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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/show/NCT02308020
Registration number
NCT02308020
Ethics application status
Date submitted
2/12/2014
Date registered
4/12/2014
Date last updated
19/12/2020
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
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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
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Secondary ID [1]
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I3Y-MC-JPBO
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Secondary ID [2]
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15450
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Breast Cancer
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Non-small Cell Lung Cancer
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Melanoma
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Brain Metastases
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Condition category
Condition code
Cancer
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0
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0
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Breast
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Cancer
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0
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0
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Lung - Mesothelioma
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Cancer
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0
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Lung - Non small cell
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Cancer
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Lung - Small cell
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Cancer
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Malignant melanoma
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Cancer
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Brain
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Intervention/exposure
Study type
Interventional(has expanded access)
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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
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Intervention code [1]
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Treatment: Drugs
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Percentage of Participants Achieving Complete Response (CR) or Partial Response (PR): Objective Intracranial Response Rate (OIRR)
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Assessment method [1]
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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).
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Timepoint [1]
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Baseline to Objective Disease Progression (Up to 36 Months)
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Secondary outcome [1]
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Percentage of Participants With CR, PR, Stable Disease (SD), Progressive Disease (PD), or Not Evaluable (NE): Best Overall Intracranial Response (BOIR)
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Assessment method [1]
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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).
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Timepoint [1]
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Baseline to Earliest Objective Progression or Start of New Anticancer Therapy (Up to 36 Months)
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Secondary outcome [2]
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Duration of CR or PR: Duration of Intracranial Response (DOIR)
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Assessment method [2]
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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.
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Timepoint [2]
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Date of CR or PR to Date of Objective Disease Progression or Death from Any Cause (Up to 36 Months)
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Secondary outcome [3]
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Percentage of Participants With Best Overall Intracranial Response (BOIR) of CR, PR, or SD: Intracranial Disease Control Rate (IDCR)
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Assessment method [3]
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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.
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Timepoint [3]
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Baseline to Disease Progression or Start of New Anticancer Therapy (Up to 36 Months)
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Secondary outcome [4]
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Percentage of Participants With BOIR of CR, PR, or SD With Duration of SD for at Least 6 Months: Intracranial Clinical Benefit Rate (ICBR)
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Assessment method [4]
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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.
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Timepoint [4]
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Baseline to Disease Progression or Start of New Anticancer Therapy (Up to 36 Months)
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Secondary outcome [5]
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Overall Survival (OS)
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Assessment method [5]
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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.
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Timepoint [5]
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Baseline to the Date of Death from Any Cause (Up to 5 Years)
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Secondary outcome [6]
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Percentage of Participants With a Best Response of CR or PR: Extracranial Objective Response Rate (EORR)
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Assessment method [6]
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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.
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Timepoint [6]
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Baseline to Disease Progression (Up to 36 Months)
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Secondary outcome [7]
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Percentage of Participants With a Best Overall Response of CR, PR, or SD: Extracranial Disease Control Rate (EDCR)
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Assessment method [7]
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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.
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Timepoint [7]
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Baseline to Disease Progression or Start of New Anticancer Therapy (Up to 36 Months)
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Secondary outcome [8]
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Progression Free Survival (PFS) Bi-compartmental
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Assessment method [8]
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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.
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Timepoint [8]
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Baseline to Objective Disease Progression or Death from Any Cause (Up to 36 Months)
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Secondary outcome [9]
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Change From Baseline in Neurologic Symptoms on the MD Anderson Inventory-Brain Tumor (MDASI-BT) Subscale
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Assessment method [9]
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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.
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Timepoint [9]
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Baseline, Cycle 3 (Up to 63 Days)
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Secondary outcome [10]
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Pharmacokinetics (PK): Steady State Minimum Concentration (Cmin) of Abemaciclib and Its Metabolites LSN2839567 (M2), LSN3106726 (M20), and LSN3106729 (M18)
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Assessment method [10]
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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.
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Timepoint [10]
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Parts A, B, D, E, F, Cycle 3, Day 1: Predose; Part C, Cycle 4, Day 1: Predose
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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.
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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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.
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Non-randomised trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Open (masking not used)
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Who is / are masked / blinded?
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Intervention assignment
Single group
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Other design features
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Phase
Phase 2
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
20/04/2015
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
8/11/2019
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Sample size
Target
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Accrual to date
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Final
162
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Recruitment in Australia
Recruitment state(s)
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Recruitment hospital [1]
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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
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Recruitment hospital [2]
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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
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Recruitment hospital [3]
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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
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Recruitment hospital [4]
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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
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Recruitment postcode(s) [1]
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6009 - Nedlands
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Recruitment postcode(s) [2]
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2298 - Newcastle
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Recruitment postcode(s) [3]
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4215 - Southport
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Recruitment postcode(s) [4]
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4102 - Woolloongabba
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Recruitment outside Australia
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United States of America
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California
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United States of America
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Colorado
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United States of America
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District of Columbia
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Florida
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United States of America
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Hawaii
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United States of America
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Kentucky
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Massachusetts
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United States of America
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Michigan
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Missouri
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New York
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North Carolina
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Oregon
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Tennessee
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Texas
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Austria
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Wien
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Belgium
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Brussel
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Belgium
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Charleroi
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Belgium
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Leuven
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Belgium
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Liege
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Canada
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Ottawa
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France
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Lille Cedex
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France
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Lille
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France
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Lyon Cedex 08
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France
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Paris Cedex 05
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France
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Saint-Brieuc
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France
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Toulouse cedex 9
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Israel
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Jerusalem
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Israel
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Tel Hashomer
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Italy
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Cona
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Italy
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Genova
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Italy
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Padova
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Italy
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Roma
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Spain
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Barcelona
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Spain
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Madrid
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Spain
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Sevilla
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Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
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Name
Eli Lilly and Company
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Address
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Ethics approval
Ethics application status
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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.
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Trial website
https://clinicaltrials.gov/ct2/show/NCT02308020
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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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)
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Address
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Eli Lilly and Company
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Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT02308020
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