A Multicenter, Open-label, Single Arm Clinical Trial to Determine the Safety of ABX-EGF Extended Therapy in Subjects With Metastatic Colorectal Cancer
Phase 2
18 Years
N/A
18 Years
N/A
Not Enrolling
Both
Colorectal Cancer
Both
Colorectal Cancer
Trial Information
A Multicenter, Open-label, Single Arm Clinical Trial to Determine the Safety of ABX-EGF Extended Therapy in Subjects With Metastatic Colorectal Cancer
Inclusion Criteria:
- Subject previously randomized to BSC in protocol 20020408 andsubsequently determined to have progressive disease - ECOG performance status of 0, 1 or 2
- Adequate hematologic, renal and hepatic function Exclusion Criteria: - Myocardial
infarction in time interval between completing 20020408 and enrollment in study - History
or evidence of interstitial pneumonitis or pulmonary fibrosis - Prior anti-tumor therapies
including prior experimental agents or approved anti-tumor small molecules and biologics
during the time interval between completing 20020408 protocol and enrollment in this study
- Use of systemic chemotherapy or radiotherapy during the time interval between completing
20020408 protocol and enrollment in this study
Type of Study:
Interventional
Study Design:
Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
Incidence of Adverse events
Principal Investigator
MD
Investigator Role:
Study Director
Investigator Affiliation:
Amgen
Authority:
United States: Food and Drug Administration
Study ID:
20030194
NCT ID:
NCT00113776
Start Date:
Completion Date:
Related Keywords:
- Colorectal Cancer
- Metastatic Colorectal Cancer, Colon
- Colorectal, Rectal Cancer, EGFr
- Metastatic, Cancer, ABX-EGF
- Panitumumab, Clinical Trial
- Immunex, Abgenix, Amgen
- Colorectal Neoplasms
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