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| Sponsored by: |
Genmab |
|---|---|
| Information provided by: | Genmab |
| ClinicalTrials.gov Identifier: | NCT00707655 |
Purpose
The purpose of this study is to investigate the safety of zalutumumab in combination with radiotherapy as the treatment of patients with head and neck cancer who are not eligible for platinum based chemotherapy.
| Condition | Intervention | Phase |
|---|---|---|
|
Head and Neck Cancer Squamous Cell Carcinoma |
Drug: zalutumumab |
Phase I Phase II |
| Study Type: | Interventional |
| Study Design: | Treatment, Non-Randomized, Open Label, Dose Comparison, Single Group Assignment, Safety Study |
| Official Title: | An Open-Label, International, Multi-Center, Phase I/II, Dose-Escalation Trial Investigating the Safety of Zalutumumab, a Human Monoclonal Epidermal Growth Factor Receptor Antibody in Combination With Radiotherapy, in Patients With Stage III, IVa or IVb Locally Advanced Squamous Cell Carcinoma of the Head and Neck Ineligible for Platinum Based Chemotherapy |
| Estimated Enrollment: | 24 |
| Study Start Date: | September 2008 |
| Estimated Study Completion Date: | November 2011 |
| Estimated Primary Completion Date: | November 2011 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
1
Dose finding
|
Drug: zalutumumab
Eight weekly infusions
|
|
2
Dose finding
|
Drug: zalutumumab
Eight weekly infusions
|
|
3
Dose finding
|
Drug: zalutumumab
Eight weekly infusions
|
|
4
Dose finding
|
Drug: zalutumumab
Eight weekly infusions
|
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| Contact: Karolina Jonsson, MSc Biochemistry | +45 7020 2728 | kjn@genmab.com |
| Belgium | |
| St-Luc University Hospital | Active, not recruiting |
| Brussels, Belgium | |
| Denmark, København K | |
| Genmab A/S | Not yet recruiting |
| Copenhagen, København K, Denmark, 1253 | |
| Contact: Karolina Jonsson, MSc +45 7020 2728 kjn@genmab.com | |
| France | |
| Centre Georges-Francois Leclerc Hospital | Recruiting |
| Dijon, France | |
| Institut Claudius Regaud Toulouse | Recruiting |
| Toulouse, France | |
| Medical Oncology, Outpatient Clinic | Active, not recruiting |
| Nantes, France | |
| United Kingdom | |
| The Royal Marsden NHS Foundation Trust | Not yet recruiting |
| London, United Kingdom | |
| Christie Hospital NHS Foundation Trust | Not yet recruiting |
| Manchester, United Kingdom | |
| Sheffield Teaching Hospitals NHS Foundation Trust | Not yet recruiting |
| Sheffield, United Kingdom | |
| Clinical Trials Unit, Northern Centre for Cancer Treatment | Not yet recruiting |
| Newcastle Upon Tyne, United Kingdom | |
More Information
| Responsible Party: | Genmab A/S ( Genmab A/S ) |
| Study ID Numbers: | GEN207 |
| Study First Received: | June 27, 2008 |
| Last Updated: | December 18, 2008 |
| ClinicalTrials.gov Identifier: | NCT00707655 |
| Health Authority: | France: Afssaps - French Health Products Safety Agency; Belgium: Directorate general for the protection of Public health: Medicines; United Kingdom: Medicines and Healthcare Products Regulatory Agency |
|
Epidermoid carcinoma Antibodies Squamous cell carcinoma Head and Neck Neoplasms Carcinoma, squamous cell Neoplasms, Squamous Cell |
Carcinoma, Squamous Cell Carcinoma, squamous cell of head and neck Immunoglobulins Neoplasms, Glandular and Epithelial Carcinoma |
|
Neoplasms Neoplasms by Site Neoplasms by Histologic Type |
