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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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19 February 2015 |
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Main ID: |
NCT00415155 |
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Date of registration:
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20/12/2006 |
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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 LY2181308 in Patients With Advanced Hepatocellular Carcinoma
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Scientific title:
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An Open Label, Single Arm, Phase 1b/2 Study With Pharmacokinetic Sampling to Evaluate LY2181308 in Patients With Advanced Hepatocellular Carcinoma |
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Date of first enrolment:
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August 2008 |
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Target sample size:
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60 |
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Recruitment status: |
Withdrawn |
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URL:
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http://clinicaltrials.gov/show/NCT00415155 |
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Study type:
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Interventional |
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Study design:
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Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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Phase:
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Phase 1/Phase 2
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Countries of recruitment
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France
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Germany
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Spain
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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:
- Diagnosed with hepatocellular cancer
- Discontinued all previous therapies
- At least 18 years of age
Exclusion Criteria:
- Have other treatment options that are potentially curative or effective--such as
surgical resection, liver transplant or percutaneous ablation, and/or transcatheter
arterial embolization.
- Transplanted liver
- HIV positive
- More than 2 previous systemic chemotherapy treatments
Age minimum:
18 Years
Age maximum:
N/A
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Hepatocellular Carcinoma
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Intervention(s)
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Drug: LY2181308
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Primary Outcome(s)
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Phase 1: Determine recommended dose
[Time Frame: every cycle]
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Phase 2: Time to progression
[Time Frame: baseline to measured progressive disease]
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Secondary Outcome(s)
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Phase 2: Overall Survival
[Time Frame: Baseline to date of death from any cause]
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Phase 2: Safety
[Time Frame: every cycle]
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Phase 1: Safety
[Time Frame: every cycle]
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Phase 2: Pharmacokinetics
[Time Frame: Cycle 1 and Cycle 2]
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Phase 2: Response rate
[Time Frame: Baseline to measured PD]
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Secondary ID(s)
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H8Z-MC-JACS
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10460
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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