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Cancer Vaccine
SCV-07 0.3mg/kg for Mouth sores
Phase 2
Waitlist Available
Research Sponsored by SciClone Pharmaceuticals
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up june 2012
Summary
This is a phase 2b, double-blind, placebo-controlled, 4-arm, adaptive-design trial, initially stratified by cisplatin regimen, and then randomized 1:1:1:1. The study will be conducted in subjects receiving ChemoRT for the treatment of squamous cell carcinomas (SCCs) of the oral cavity, oropharynx, hypopharynx, or larynx. The study includes a treatment period of approximately 7 weeks, depending on the subject's prescribed radiation plan, and Week 1 and Week 4 post RT follow-up visits. It also includes a longer follow-up period of approximately 12 months to determine if there is an effect of SCV 07 on the tumor response to ChemoRT.
Eligible Conditions
- Mouth sores
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ june 2012
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~june 2012
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Efficacy
Secondary study objectives
Safety
Trial Design
4Treatment groups
Active Control
Placebo Group
Group I: SCV-07 0.3mg/kgActive Control1 Intervention
Group II: SCV-07 0.1mg/kgActive Control1 Intervention
Group III: SCV-07 1.0mg/kgActive Control1 Intervention
Group IV: PlaceboPlacebo Group1 Intervention
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Who is running the clinical trial?
SciClone PharmaceuticalsLead Sponsor
20 Previous Clinical Trials
4,812 Total Patients Enrolled
Israel Rios, MDStudy DirectorSciClone Pharmaceuticals
1 Previous Clinical Trials
59 Total Patients Enrolled
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