Zalutumumab in Patients With Non-curable Head and Neck Cancer - Full Text View

Purpose

The purpose of this study is to investigate if zalutumumab in combination with Best Supportive Care (BSC) is superior to BSC in non-curable patients with head and neck cancer

Condition	Intervention	Phase
Head and Neck Cancer Squamous Cell Cancer	Drug: Zalutumumab Other: Best Supportive Care	Phase 3

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment
Official Title:	An Open-Labeled Randomized Parallel Group Trial of Zalutumumab, a Human Monoclonal Anti-EGFr Antibody, in Combination With Best Supportive Care (BSC) vs BSC, in Pts With Non-Curable SCCHN Who Have Failed Standard Platinum-Based Chemotherapy

Resource links provided by NLM:

MedlinePlus related topics: Cancer Head and Neck Cancer

U.S. FDA Resources

Further study details as provided by Genmab:

Primary Outcome Measures:

Overall survival [ Time Frame: Until death ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Safety [ Time Frame: Until death ] [ Designated as safety issue: Yes ]
Time To Progression [ Time Frame: Until time to progression ] [ Designated as safety issue: No ]

Estimated Enrollment:	273
Study Start Date:	November 2006
Study Completion Date:	August 2011
Primary Completion Date:	December 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Active Comparator: 1 Zalutumumab in combination with Best Supportive Care	Drug: Zalutumumab Individual dose titration weekly i.v doses Other Name: Best Supportive Care
2 Best Supportive Care	Other: Best Supportive Care Best Supportive Care Other Name: Best Supportive Care

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Males and Females age ≥ 18 years
Confirmed diagnosis, initially or at relapse, of squamous cell carcinoma of the oral cavity, oropharynx, hypopharynx or larynx, considered incurable with standard therapy
Failure to at least one course of standard platinum-based chemotherapy

Exclusion Criteria:

Three or more chemotherapy regimens other than platinum-based chemotherapy
Prior treatment with EGFr antibodies and/or EGFr small molecule inhibitors
Past or current malignancy other than SCCHN, except for certain other cancer diseases

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00382031

Show 82 Study Locations

Sponsors and Collaborators

Genmab

Investigators

Study Chair:

.

Dept. of Medical Oncology, Cliniques Universitaires Saint-Luc Université Catholique de Louvain, Brussels, Belgium

More Information

No publications provided by Genmab

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Machiels JP, Subramanian S, Ruzsa A, Repassy G, Lifirenko I, Flygare A, Sørensen P, Nielsen T, Lisby S, Clement PM. Zalutumumab plus best supportive care versus best supportive care alone in patients with recurrent or metastatic squamous-cell carcinoma of the head and neck after failure of platinum-based chemotherapy: an open-label, randomised phase 3 trial. Lancet Oncol. 2011 Apr;12(4):333-43. Epub 2011 Mar 4.

Responsible Party:	Genmab
ClinicalTrials.gov Identifier:	NCT00382031 History of Changes
Other Study ID Numbers:	Hx-EGFr-202, Zalute
Study First Received:	September 27, 2006
Last Updated:	September 22, 2011
Health Authority:	Belgium: Directorate general for the protection of Public health: Medicines Sweden: Medical Products Agency Romania: National Medicines Agency United Kingdom: Medicines and Healthcare Products Regulatory Agency Lithuania: State Medicine Control Agency - Ministry of Health Serbia and Montenegro: Agency for Drugs and Medicinal Devices Russia: Pharmacological Committee, Ministry of Health Spain: Spanish Agency of Medicines Poland: Ministry of Health France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis) Hungary: National Institute of Pharmacy Estonia: The State Agency of Medicine Bulgaria: Ministry of Health Canada: Health Canada

Additional relevant MeSH terms:

Carcinoma, Squamous Cell
Neoplasms, Squamous Cell
Head and Neck Neoplasms
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type

Neoplasms
Neoplasms by Site
Antibodies, Monoclonal
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 19, 2013