NCT01029418

AZD6244 and Sorafenib in Advanced Hepatocellular Carcinoma

A Phase 1/2 Study of AZD6244 in Combination With Sorafenib in Advanced Hepatocellular Carcinoma

• Status: Terminated
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 30 (actual)
• Sponsor: National Cancer Centre, Singapore · Academic / Other
• Sex: All
• Age: 21 Years
• Healthy volunteers: Not accepted

Summary

This will be a phase I/II clinical trial testing the combination of sorafenib and AZD6244 in advanced hepatocellular carcinoma with Childs A liver cirrhosis. The aim of the phase I portion is to determine appropriate dose of this drug combination. The phase 2 study will look at effectiveness and safety of this drug combination

Detailed description

Patients with unresectable BCLC Stage B/C hepatocellular carcinoma that is biopsy-proven ( histology or cytology from prior tumor biopsy specimen is acceptable Patients without prior systemic treatment ( chemotherapy or molecular targeted therapy) except prior adjuvant therapy, if given more than 6 months ago Child-Pugh class A only ECOG performance status 0 or 1

Conditions

• Hepatocellular Carcinoma

Interventions

Type	Name	Description
DRUG	AZD6244 and sorafenib	dose escalation of AZD6244; sorafenib 400mg bd

Timeline

• Start date: 2009-11-01
• Primary completion: 2014-02-01
• Completion: 2015-01-01
• First posted: 2009-12-10
• Last updated: 2015-04-16

Locations

2 sites across 1 country: Singapore