Study of Proxinium Plus Best Supportive Care Versus Best Supportive Care for Patients With Advanced Head and Neck Cancer

Study Overview
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Brief Summary
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The purpose of this study is to compare the safety and efficacy of Proxinium plus best supportive care with best supportive care only for patients with squamous cell head and neck cancer.

Detailed Description
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Head and neck cancer is a general description of a disease that includes several types of soft tissue carcinomas that develop in the head and neck regions. Proxinium is a recombinant fusion protein that binds to the epithelial cell adhesion molecule (Ep-CAM) that is highly expressed on squamous cell carcinomas of the head and neck (SCCHN). Proxinium is administered via intratumoural injection. 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 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

Official Title
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A Randomized, Multicentre Therapeutic Confirmatory Study to Evaluate the Efficacy and Safety of Proxinium Plus Best Supportive Care Versus Best Supportive Care Alone in Patients With Advanced SCCHN Who Have Received at Least One Anti-cancer Treatment Regimen for Advanced Disease

Conditions
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Carcinoma, Squamous Cell of Head and Neck, Carcinoma, Squamous Cell, Neoplasms, Squamous Cell, Head and Neck Neoplasms, Mouth Neoplasms, Head and Neck Cancer

Intervention / Treatment
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* Drug: Proxinium


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Disease Characteristics The patient must be 18 years of age or older. The patient must have squamous cell carcinoma of the head and neck. The squamous cell carcinoma must be Ep-CAM positive. ECOG performance status of 0, 1, 2 or 3. 12 week life expectancy Prior/Concurrent Therapy The patient must have received therapy for their primary disease (eg, surgery and/or radiotherapy, chemo-radiotherapy or chemotherapy). The patient must have been diagnosed with persistent or recurrent disease or a second primary tumour. The patient's disease must be refractory. There must be at least 2 weeks between the last dose of chemotherapy or radiotherapy and receiving study drug or 4 weeks between the last dose of an experimental drug and receiving study drug. Patient Characteristics The patient must have adequate hepatic function [alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤2.5 × upper limit of normal (ULN) and bilirubin level ≤1.5 × ULN]. The patient must have adequate renal function (serum creatinine < 1.5 × ULN). The patient must have the following hematological values: granulocytes ≥1500/μL, platelets ≥75 000/μL and hemoglobin >8 g/dL. The patient must have prothrombin time and partial thromboplastin time within normal limits. Other • Women of childbearing potential and male patients must agree to use a highly effective contraceptive method. Exclusion Criteria: The patient has clinically significant distant metastases. The patient is eligible to have surgical resection or radiotherapy, chemo-radiotherapy or chemotherapy. The patient has a nasopharyngeal tumour. The patient has AIDS, hepatitis C or hepatitis B. The patient has clinically significant renal or hepatic disease. Tumors are prone to bleeding. The patient is pregnant or lactating. The patient requires 'blood thinning' medications and can not safely discontinue the medication. The patient is currently enrolled in another clinical trial.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>Proxinium plus Best Supportive Care | Drug: Proxinium<br>* 700 µg Proxinium, once weekly until complete resolution of all target tumours or radiographic tumour progression<br>|
| No Intervention: 2<br>Best Supportive Care | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Survival |  | Death or 12 months from the date that the last patient required for efficacy analysis has been randomized | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Tumour response, safety and quality of life |  | Death or 12 months from the date that the last patient required for efficacy analysis has been randomized |