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Zalutumumab With or Without Irinotecan Chemotherapy in Cetuximab-Refractory Colorectal Cancer (GEN206)

This study has been terminated.
(Due to changes in portfolio review)
Sponsor:
Information provided by (Responsible Party):
Genmab
ClinicalTrials.gov Identifier:
NCT00677924
First received: May 13, 2008
Last updated: November 21, 2011
Last verified: November 2011

May 13, 2008
November 21, 2011
April 2008
April 2009   (final data collection date for primary outcome measure)
Adverse Events [ Time Frame: Overall Study ] [ Designated as safety issue: Yes ]
Number of patients experiencing an adverse event
Adverse Events and objective response rate [ Time Frame: Until disease progression ] [ Designated as safety issue: Yes ]
Complete list of historical versions of study NCT00677924 on ClinicalTrials.gov Archive Site
Best Overall Response [ Time Frame: Overall Study ] [ Designated as safety issue: No ]
Best overall response according to RECIST criteria J Natl Cancer Inst 2000;92:205-16
Duration of overall response and progression free survival [ Time Frame: Until time to response or progression ] [ Designated as safety issue: Yes ]
Not Provided
Not Provided
 
Zalutumumab With or Without Irinotecan Chemotherapy in Cetuximab-Refractory Colorectal Cancer
A Dose-Escalation, Randomized Phase I/II Trial of Zalutumumab - a Human Monoclonal Anti-EGF Receptor Antibody - With or Without Irinotecan Chemotherapy in Cetuximab Refractory Colorectal Cancer Patients Who Have Failed Standard Chemotherapy and Progressed During or Within 3 Months of Stopping Cetuximab-Based Therapy

The purpose of this trial is to determine the safety and efficacy of Zalutumumab alone or in combination with Irinotecan for the treatment of patients with Colorectal Cancer

Not Provided
Interventional
Phase 1
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Colorectal Cancer
Drug: Zalutumumab
Solution for infusion
Other Name: HuMax-EGFr
  • Experimental: Zalutumumab 8 mg/kg
    Zalutumumab in combination with Irinotecan
    Intervention: Drug: Zalutumumab
  • Experimental: Zalutumumab 16 mg/kg
    Zalutumumab in combination with Irinotecan
    Intervention: Drug: Zalutumumab
Mano M, Hendlisz A, Machiels JP, Ehrnrooth E, Aladdin H, Van Laethem JL. Phase I trial of zalutumumab and irinotecan in metastatic colorectal cancer patients who have failed irinotecan and cetuximab based therapy. J Clin Oncol 27 2009 (suppl;abstr e15028)

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
9
April 2009
April 2009   (final data collection date for primary outcome measure)

Inclusion Criteria:

  1. Males and Females age ≥ 18 years
  2. Confirmed diagnosis of CRC
  3. Documented disease progression
  4. Failure and/or intolerance to standard chemotherapy

Exclusion Criteria:

  1. Prior treatment with anti-EGFR antibodies other than cetuximab
  2. Expected survival < 3 months
  3. Clinical significant cardiac disease and/or uncontrolled medical conditions
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Belgium
 
NCT00677924
GEN206
Yes
Genmab
Genmab
Not Provided
Study Director: Hassan Aladdin, ICTM Genmab
Genmab
November 2011

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