Digestive System Diseases

All Conditions

Neoplasms

Mouth and Tooth Diseases

Gastrointestinal Diseases

Head and Neck Neoplasms

Stomatitis

Mucositis

Stomatognathic Diseases

Mouth Diseases

Gastroenteritis

clinical trial material; (placebo or SCV 07) at doses of 0 (placebo), 0.1, 0.3, and 1.0 mg/kg will be administered sc

SCV-07

Placebo

Israel Rios, MD

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.

Study to Evaluate the Efficacy and Safety of Three Different Doses of SCV 07 in Attenuating Oral Mucositis in Subjects With Head and Neck Cancer

A Phase 2b, Multi-center, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of Three Different Doses of SCV 07 in Attenuating Oral Mucositis in Subjects With Head and Neck Cancer Receiving Concurrent Chemotherapy and Radiotherapy

The primary objective of the study is to evaluate the efficacy of SCV 07 in modifying the course of oral mucositis (OM) in subjects with head and neck cancer (HNC) receiving concurrent ChemoRT.

The secondary objective of the study is to evaluate the safety and tolerability of SCV 07.

SciClone Pharmaceuticals

Spots Global Cancer Trial Database for gastroenteritis