Status:
COMPLETED
A Study of Dovitinib Versus Sorafenib in Adult Patients With Hepatocellular Carcinoma (HCC) as a First Line Treatment
Lead Sponsor:
Novartis Pharmaceuticals
Conditions:
Hepatocellular Carcinoma
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
The purpose of this open-label, randomized, phase II study is to compare the safety and efficacy of dovitinib versus sorafenib as first-line treatment in adult patients with advanced Hepatocellular Ca...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
July 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2014
Estimated Enrollment :
162 Patients enrolled
Trial Details
Trial ID
NCT01232296
Start Date
July 1 2011
End Date
April 1 2014
Last Update
December 4 2015
Active Locations (24)
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1
Novartis Investigative Site
Nanjing, Jiangsu, China, 210002
2
Novartis Investigative Site
Xi’an, Shanxi, China, 710032
3
Novartis Investigative Site
Hangzhou, Zhejiang, China, 310016
4
Novartis Investigative Site
Beijing, China, 100039