NCT00756951

Dose Ranging Study to Assess the Safety and Efficacy of SCV-07 for the Delay to Onset of Severe Oral Mucositis in Patients Receiving Chemoradiation Therapy for Head and Neck Cancer

A Phase 2, Multi-center, Randomized, Double-blind, Placebo-controlled, Dose Ranging Study to Assess the Safety and Efficacy of SC-07 for the Delay to Onset of Severe Oral Mucositis in Subjects Receiving Chemoradiation Therapy for the Treatment of Cancers of the Head and Neck.

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 59 (planned)
• Sponsor: SciClone Pharmaceuticals · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Oral Mucositis (OM) is a painful and debilitating side effect of many of the drug or radiation regiments used to treat cancer. This study examines the investigational drug SCV-07 and it's possible application in treating Oral Mucositis. Studies have shown that SCV-07 can possibly increase a broad immune system response, thus lowering the painful side effects experienced when treated for head and neck cancer. The purpose of this study is to assess the safety and tolerability of SCV-07 and it's ability to delay the onset of Oral Mucositis for patients receiving chemoradiation for head and neck cancer.

Conditions

• Oral Mucositis
• Head and Neck Cancer

Interventions

Type	Name	Description
DRUG	Placebo	Placebo
DRUG	SCV-07	0.02 mg/kg
DRUG	SCV-07	0.10 mg/kg

Timeline

• Start date: 2008-09-01
• First posted: 2008-09-22
• Last updated: 2009-11-23

Locations

19 sites across 1 country: United States