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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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12 December 2020 |
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Main ID: |
NCT02735980 |
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Date of registration:
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31/03/2016 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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A Study of Prexasertib (LY2606368) in Participants With Extensive Stage Disease Small Cell Lung Cancer
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Scientific title:
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A Phase 2 Study of LY2606368 in Patients With Extensive Stage Disease Small Cell Lung Cancer |
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Date of first enrolment:
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May 11, 2016 |
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Target sample size:
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133 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT02735980 |
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Study type:
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Interventional |
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Study design:
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Allocation: Non-Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: None (Open Label).
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Phase:
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Phase 2
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Countries of recruitment
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Australia
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Belgium
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France
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Germany
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Greece
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Israel
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Italy
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Korea, Republic of
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Netherlands
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Spain
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Turkey
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Ukraine
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United Kingdom
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United States
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Contacts
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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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Telephone:
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Email:
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Affiliation:
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Eli Lilly and Company |
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Key inclusion & exclusion criteria
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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
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
Age minimum:
18 Years
Age maximum:
N/A
Gender:
All
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Health Condition(s) or Problem(s) studied
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Small Cell Lung Cancer
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Intervention(s)
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Drug: Prexasertib
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Primary Outcome(s)
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Percentage of Participants With Complete Response (CR) or Partial Response (PR) (Objective Response Rate [ORR])
[Time Frame: Baseline to 10 months]
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Secondary Outcome(s)
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Change From Baseline in Lung Cancer Symptom Scale Score (LCSS)
[Time Frame: Baseline up to 9 months]
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Change From Baseline on the Average Symptom Burden Index (ASBI)
[Time Frame: Baseline up to 9 months]
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Overall Survival (OS)
[Time Frame: Baseline up to 28 months]
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Pharmacokinetics(PK): Maximum Concentration (Cmax) of Prexasertib Cohort 1 and Cohort 2
[Time Frame: 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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Duration of Response (DoR)
[Time Frame: Date of CR or PR to Date of Disease Progression or Death Due to Any Cause up to 9 months]
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Disease Control Rate: Percentage of Participants With a Best Overall Response of CR, PR, or Stable Disease (SD)
[Time Frame: Baseline through Disease Progression or Death from Any Cause to 28 months]
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Pharmacokinetics(PK): Maximum Concentration of Prexasertib Cohort 3 (40 mg/m^2, Protocol Addenda)
[Time Frame: 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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Progression-Free Survival (PFS)
[Time Frame: Baseline to Disease Progression or Death (up to 9 months)]
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Pharmacokinetics: Area Under the Concentration Curve of Prexasertib
[Time Frame: 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 ID(s)
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16015
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2015-005069-21
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I4D-MC-JTJH
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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