Clareo Health | A Study of PRO95780 in Combination With Cetuximab and Irinotecan Chemotherapy or the FOLFIRI Regimen With Bevacizumab in Patients With Previously Treated Metastatic Colorectal Cancer (APM4187g)
A Study of PRO95780 in Combination With Cetuximab and Irinotecan Chemotherapy or the FOLFIRI Regimen With Bevacizumab in Patients With Previously Treated Metastatic Colorectal Cancer (APM4187g)
Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Genentech, Inc.
Age
18–any
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
Signed informed consent
Age ≥ 18 years
Histologically confirmed CRC with evidence of metastases and measurable tumor lesions
Documented disease progression following, or intolerance to, treatment with 5-fluorouracil, oxaliplatin, and bevacizumab-based therapy
Life expectancy \> 3 months
For patients of reproductive potential (males and females), use of reliable means for contraception (e.g., contraceptive pill, intrauterine device \[IUD\], physical barrier) throughout the trial and for 6 months following their final exposure to study treatment
Willingness and capability to be accessible for study follow-up
You may not be if
Patients who have a Kras mutation will be excluded from receiving cetuximab-containing regimens
Prior radiotherapy to a measurable metastatic lesion(s) to be used for response assessment, unless the lesion has progressed subsequent to the radiotherapy
Recent radiotherapy to a peripheral lesion, thoracic, abdominal, or pelvic field
Recent chemotherapy, hormonal therapy, or immunotherapy
Evidence of clinically detectable ascites
Other invasive malignancies within 5 years
History or evidence of active central nervous system (CNS) disease
Current or recent participation in another experimental drug study
Clinically significant cardiovascular disease
Active infection requiring parenteral antibiotics
Recent major surgical procedure, open biopsy, significant traumatic injury, fine needle aspirations, or anticipation of need for major surgical procedure during the course of the study
Known or suspected to be positive for the human immunodeficiency virus (HIV)
Known to be positive for hepatitis C or hepatitis B surface antigen
History of other disease, metabolic dysfunction, physical examination finding, or clinical laboratory finding giving reasonable suspicion of a disease or condition that contraindicates use of an investigational drug or specified study treatment
Pregnancy (positive pregnancy test) or breast feeding
Serious, non-healing wound, ulcer, or bone fracture
Known sensitivity to any of the products administered during the study
Any disorder that compromises the ability of the patient to provide written informed consent and/or comply with study procedures
