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Trial record 1 of 1 for:    An Open label single arm trial investigating zalutumumab, a Human Monoclonal Anti-EGF receptor Antibody, in combination
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Zalutumumab in Non-curable Patients With SCCHN

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00542308
Recruitment Status : Completed
First Posted : October 11, 2007
Results First Posted : August 27, 2014
Last Update Posted : August 27, 2014
Sponsor:
Information provided by (Responsible Party):
Genmab

Tracking Information
First Submitted Date  ICMJE October 10, 2007
First Posted Date  ICMJE October 11, 2007
Results First Submitted Date  ICMJE August 12, 2014
Results First Posted Date  ICMJE August 27, 2014
Last Update Posted Date August 27, 2014
Study Start Date  ICMJE January 2008
Actual Primary Completion Date August 2011   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 12, 2014)
Overall Survival [ Time Frame: From randomization until death, assessed up to 21 months ]
Overall survival was defined as time from start of treatment until date of death of any cause.
Original Primary Outcome Measures  ICMJE
 (submitted: October 10, 2007)
Overall Survival
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: August 12, 2014)
Tumour Response [ Time Frame: During treatment and two weeks after end of treatment, assessed up to 21 months. ]
Tumour response according to Response Evaluation Criteria in Solid Tumours (RECIST v 1.0)J Natl Cancer Inst 2000;92:205-16 assessed by CT/MRI. Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the longest diameter of target lesions; Overall Response (OR), CR+PR
Original Secondary Outcome Measures  ICMJE
 (submitted: October 10, 2007)
Efficacy, safety
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Zalutumumab in Non-curable Patients With SCCHN
Official Title  ICMJE 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.
Brief Summary Treatment, In combination with BSC, Open-label, Single arm, Efficacy Study.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Condition  ICMJE
  • Head and Neck Cancer
  • Squamous Cell Cancer
Intervention  ICMJE Drug: Zalutumumab
Individual dose titration weekly i.v. doses
Study Arms  ICMJE Experimental: Zalutumumab 4-16 mg/kg
Zalutumumab iv infusion once weekly. The dose was titrated until grade 2 rash occurred.
Intervention: Drug: Zalutumumab
Publications * Saloura V, Cohen EE, Licitra L, Billan S, Dinis J, Lisby S, Gauler TC. An open-label single-arm, phase II trial of zalutumumab, a human monoclonal anti-EGFR antibody, in patients with platinum-refractory squamous cell carcinoma of the head and neck. Cancer Chemother Pharmacol. 2014 Jun;73(6):1227-39. doi: 10.1007/s00280-014-2459-z. Epub 2014 Apr 9.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: January 2, 2012)
90
Original Estimated Enrollment  ICMJE
 (submitted: October 10, 2007)
100
Actual Study Completion Date  ICMJE August 2011
Actual Primary Completion Date August 2011   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Austria,   Chile,   Colombia,   Czech Republic,   Germany,   Israel,   Italy,   Peru,   Portugal,   Slovakia,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00542308
Other Study ID Numbers  ICMJE GEN205
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Genmab
Study Sponsor  ICMJE Genmab
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Steen Lisby, MD Genmab A/S, Bredgade 34, DK-1260 Copenhagen K, Denmark
PRS Account Genmab
Verification Date January 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP