NCT00971126

Study of Sorafenib With Combination of Thalidomide in Hepatocellular Carcinoma (HCC)

A Phase I/II Study of Sorafenib With Combination of Thalidomide in Advanced or Metastatic Hepatocellular Carcinoma

• Status: Terminated
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 3 (actual)
• Sponsor: National Health Research Institutes, Taiwan · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this phase I study is to determine the maximal tolerable dose (MTD) of thalidomide (THADO®) in combination with fixed dose of sorafenib (NEXAVAR®) for the treatment of advanced or metastatic HCC. The Phase II purpose of this study is to determine the disease control rate (complete response + partial response + stable disease) for at least 4 months of sorafenib (NEXAVAR®) plus phase I determined MTD of thalidomide (THADO®) in patients with advanced or metastatic HCC.

Detailed description

This is a non-randomized, open-labeled, single-arm, multi-center, phase I /II clinical study. The Phase I purpose of this study is to determine the maximal tolerable dose (MTD) of thalidomide (THADO®) in combination with fixed dose of sorafenib (NEXAVAR®) for the treatment of advanced or metastatic HCC, and the dose-limiting toxicity (DLT) profiles and other toxicity profiles in patients receiving fixed dose of sorafenib (NEXAVAR®) plus escalating dose of thalidomide (THADO). The Phase II primary objective of this study is to determine the disease control rate (complete response + partial response + stable disease) for at least 4 months of sorafenib (NEXAVAR®) plus phase I determined MTD of thalidomide (THADO®) in patients with advanced or metastatic HCC. The Phase II secondary objective of this study is to determine the objective tumor response rate, the time to tumor progression, the progression-free survival, the overall survival, and the safety and adverse event profiles, the changes of circulating biomarkers relating to angiogenesis and their correlation with disease control rate. The sample size are required up to 24 patients for the phase I study and 53 patients for the phase II study. Sorafenib (NEXAVAR®): supplied to Good Manufacturing Practice standards by Bayer Health Care, Taiwan as a film-coated tablet, each of which contains sorafenib tosylate (274mg) equivalent to 200 mg of sorafenib. Thalidomide (THADO®): supplied to Good Manufacturing Practice standards by TTY Biopharm Co., Ltd. as a white-yellow capsule, each of which contains 50 mg of thalidomide.

Conditions

• Hepatocellular Carcinoma

Interventions

Type	Name	Description
DRUG	sorafenib (Nexavar®), thalidomide (Thado®)	Phase I Fixed dose of Sorafenib 800mg/day (400mg, p.o., bid); and Escalation dose of Thalidomide at dose Level I: 50 mg/day (50mg, p.o., qd); Level II: 100 mg/day (50mg, p.o., bid); Level III: 150 mg/day (100mg/50mg, p.o., bid); Level IV: 200 mg/day (100mg, p.o., bid). Phase II Fixed dose of Sorafenib 800mg/day (400mg, p.o., bid); and MTD of Thalidomide at phase I study.

Timeline

• Start date: 2009-07-01
• Primary completion: 2010-01-01
• Completion: 2010-03-01
• First posted: 2009-09-03
• Last updated: 2016-05-04

Locations

1 site across 1 country: Taiwan