An Open Label, Single Arm, Phase 1b/2 Study With Pharmacokinetic Sampling to Evaluate LY2181308 in Patients With Advanced Hepatocellular Carcinoma
Phase 1/Phase 2
18 Years
N/A
18 Years
N/A
Not Enrolling
Both
Hepatocellular Carcinoma
Both
Hepatocellular Carcinoma
Trial Information
An Open Label, Single Arm, Phase 1b/2 Study With Pharmacokinetic Sampling to Evaluate LY2181308 in Patients With Advanced Hepatocellular Carcinoma
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
Type of Study:
Interventional
Study Design:
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
Phase 1: Determine recommended dose
Outcome Time Frame:
every cycle
Safety Issue:
Yes
Principal Investigator
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)
Investigator Role:
Study Director
Investigator Affiliation:
Eli Lilly and Company
Authority:
United States: Food and Drug Administration
Study ID:
10460
NCT ID:
NCT00415155
Start Date:
August 2008
Completion Date:
January 2011
Related Keywords:
- Hepatocellular Carcinoma
- Carcinoma
- Carcinoma, Hepatocellular
Name | Location |
|---|---|
| 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. | Manhassaet, New York |
| 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. | Greenbrae, California 94904 |
| 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. | Stamford, Connecticut 06902 |
| 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. | Albuquerque, New Mexico 87106 |
