to intervention
Non-randomised trial
Query!
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Query!
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Query!
Masking / blinding
Open (masking not used)
Query!
Who is / are masked / blinded?
Query!
Query!
Query!
Query!
Intervention assignment
Single group
Query!
Other design features
Query!
Phase
Phase 2
Query!
Type of endpoint/s
Query!
Statistical methods / analysis
Query!
Recruitment
Recruitment status
Completed
Query!
Data analysis
Query!
Reason for early stopping/withdrawal
Query!
Other reasons
Query!
Date of first participant enrolment
Anticipated
Query!
Actual
20/04/2015
Query!
Date of last participant enrolment
Anticipated
Query!
Actual
Query!
Date of last data collection
Anticipated
Query!
Actual
8/11/2019
Query!
Sample size
Target
Query!
Accrual to date
Query!
Final
162
Query!
Recruitment in Australia
Recruitment state(s)
Query!
Recruitment hospital [1]
0
0
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
Query!
Recruitment hospital [2]
0
0
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
Query!
Recruitment hospital [3]
0
0
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
Query!
Recruitment hospital [4]
0
0
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
Query!
Recruitment postcode(s) [1]
0
0
6009 - Nedlands
Query!
Recruitment postcode(s) [2]
0
0
2298 - Newcastle
Query!
Recruitment postcode(s) [3]
0
0
4215 - Southport
Query!
Recruitment postcode(s) [4]
0
0
4102 - Woolloongabba
Query!
Recruitment outside Australia
Country [1]
0
0
United States of America
Query!
State/province [1]
0
0
California
Query!
Country [2]
0
0
United States of America
Query!
State/province [2]
0
0
Colorado
Query!
Country [3]
0
0
United States of America
Query!
State/province [3]
0
0
District of Columbia
Query!
Country [4]
0
0
United States of America
Query!
State/province [4]
0
0
Florida
Query!
Country [5]
0
0
United States of America
Query!
State/province [5]
0
0
Hawaii
Query!
Country [6]
0
0
United States of America
Query!
State/province [6]
0
0
Kentucky
Query!
Country [7]
0
0
United States of America
Query!
State/province [7]
0
0
Massachusetts
Query!
Country [8]
0
0
United States of America
Query!
State/province [8]
0
0
Michigan
Query!
Country [9]
0
0
United States of America
Query!
State/province [9]
0
0
Missouri
Query!
Country [10]
0
0
United States of America
Query!
State/province [10]
0
0
New York
Query!
Country [11]
0
0
United States of America
Query!
State/province [11]
0
0
North Carolina
Query!
Country [12]
0
0
United States of America
Query!
State/province [12]
0
0
Oregon
Query!
Country [13]
0
0
United States of America
Query!
State/province [13]
0
0
Tennessee
Query!
Country [14]
0
0
United States of America
Query!
State/province [14]
0
0
Texas
Query!
Country [15]
0
0
Austria
Query!
State/province [15]
0
0
Wien
Query!
Country [16]
0
0
Belgium
Query!
State/province [16]
0
0
Brussel
Query!
Country [17]
0
0
Belgium
Query!
State/province [17]
0
0
Charleroi
Query!
Country [18]
0
0
Belgium
Query!
State/province [18]
0
0
Leuven
Query!
Country [19]
0
0
Belgium
Query!
State/province [19]
0
0
Liege
Query!
Country [20]
0
0
Canada
Query!
State/province [20]
0
0
Ottawa
Query!
Country [21]
0
0
France
Query!
State/province [21]
0
0
Lille Cedex
Query!
Country [22]
0
0
France
Query!
State/province [22]
0
0
Lille
Query!
Country [23]
0
0
France
Query!
State/province [23]
0
0
Lyon Cedex 08
Query!
Country [24]
0
0
France
Query!
State/province [24]
0
0
Paris Cedex 05
Query!
Country [25]
0
0
France
Query!
State/province [25]
0
0
Saint-Brieuc
Query!
Country [26]
0
0
France
Query!
State/province [26]
0
0
Toulouse cedex 9
Query!
Country [27]
0
0
Israel
Query!
State/province [27]
0
0
Jerusalem
Query!
Country [28]
0
0
Israel
Query!
State/province [28]
0
0
Tel Hashomer
Query!
Country [29]
0
0
Italy
Query!
State/province [29]
0
0
Cona
Query!
Country [30]
0
0
Italy
Query!
State/province [30]
0
0
Genova
Query!
Country [31]
0
0
Italy
Query!
State/province [31]
0
0
Padova
Query!
Country [32]
0
0
Italy
Query!
State/province [32]
0
0
Roma
Query!
Country [33]
0
0
Spain
Query!
State/province [33]
0
0
Barcelona
Query!
Country [34]
0
0
Spain
Query!
State/province [34]
0
0
Madrid
Query!
Country [35]
0
0
Spain
Query!
State/province [35]
0
0
Sevilla
Query!
Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Query!
Name
Eli Lilly and Company
Query!
Address
Query!
Country
Query!
Ethics approval
Ethics application status
Query!
Summary
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.
Query!
Trial website
https://clinicaltrials.gov/study/NCT02308020
Query!
Trial related presentations / 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. Erratum In: Clin Cancer Res. 2021 Mar 1;27(5):1582. doi: 10.1158/1078-0432.CCR-21-0193.
Query!
Public notes
Query!
Contacts
Principal investigator
Name
0
0
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)
Query!
Address
0
0
Eli Lilly and Company
Query!
Country
0
0
Query!
Phone
0
0
Query!
Fax
0
0
Query!
Email
0
0
Query!
Contact person for public queries
Name
0
0
Query!
Address
0
0
Query!
Country
0
0
Query!
Phone
0
0
Query!
Fax
0
0
Query!
Email
0
0
Query!
Contact person for scientific queries
Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
Query!
What data in particular will be shared?
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.
Supporting document/s available: Study protocol, Statistical analysis plan (SAP), Clinical study report (CSR)
Query!
When will data be available (start and end dates)?
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.
Query!
Available to whom?
A research proposal must be approved by an independent review panel and researchers must sign a data sharing agreement.
Query!
Available for what types of analyses?
Query!
How or where can data be obtained?
IPD available at link: https://vivli.org/
Query!
What supporting documents are/will be available?
No Supporting Document Provided
Type
Other Details
Attachment
Study protocol
Study Protocol: Protocol
https://cdn.clinicaltrials.gov/large-docs/20/NCT02308020/Prot_000.pdf
Statistical analysis plan
https://cdn.clinicaltrials.gov/large-docs/20/NCT02308020/SAP_001.pdf
Study protocol
Study Protocol: Protocol Amendment (d)
https://cdn.clinicaltrials.gov/large-docs/20/NCT02308020/Prot_002.pdf
Results publications and other study-related documents
No documents have been uploaded by study researchers.
Results not provided in
https://clinicaltrials.gov/study/NCT02308020