Trial Information
A Single Arm, Open Label Study of First Line Treatment With Tarceva Plus Avastin on Progression-free Survival in Patients With Advanced or Metastatic Liver Cancer
Inclusion Criteria:
- adult patients, >=18 years of age;
- advanced or metastatic liver cancer;
- >=1 measurable lesion, not previously treated with local therapy within 4 weeks of
enrollment.
Exclusion Criteria:
- prior or concomitant systemic anti-cancer treatment for advanced disease;
- patients at high risk of variceal bleeding;
- clinically significant cardiovascular disease;
- major surgery, open biopsy, or significant traumatic injury within 4 weeks of study
start.
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:
Progression-free survival
Outcome Time Frame:
Week 16
Safety Issue:
No
Principal Investigator
Clinical Trials
Investigator Role:
Study Director
Investigator Affiliation:
Hoffmann-La Roche
Authority:
Korea: Food and Drug Administration
Study ID:
ML21213
NCT ID:
NCT00605722
Start Date:
March 2008
Completion Date:
September 2010
Related Keywords:
- Liver Cancer
- Liver Neoplasms