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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


Phase 1/Phase 2
18 Years
N/A
Not Enrolling
Both
Colorectal Cancer

Thank you

Trial Information

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


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

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Adverse Events

Outcome Description:

Number of patients experiencing an adverse event

Outcome Time Frame:

Overall Study

Safety Issue:

Yes

Principal Investigator

Hassan Aladdin, ICTM

Investigator Role:

Study Director

Investigator Affiliation:

Genmab

Authority:

Belgium: Federal Agency for Medicinal Products and Health Products

Study ID:

GEN206

NCT ID:

NCT00677924

Start Date:

April 2008

Completion Date:

April 2009

Related Keywords:

  • Colorectal Cancer
  • Colorectal Neoplasms
  • Colorectal Tumors
  • Colorectal Carcinoma
  • Colorectal Neoplasms

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