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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: |
NCT02117648 |
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Date of registration:
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16/04/2014 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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A Study of LY2835219 in Participants With Cancer
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Scientific title:
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Effects of CYP3A Inhibition by Clarithromycin on the Pharmacokinetics of LY2835219 and Its Metabolites in Cancer Patients |
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Date of first enrolment:
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April 2014 |
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Target sample size:
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26 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT02117648 |
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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: Single Group Assignment. Primary purpose: Basic Science. Masking: None (Open Label).
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Phase:
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Phase 1
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Countries of recruitment
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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 histological or cytological evidence of cancer (solid tumors) that is advanced
and/or metastatic
- Have a performance status of 0 to 2 on the Eastern Cooperative Oncology Group (ECOG)
scale
Exclusion Criteria:
- No symptomatic central nervous system (CNS) malignancy or metastasis
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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Neoplasm
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Neoplasm Metastasis
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Intervention(s)
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Drug: Abemaciclib
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Drug: Clarithromycin
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Primary Outcome(s)
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PK: Maximum Concentration (Cmax) of Abemaciclib
[Time Frame: Period 1: Predose; 1, 2, 4, 6, 8, 10, 24, 48, 72, 96,120,144,168hr, Period 2: 1, 2, 4, 6, 8, 10, 24, 48, 72, 96, 120, 144, 168, 192, 216, 240hr Post dose]
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Pharmacokinetics (PK): Area Under the Concentration Time Curve From Zero to Infinity (AUC[0-8]) of Abemaciclib
[Time Frame: Period 1: Predose; 1, 2, 4, 6, 8, 10, 24, 48, 72, 96, 120, 144, 168hr, Period 2: 1, 2, 4, 6, 8, 10, 24, 48, 72, 96, 120, 144, 168, 192, 216, 240hr Post dose]
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Secondary ID(s)
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15173
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I3Y-MC-JPBE
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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