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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/NCT02735980
Registration number
NCT02735980
Ethics application status
Date submitted
31/03/2016
Date registered
13/04/2016
Date last updated
17/03/2020
Titles & IDs
Public title
A Study of Prexasertib (LY2606368) in Participants With Extensive Stage Disease Small Cell Lung Cancer
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Scientific title
A Phase 2 Study of LY2606368 in Patients With Extensive Stage Disease Small Cell Lung Cancer
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Secondary ID [1]
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I4D-MC-JTJH
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Secondary ID [2]
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16015
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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:
Small Cell Lung Cancer
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Condition category
Condition code
Cancer
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Lung - Mesothelioma
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Cancer
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Lung - Non small cell
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Cancer
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Lung - Small cell
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Drugs - Prexasertib
Experimental: Prexasertib (Platinum Sensitive Disease) - 105 mg/m^2 Intravenous (IV) prexasertib administered of every 14 days with extensive stage disease small cell lung cancer (ED-SCLC) who had platinum-sensitive disease (has prior platinum based therapy with subsequent progression greater or less than 90 days after last dose of platinum based therapy).
Experimental: Prexasertib (Platinum Resistant Disease) - 105 mg/m^2 IV prexasertib administered of every 14 days with extensive stage disease small cell lung cancer (ED-SCLC) who had resistant/refractory disease (did not have an objective response to platinum-based therapy or had progression greater than 90 days after the last dose of platinum).
Experimental: Prexasertib Exploratory Addendum (Platinum Sensitive Disease) - 40 mg/m^2 IV prexasertib Day 1, 2, and Day 3 of a 14 day cycle in participants with ED-SCLC platinum sensitive disease.
Treatment: Drugs: Prexasertib
Administered IV
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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 With Complete Response (CR) or Partial Response (PR) (Objective Response Rate [ORR])
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Assessment method [1]
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ORR was the percentage of participants achieving a best overall response (BOR) of complete response (CR) or partial response (PR) as per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1. CR defined as the disappearance of all target and non-target lesions and no appearance of new lesions. PR defined as at least a 30% decrease in the sum of the longest diameters (LD) of target lesions (taking as reference the baseline sum LD), no progression of non-target lesions, and no appearance of new lesions
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Timepoint [1]
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Baseline to 10 months
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Secondary outcome [1]
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Pharmacokinetics(PK): Maximum Concentration (Cmax) of Prexasertib Cohort 1 and Cohort 2
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Assessment method [1]
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Pharmacokinetics(PK): Maximum Concentration of Prexasertib. The same dose was administered to Cohort 1 and Cohort 2 and were combined for analysis.
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Timepoint [1]
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Cycle 1,3, 5, and 7: Day 1, Day 2 and Day 3- Prior to start of infusion, end of infusion plus 10 minutes, Day 8: anytime
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Secondary outcome [2]
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Pharmacokinetics(PK): Maximum Concentration of Prexasertib Cohort 3 (40 mg/m^2, Protocol Addenda)
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Assessment method [2]
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Pharmacokinetics(PK): Maximum Concentration of Prexasertib
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Timepoint [2]
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Cycle 1,3, 5, and 7: Day 1, Day 2 and Day 3- Prior to start of infusion, end of infusion plus 10 minutes, Day 8: anytime
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Secondary outcome [3]
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Pharmacokinetics: Area Under the Concentration Curve of Prexasertib
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Assessment method [3]
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Pharmacokinetics: Area Under the Concentration Curve of Prexasertib
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Timepoint [3]
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Cycle 1,3, 5, and 7: Day 1, Day 2 and Day 3- Prior to start of infusion, end of infusion plus 10 minutes, Day 8: anytime
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Secondary outcome [4]
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Disease Control Rate: Percentage of Participants With a Best Overall Response of CR, PR, or Stable Disease (SD)
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Assessment method [4]
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Disease control rate (DCR) is defined as the percentage of participants achieving a best overall response of CR, PR, or SD as determined by RECIST 1.1. CR is defined as a disappearance of all target lesions and any pathological lymph nodes must have reduction in short axis to <10 mm and normalization of tumor marker results; PR is defined as at least a 30% decrease in the sum of diameter of target lesions, taking as reference the baseline sum diameters; SD is defined as neither sufficient shrinking to qualify as PR nor sufficient increase to qualify for PD.
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Timepoint [4]
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Baseline through Disease Progression or Death from Any Cause to 28 months
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Secondary outcome [5]
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Progression-Free Survival (PFS)
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Assessment method [5]
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PFS defined as the from randomization date to the first evidence of disease progression as defined by RECIST v1.1 or death from any cause. Progressive Disease (PD) was at least a 20% increase in the sum of the diameters of target lesions, with reference being the smallest sum on study and an absolute increase of at least 5 mm, or unequivocal progression of non-target lesions, or 1 or more new lesions. If a participant does not have a complete baseline disease assessment, then the PFS time was censored at the date of first dose, regardless of whether or not objectively determined disease progression or death has been observed for the participant. If a participant was not known to have died or have objective progression as of the data inclusion cutoff date for the analysis, the PFS time was censored at the last adequate tumor assessment date.
