Zalutumumab in Non-Curable Patients With SCCHN - Full Text View

Sponsored by:	Genmab
Information provided by:	Genmab
ClinicalTrials.gov Identifier:	NCT00542308

Purpose

Treatment, In combination with BSC, Open-label, Single arm, Efficacy Study.

Condition	Intervention	Phase
Head and Neck Cancer Squamous Cell Cancer	Drug: Zalutumumab	Phase II

MedlinePlus related topics: Cancer Head and Neck Cancer

Drug Information available for: Immunoglobulins Globulin, Immune Zalutumumab

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Non-Randomized, Open Label, Single Group Assignment, Efficacy Study
Official Title:	An Open Label Single Arm Trial Investigating Zalutumumab, a Human Monoclonal Anti-EGF Receptor Antibody, in Combination With Best Supportive Care, in Patients With Non-Curable Squamous Cell Carcinoma of the Head and Neck Who Have Failed Standard Platinum-Based Chemotherapy.

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:	100
Study Start Date:	January 2008
Estimated Study Completion Date:	October 2009
Estimated Primary Completion Date:	October 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1 Single-arm	Drug: Zalutumumab Individual dose titration weekly i.v. doses

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 prior chemotherapy regimens
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: NCT00542308

Contacts

Contact: Liz Svensson, Ph.D.	+45 7020 2728	liz@genmab.com
Contact: Tahira Carbone	+1 609 524 0835	t.carbone@genmab.com

Locations

United States, Alabama
University of Alabama at Birmingham	Recruiting
Birmingham, Alabama, United States, 35294-0012
United States, California
UCSD Moores Cancer Center	Withdrawn
La Jolla, California, United States, 92093
Loma Linda University Cancer Institute	Recruiting
Loma Linda, California, United States, 92354
United States, Florida
Moffitt Cancer Center	Recruiting
Tampa, Florida, United States, 33612
Gainsville Hematology Oncology Associates	Recruiting
Gainsville, Florida, United States, 32605
United States, Idaho
Mountain States Tumor Institute	Recruiting
Boise, Idaho, United States, 83712
United States, Illinois
University Of Chicago Medical Center	Recruiting
Chicago, Illinois, United States, 60637
Joliet Oncology-Hematology Associates, Ltd	Withdrawn
Joliet, Illinois, United States, 60435
Warren Billhartz Cancer Center	Recruiting
Maryville, Illinois, United States, 62062
Rush University Medical Center	Recruiting
Chicago, Illinois, United States, 60612
St. John's Hospital	Recruiting
Springfield, Illinois, United States, 62769
United States, Indiana
Ft. Wayne Medical Oncology/Hematology, Inc	Recruiting
Ft. Wayne, Indiana, United States, 46815
United States, Michigan
Henry Ford Health Systems	Recruiting
Detroit, Michigan, United States, 48202
United States, New York
New York Oncology, Hematology	Withdrawn
Albany, New York, United States, 12208
New York Oncology	Recruiting
Albany, New York, United States, 12206
United States, Oregon
Oregon Health and Science University	Recruiting
Portland, Oregon, United States, 97239
United States, Texas
Baylor University Medical Center	Recruiting
Dallas, Texas, United States, 75246
Tyler Cancer Center	Withdrawn
Tyler, Texas, United States, 75702
Czech Republic
Fakultní nemocnice Olomouc	Recruiting
Olomouc, Czech Republic, 775 20
Italy
Istituto Nazionale Tumori	Recruiting
Milan, Italy, 20133
Slovakia
Avimed s.r.o.	Recruiting
Rimavská Sobota, Slovakia, 979 01

Sponsors and Collaborators

Genmab

Investigators

Study Director:

Lars Damstrup, MD, PhD

Genmab A/S, Toldbodgade 59B, DK-1253 Copenhagen K, Denmark

More Information

Responsible Party:	Genmab A/S ( Genmab A/S )
Study ID Numbers:	GEN205
Study First Received:	October 10, 2007
Last Updated:	December 18, 2008
ClinicalTrials.gov Identifier:	NCT00542308
Health Authority:	United States: Food and Drug Administration

Study placed in the following topic categories:

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

Additional relevant MeSH terms:

Neoplasms
Neoplasms by Site
Neoplasms by Histologic Type

ClinicalTrials.gov processed this record on January 15, 2009