Hepatocellular Carcinoma
Conditions
Brief summary
The primary objective of this study is to estimate the time to progressive disease for patients with advanced hepatocellular cancer who receive LY2181308.
Interventions
DRUGLY2181308
Phase 1: 250mg, IV, loading dose days 1-3 cycle 1 then weekly for six 28 day cycle. (dose escalation) Phase 2: phase 1 recommended dose, maximum 750mg dose, IV, loading dose days 1-3 cycle 1 then weekly for six 28 day cycle.
Sponsors
Eli Lilly and Company
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Phase 1: Determine recommended dose | every cycle |
| Phase 2: Time to progression | baseline to measured progressive disease |
Secondary
| Measure | Time frame |
|---|---|
| Phase 2: Response rate | Baseline to measured PD |
| Phase 1: Safety | every cycle |
| Phase 2: Safety | every cycle |
| Phase 2: Pharmacokinetics | Cycle 1 and Cycle 2 |
| Phase 2: Overall Survival | Baseline to date of death from any cause |
Countries
France, Germany, Spain, United States
Outcome results
None listed