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Timepoint [5]
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Baseline to Disease Progression or Death (up to 9 months)
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Secondary outcome [6]
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Duration of Response (DoR)
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Assessment method [6]
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DoR the time from the date of an objective response until Progressive Disease (PD): was at least a 20% increase in the sum of the diameters of target lesions, with reference being the smallest sum on study and an absolute increase of at least 5 mm, or unequivocal progression of non-target lesions, or 1 or more new lesions.
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Timepoint [6]
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Date of CR or PR to Date of Disease Progression or Death Due to Any Cause up to 9 months
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Secondary outcome [7]
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Overall Survival (OS)
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Assessment method [7]
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OS defined as from randomization date to the date of death due to any cause. For each participant who is not known to have died as of the data-inclusion cutoff date for overall survival analysis, OS time was censored on the last date the participant is known to be alive.
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Timepoint [7]
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Baseline up to 28 months
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Secondary outcome [8]
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Change From Baseline in Lung Cancer Symptom Scale Score (LCSS)
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Assessment method [8]
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LCSS is a 9-item questionnaire, six measuring major symptoms for lung malignancies (appetite, fatigue, cough, dyspnea, hemoptysis and pain), and 3 summation items related to total symptomatic distress, activity status and overall quality of life. Participant responses were measured using visual analogue scales (VAS) with 100-mm lines. The LCSS total score was defined as the mean of the 9 items of the scale, each scored between 0 (for best outcome) to 100 (for worst outcome).
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Timepoint [8]
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Baseline up to 9 months
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Secondary outcome [9]
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Change From Baseline on the Average Symptom Burden Index (ASBI)
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Assessment method [9]
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ABSI was the mean score for the six major lung cancer symptoms (appetite, fatigue, cough, dyspnea, hemoptysis and pain), each scored between 0 (for best outcome) to 100 (for worst outcome).
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Timepoint [9]
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Baseline up to 9 months
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Eligibility
Key inclusion criteria
- Have ED-SCLC and have received a prior platinum-based regimen
- Participants in Cohort 1 and in the addendum must have had an objective response to
prior platinum-based therapy with subsequent progression =90 days after the last dose
of platinum
- Participants in Cohort 2 must have either not had an objective response to prior
platinum based therapy or had progression <90 days after the last dose of platinum
- Have a performance status of 0 to 1 on the Eastern Cooperative Oncology Group scale
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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
- Have received more than 2 prior therapies for ED-SCLC (including immunotherapy,
targeted therapies, or chemotherapy)
- Have symptomatic central nervous system (CNS) malignancy or metastasis. Asymptomatic
participants with treated CNS metastases are eligible for this study if they are not
currently receiving corticosteroids to treat CNS metastases
- Have previously completed or withdrawn from this study or any other study
investigating prexasertib or a checkpoint kinase I (CHK1) inhibitor or have shown
hypersensitivity to any of the components of the prexasertib formulation
- Have a serious cardiac condition
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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
Parallel
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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
11/05/2016
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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
12/02/2019
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Sample size
Target
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Accrual to date
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Final
133
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Recruitment in Australia
Recruitment state(s)
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Recruitment outside Australia
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United States of America
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Arkansas
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Connecticut
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District of Columbia
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Florida
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Massachusetts
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Missouri
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Texas
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France
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Besancon Cedex
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France
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Lille
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France
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Montpellier
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France
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Vantoux
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Germany
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Halle
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Greece
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Athens
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Greece
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Heraklion
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Greece
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Patras
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Korea, Republic of
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Seoul
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Netherlands
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Amsterdam
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Netherlands
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Breda
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Zwolle
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Barcelona
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Spain
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Madrid
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Spain
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Zaragoza
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Turkey
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Antalya
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Edirne
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Istanbul
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Izmir
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Kayseri
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Ukraine
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Dnipropetrovsk
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Ukraine
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Kharkiv
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Ukraine
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Sumy
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United Kingdom
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Headington
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United Kingdom
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Leicester
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United Kingdom
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Sheffield
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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 purpose of this study is to evaluate the safety and efficacy of prexasertib when given to
participants with extensive stage disease small cell lung cancer (ED-SCLC). The study will
evaluate how the body processes the drug and how the drug affects the body. The study will
also evaluate the association between tumor response and the participant's perceived quality
of life.
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Trial website
https://clinicaltrials.gov/ct2/show/NCT02735980
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Trial related presentations / publications
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Public notes
This record is viewable in the ANZCTR as it had previously listed Australia and/or New Zealand as a recruitment site, however these sites have since been removed
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Contacts
Principal investigator
Name
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Call 1-877-CTLILLY (1-877-285-4559) 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 public queries
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Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT02735980
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