NCT01265576

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

A Randomized, Double Blind, Placebo Controlled, Multicenter Phase 2 Study of VT-122 in Combination With Sorafenib Compared to Sorafenib With Placebo in Patients With Hepatocellular Carcinoma and Systemic Inflammation at Risk for Cachexia

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 20 (actual)
• Sponsor: Vicus Therapeutics · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to determine if VT-122 provides a clinical benefit when added to Sorafenib in patients with advanced hepatocellular carcinoma (HCC).

Detailed description

The most common clinical course of the patient with cancer is local tumor progression leading to the development of metastases, systemic inflammation and the ensuing symptom cluster known as anorexia-cachexia syndrome. This syndrome includes cachexia (anorexia, weight loss and muscle wasting), fatigue, weakness, pain, dyspnea, nausea, malaise, depression and poor performance status. Patients suffering from this syndrome also have poor tolerance, adherence and response to anti-cancer therapy, resulting in disease progression and reduced life expectancy. In spite of the dire need, no proven options for treating inflammatory cancer cachexia are currently available. VT-122 is the co-administration of the cyclo-oxygenase 2 (COX-2) inhibitor, etodolac and the beta-adrenergic antagonist, propranolol. It is proposed that these drugs can attenuate systemic inflammation and ameliorate the symptoms of inflammatory cachexia in patients with advanced cancer. As a result, this treatment may improve tolerability and adherence to anti-cancer therapy, thereby yielding direct and indirect benefits in reducing disease progression and improving both the life expectancy and quality of life for patients with advanced cancer. The potentially synergistic activities of beta blockers and COX-2 inhibitors, their offsetting side effects and their known beneficial impact on co-morbidities associated with liver failure may make them well-suited for use with sorafenib, the standard of care for patients with advanced HCC. The purpose of this study is to assess whether use of VT-122 is safe and effective in cachectic patients with advanced HCC. In addition to assessing cachexia-related symptoms, the ability of the VT-122 regimen to improve tolerability to sorafenib and thereby to improve both survival and quality of life will also be assessed.

Conditions

• HCC

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2010-12-01
• Primary completion: 2014-02-01
• Completion: 2016-04-01
• First posted: 2010-12-23
• Last updated: 2015-12-09

Locations

10 sites across 1 country: United States