Trial document
This study has been imported from ClinicalTrials.gov without additional data checks.
DRKS00003754
Trial Description
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.
Trial Acronym
[---]*
URL of the Trial
[---]*
Brief Summary in Lay Language
Treatment, In combination with BSC, Open-label, Single arm, Efficacy Study.
Brief Summary in Scientific Language
[---]*
Organizational Data
- DRKS00003754
- 2012/06/20
- 2007/10/10
- no
- [---]*
- [---]*
Secondary IDs
- NCT00542308 (ClinicalTrials.gov)
- GEN205 (Genmab)
Health Condition or Problem studied
- Head and Neck Cancer
- Squamous Cell Cancer
Interventions/Observational Groups
- Drug: Zalutumumab
Characteristics
- Interventional
- [---]*
- Single arm study
- Open (masking not used)
- [---]*
- Uncontrolled/Single arm
- [---]*
- Single (group)
- II
- [---]*
Primary Outcome
- Overall survival; time frame: Until death
Secondary Outcome
- Safety; time frame: Until death
- Time to progression; time frame: Until time to progression
Countries of Recruitment
- United States
- Austria
- Chile
- Colombia
- Czech Republic
- Germany
- Israel
- Italy
- Peru
- Portugal
- Slovakia
Locations of Recruitment
Recruitment
- [---]*
- 2008/01/31
- 90
- Multicenter trial
- International
Inclusion Criteria
- Both, male and female
- 18 Years
- no maximum age
Additional Inclusion Criteria
1. Males and females age ≥ 18 years
2. Confirmed diagnosis, initially or at relapse, of squamous cell carcinoma of the oral
cavity, oropharynx, hypopharynx or larynx, considered incurable with standard therapy
3. Failure to at least one course of standard platinum-based chemotherapy
Exclusion Criteria
1. Three or more prior chemotherapy regimens
2. Prior treatment with EGFr antibodies and/or EGFr small molecule inhibitors
3. Past or current malignancy other than SCCHN, except for certain other cancer diseases
Addresses
-
start of 1:1-Block address primary-sponsor
- Genmab
end of 1:1-Block address primary-sponsorstart of 1:1-Block address contact primary-sponsor- [---]*
- [---]*
- [---]*
- [---]*
end of 1:1-Block address contact primary-sponsor -
start of 1:1-Block address scientific-contact
- Genmab A/S, Bredgade 34, DK-1260 Copenhagen K, Denmark
- Steen Lisby, MD
end of 1:1-Block address scientific-contactstart of 1:1-Block address contact scientific-contact- [---]*
- [---]*
- [---]*
- [---]*
end of 1:1-Block address contact scientific-contact -
start of 1:1-Block address public-contact
- Genmab A/S, Bredgade 34, DK-1260 Copenhagen K, Denmark
- Steen Lisby, MD
end of 1:1-Block address public-contactstart of 1:1-Block address contact public-contact- [---]*
- [---]*
- [---]*
- [---]*
end of 1:1-Block address contact public-contact
Sources of Monetary or Material Support
-
start of 1:1-Block address materialSupport
- [---]*
end of 1:1-Block address materialSupportstart of 1:1-Block address contact materialSupport- [---]*
- [---]*
- [---]*
- [---]*
end of 1:1-Block address contact materialSupport
Status
- Recruiting complete, follow-up complete
- 2011/08/01
Trial Publications, Results and other Documents
- [---]*
- 10
- 2013/10/30