Colorectal Cancer
Conditions
Keywords
Metastatic Colorectal Cancer, Colon, Colorectal, Rectal Cancer, EGFr, Metastatic, Cancer, ABX-EGF, Panitumumab, Clinical Trial, Immunex, Abgenix, Amgen
Brief summary
The purpose of this study is to examine the safety of ABX-EGF administered as monotherapy in subjects with metastatic colorectal cancer who were previously randomized to best supportive care (BSC) in protocol 20020408 and subsequently determined to have progressive disease.
Interventions
DRUGABX-EGF
Sponsors
Amgen
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
- Subject previously randomized to BSC in protocol 20020408 and subsequently 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Incidence of Adverse events | — |
| Changes in Lab values | — |
| Incidence of HAHA formation | — |
Outcome results
None listed