Hepatocellular Carcinoma
A multicenter, global, randomized, double-blind study of axitinib plus best supportive care versus placebo plus best supportive care in patients with advanced hepatocellular carcinoma following failure of one prior antiangiogenic therapy
Enrollment Status: Closed for enrollment; patients continue to be followed.
Primary Objective
To compare the OS of patients with advanced HCC receiving axitinib + best supportive care (BSC) versus (vs) placebo + BSC following failure of one prior antiangiogenic therapy.
Study Design
- Patients will be randomized (2:1 ratio) to receive either axitinib + BSC (Arm A) or placebo + BSC (Arm B).
- Axitinib or placebo will be administered, twice daily (BID) on a continuous daily dosing schedule.
Main Inclusion Criteria
- Locally advanced or metastatic HCC
- Failure of one prior antiangiogenic therapy. Antiangiogenic agents include sorafenib, bevacizumab, and brivanib only.
- Child-Pugh Class A
- ECOG performance status 0 or 1
- Contact the study team for remaining details
Main Exclusion Criteria
- Contact study team for details.
Costs for the Patient
Most study-related testing costs covered by the sponsor; study medication provided free of charge.
Contact persons
Sherry Fu – (734) 647-3635 or sherryfu@med.umich.edu
Micael Volk, MD – mvolk@med.umich.edu
A multicenter, randomized, double-blind, phase 3 study of ramucirumab (IMC-1121B) drug product and best supportive care (BSC) versus placebo and BSC as second-line treatment in patients with hepatocellular carcinoma following first-line therapy with sorafenib
Enrollment Status: Closed for enrollment; patients continue to be followed.
Primary Objective
The primary objective is to compare the overall survival (OS; time from randomization to death) in patients with hepatocellular carcinoma (HCC) who had disease progression during or following sorafenib therapy, or were intolerant to this agent. Patients will receive either ramucirumab (IMC-1121B) drug product (hereafter referred to as ramucirumab DP) plus best supportive care (BSC) or placebo plus BSC.
Study Design
1:1 randomization of IV ramucirumab/placebo infusion every 2 weeks. A treatment cycle will be defined as 2 weeks, with radiologic evaluation every 6 weeks (± 3 days) after first dose of study therapy for the first 6 months, and every 9 weeks (± 3 days) thereafter.
Main Inclusion Criteria
- Locally advanced or metastatic HCC
- Must have failed sorafenib. Sorafenib must have been the most recent treatment.
- Child-Pugh score of < 9
- ECOG performance status 0 or 1.
- Contact the study team for remaining details
Main Exclusion Criteria
-
Contact study team for details.
Costs for the Patient
Most study-related testing costs covered by the sponsor; study medication provided free of charge.
Contact persons
Sherry Fu – (734) 647-3635 or sherryfu@umich.edu
Micael Volk, MD – mvolk@med.umich.edu
