Study of Sorafenib With or Without VT-122 in Patients With Hepatocellular Carcinoma (HCC)

PHASE2UnknownINTERVENTIONAL
Enrollment

20

Participants

Timeline

Start Date

December 31, 2010

Primary Completion Date

February 28, 2014

Study Completion Date

April 30, 2016

Conditions
HCC
Interventions
DRUG

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.

DRUG

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.

DRUG

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.

Trial Locations (10)

10016

Vicus Clinical Site, New York

14263

Vicus Clinical Site, Buffalo

30318

Vicus Clinical Site, Atlanta

77024

Vicus Clinical Site, Houston

77030

Vicus Clinical Site, Houston

94704

Vicus Clinical Site, Berkeley

Unknown

Vicus Clinical Site, New Brunswick

Vicus Clinical Site, Philadelphia

07103

Vicus Clinical Site, Newark

07503

Vicus Clinical Site, Paterson

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Vicus Therapeutics

INDUSTRY

NCT01265576 - Study of Sorafenib With or Without VT-122 in Patients With Hepatocellular Carcinoma (HCC) | Biotech Hunter | Biotech Hunter