Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Amgen
Age
18–any
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
Man or woman at least 18 years old
Diagnosis of metastatic colorectal cancer (mCRC)
One and only one chemotherapy regimen for mCRC consisting of first-line 5-FU -based chemotherapy
Radiologically documented disease progression per modified Response Evaluation Criteria in Solid Tumors (RECIST) criteria during treatment or within 6 months of last dose of first-line chemotherapy
At least 1 uni-dimensionally measurable lesion of at least 20 mm per modified RECIST
Eastern Cooperative Oncology Group (ECOG) status of 0, 1, or 2
Paraffin-embedded tumor tissue from the primary tumor or metastasis available for central analyses
Adequate hematologic, renal, and hepatic functions
Negative pregnancy test within 72 hours of enrollment
Other protocol-specified criteria may apply
You may not be if
History of or known presence of central nervous system (CNS) metastases
History of another primary cancer within 5 years of randomization
Prior irinotecan therapy
Prior anti-epidermal growth factor receptor (EGFr) antibody therapy or treatment with small molecule EGFr inhibitors
Any investigational agent or therapy within 30 days before randomization
Known allergy or hypersensitivity to irinotecan, 5-FU or leucovorin
History of interstitial lung disease or evidence of interstitial lung disease on baseline chest computed tomography (CT) scan
Active inflammatory bowel disease or other bowel disease causing chronic diarrhea
Known positive tests for human immunodefiency virus (HIV), hepatitis C viris (HCV), acute or chronic active hepatitis B virus (HBV)
Major surgery within 28 days of randomization or minor surgical procedure within 14 days of randomization
Pregnant or breast-feeding
Man or woman of child-bearing potential not consenting to use adequate contraceptive methods or abstinence during the course of the study and for 6 months after last study drug administration (women) or 1 month after last study drug administration (men)
Other protocol-specified criteria may apply
Clareo Health | Comparison of Treatment Effect of Chemotherapy With Panitumumab to Chemotherapy Alone
