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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:
ClinicalTrials.gov Identifier:
NCT00677924
First Posted: May 15, 2008
Last Update Posted: December 23, 2011
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.
Information provided by (Responsible Party):
Genmab
  Purpose
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

Condition Intervention Phase
Colorectal Cancer Drug: Zalutumumab Phase 1 Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:


Further study details as provided by Genmab:

Primary Outcome Measures:
  • Adverse Events [ Time Frame: Overall Study ]
    Number of patients experiencing an adverse event


Secondary Outcome Measures:
  • Best Overall Response [ Time Frame: Overall Study ]
    Best overall response according to RECIST criteria J Natl Cancer Inst 2000;92:205-16


Enrollment: 9
Study Start Date: April 2008
Study Completion Date: April 2009
Primary Completion Date: April 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Zalutumumab 8 mg/kg
Zalutumumab in combination with Irinotecan
Drug: Zalutumumab
Solution for infusion
Other Name: HuMax-EGFr
Experimental: Zalutumumab 16 mg/kg
Zalutumumab in combination with Irinotecan
Drug: Zalutumumab
Solution for infusion
Other Name: HuMax-EGFr

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00677924


Locations
Belgium
Institut Jules Bordet
Brussels, Belgium, 1000
Hospital Erasme
Brussels, Belgium, 1070
St-Luc University Hospital
Brussels, Belgium, 1200
Sponsors and Collaborators
Genmab
Investigators
Study Director: Hassan Aladdin, ICTM Genmab
  More Information

Publications:
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)

Responsible Party: Genmab
ClinicalTrials.gov Identifier: NCT00677924     History of Changes
Other Study ID Numbers: GEN206
First Submitted: May 13, 2008
First Posted: May 15, 2008
Results First Submitted: September 12, 2011
Results First Posted: December 23, 2011
Last Update Posted: December 23, 2011
Last Verified: November 2011

Keywords provided by Genmab:
Colorectal Neoplasms
Colorectal Tumors
Colorectal Carcinoma

Additional relevant MeSH terms:
Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases
Irinotecan
Cetuximab
Antibodies, Monoclonal
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Topoisomerase I Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Immunologic Factors
Physiological Effects of Drugs