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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
  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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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 ] [ Designated as safety issue: Yes ]
    Number of patients experiencing an adverse event


Secondary Outcome Measures:
  • 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


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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00677924

Locations
Belgium
Hospital Erasme
Brussels, Belgium, 1070
Institut Jules Bordet
Brussels, Belgium, 1000
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
Study First Received: May 13, 2008
Results First Received: September 12, 2011
Last Updated: November 21, 2011
Health Authority: Belgium: Federal Agency for Medicinal Products and Health Products

Keywords provided by Genmab:
Colorectal Neoplasms
Colorectal Tumors
Colorectal Carcinoma

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

ClinicalTrials.gov processed this record on November 20, 2014