20
Participants
Start Date
December 31, 2010
Primary Completion Date
February 28, 2014
Study Completion Date
April 30, 2016
Sorafenib
Participants will be on sorafenib at least 30 days before randomization into either the Treatment or Control Arms. Sorafenib will be administered according to the package insert unless contraindicated based on physician expertise.
VT-122 (propranolol plus etodolac)
Participants randomized to the VT-122 regimen (sorafenib plus VT-122) will receive oral doses of propranolol and etodolac, which will be titrated over a period of 3 weeks until the participant reaches a maximum tolerated dose (MTD)\[no higher than 60 mg propranolol, twice daily (BID)/300 mg etodolac, BID\]. Once the individual MTD has been reached, participants will enter a Maintenance Treatment period, and will receive the VT-122 regimen (propranolol and etodolac, co administered orally) on a continuous BID dosing schedule for a maximum of twelve 4-week cycles.
Placebo
Participants randomized to the Control Arm (sorafenib with placebo) will receive placebo for the same periods as participants randomized to the Treatment Arm. Participants in the Control Arm will undergo the same visits and mock dose escalation.
Vicus Clinical Site, New York
Vicus Clinical Site, Buffalo
Vicus Clinical Site, Atlanta
Vicus Clinical Site, Houston
Vicus Clinical Site, Houston
Vicus Clinical Site, Berkeley
Vicus Clinical Site, New Brunswick
Vicus Clinical Site, Philadelphia
Vicus Clinical Site, Newark
Vicus Clinical Site, Paterson
Lead Sponsor
Vicus Therapeutics
INDUSTRY