A Study of Dovitinib Versus Sorafenib in Adult Patients With Hepatocellular Carcinoma (HCC) as a First Line Treatment

Novartis

Status and phase: Completed; Phase 2

Conditions: Hepatocellular Carcinoma

Treatments: Drug: sorafenib; Drug: dovitinib

Study type: Interventional

Funder types: Industry

Identifiers

NCT01232296

CTKI258A2208

Details and patient eligibility

About

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 Carcinoma (HCC). This trial will be opened in countries of the Asia-Pacific region.

Enrollment: 162 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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162 participants in 2 patient groups

TKI258

Experimental group

Description:

capsule

Treatment:

Drug: dovitinib

Sorafenib

Experimental group

Description:

tablet

Treatment:

Drug: sorafenib