A Randomized, Multicentre Therapeutic Confirmatory Study to Evaluate the Efficacy and Safety of ProxiniumTM Plus Best Supportive Care Versus Best Supportive Care Alone in Patients with Advanced Squamous Cell Carcinoma of the Head and Neck Who Have Received at Least One Anti-cancer Treatment Regimen for Advanced Disease - ND
- Conditions
- Advanced Squamous Cell Carcinoma of the Head and NeckMedDRA version: 9.1Level: HLTClassification code 10024530Term: Lip and oral cavity neoplasms malignant
- Registration Number
- EUCTR2005-005170-80-IT
- Lead Sponsor
- VIVENTIA BIOETICH INC
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 292
Inclusion Criteria
Patients must have advanced Ep-CAM positive SCCHN, have received at least 1 anti-cancer treatment regimen for their advanced disease and not be eligible for curative surgery or curative radiotherapy. Patients must have a life expectancy of at least 12 weeks, an ECOG performance status of 0, 1, 2 or 3 and have tumours that are suitable for intratumoural injection.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range
Exclusion Criteria
Patients will not be eligible for the study if they have clinically significant distant metastases or hepatic or renal disease.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: The primary objective of the Study is to compare the overall survival time for patients treated with intratumourally injected Proxinium plus BSC versus BSC alone.;Secondary Objective: Secondary objectives of the study include comparison of locoregional tumour control, local progression-free survival, symptomatic benefit and safety profile in patients who receive Proxinium plus BSC versus patients who receive BSC.;Primary end point(s): Overall survival time, measured as the time from randomozation to death from any cause
- Secondary Outcome Measures
Name Time Method