An Open-label, Randomized, Multi-center, Phase II Study to Compare the Safety and Efficacy of TKI258 Versus Sorafenib as First-line Treatment in Adult Patients With Advanced Hepatocellular Carcinoma
Phase 2
18 Years
N/A
18 Years
N/A
Open (Enrolling)
Both
Hepatocellular Carcinoma
Both
Hepatocellular Carcinoma
Trial Information
An Open-label, Randomized, Multi-center, Phase II Study to Compare the Safety and Efficacy of TKI258 Versus Sorafenib as First-line Treatment in Adult Patients With Advanced Hepatocellular Carcinoma
Inclusion Criteria:
Diagnosis of advanced Hepatocellular Carcinoma (HCC) according to the AASLD Guidelines
- Advance HCC Stage B and C according to BCLC staging classification
- Child Pugh A
- At least one measurable lesion as assessed by CT or MRI
- ECOG PS of 0 or 1
- Adequate bone marrow, liver, and renal function
Exclusion Criteria:
- Prior systemic therapy for HCC
- Brain metastases
- Active bleeding (including variceal bleeding as the result of esophageal varices)
Patients who have received a liver transplant or are awaiting an immediate transplant
Other protocol-defined inclusion/exclusion criteria may apply
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
Overall Survival - Overall survival
Outcome Time Frame:
Every 6 weeks after disease progression
Safety Issue:
Yes
Principal Investigator
Novartis Pharmaceuticals
Investigator Role:
Study Director
Investigator Affiliation:
Novartis Pharmaceuticals
Authority:
United States: Food and Drug Administration
Study ID:
CTKI258A2208
NCT ID:
NCT01232296
Start Date:
July 2011
Completion Date:
July 2013
Related Keywords:
- Hepatocellular Carcinoma
- Hepatocellular Carcinoma
- HCC
- Liver cancer
- Child Pugh A
- HCC Stage C
- Carcinoma
- Carcinoma, Hepatocellular
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