Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Gilead Sciences
Age
18–any
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
Metastatic colorectal carcinoma with KRAS mutation
Received first line therapy and discontinued part or all of first line therapy
Estimated life expectancy \> 3 months
Stage IV disease
Eastern Cooperative Oncology Group (ECOG) performance status: 0-2
Adequate hepatic and hematologic function
No major operations within 4 weeks prior to treatment start
You may not be if
More than 1 prior chemotherapy regimen for Stage 4 colorectal cancer
Experimental medical treatment within 30 days prior to study entry
Known or suspected cerebral metastases
History or presence of any form of cancer, other that colorectal cancer, within the 3 years prior to enrollment
Known dihydropyrimidine dehydrogenase-deficiency (special screening not required)
Subjects with angina pectoris, poorly controlled ventricular arrhythmias (does not include asymptomatic, occasional premature ventricular contractions), history of clinically significant coronary heart disease or cardiomyopathy, or electrocardiogram (ECG) abnormalities consistent with ischemia
Uncontrolled hypertension (seated systolic blood pressure \> 180 mm Hg or diastolic blood pressure \> 110 mm Hg) at screening
Clinically active liver disease, including active hepatitis (any etiology) or cirrhosis
Anti-tumor therapy (chemotherapy, antibody therapy, molecular targeted therapy, retinoid therapy, hormonal therapy) within 21 days prior to randomization
Prior irinotecan therapy for metastatic disease is not permitted
Systemic fungal, bacterial, viral, or other infection
Clareo Health | Efficacy and Safety of Simtuzumab (SIM) With FOLFIRI as Second Line Treatment in Colorectal Adenocarcinoma