A Study of Dulanermin Administered in Combination With Camptosar®/Erbitux® Chemotherapy or FOLFIRI (With or Without Bevacizumab) in Subjects With Previously Treated Metastatic Colorectal Cancer
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 Form
Age \>= 18 years
Histologically confirmed CRC with evidence of metastases and measurable tumor lesion(s)
Progression of disease following, or intolerance to, treatment with 5-fluorouracil-based therapy
Progression of disease during or within =\< 6 months following the last dose of a prior first-line treatment with a fluoropyrimidine and oxaliplatin-based chemotherapy plus bevacizumab for metastatic disease
Use of an effective means of contraception for women of childbearing potential and men with partners of childbearing potential (use per institutional standard)
Life expectancy of \> 3 months
Willingness and capability to be accessible for study follow-up
You may not be if
Prior radiotherapy to a measurable, metastatic lesion(s) to be used to measure response
Radiation therapy to a peripheral lesion within 14 days prior to Day 1; Radiation therapy to a thoracic, abdominal or pelvic field within 28 days prior to Day 1
Chemotherapy, hormonal therapy, or immunology within 4 weeks prior to Day 1
Previous exposure to DR4-targeted therapy or DR5-targeted therapy
Evidence of clinically detectable ascites on Day
Other invasive malignancies within 5 years prior to Day 1 (other than basal cell carcinoma of the skin or in situ carcinoma of the cervix)
History or evidence upon physical examination of CNS disease
Active infection requiring parenteral antibiotics on Day 1
Major surgical procedure, open biopsy, or significant traumatic injury within 28 days prior to Day 1 or anticipation of need for major surgical procedure during the course of the study and fine needle aspirations within 7 days prior to Day 1
Pregnancy or lactation
Serious nonhealing wound, ulcer, or bone fracture
Current or recent participation in another experimental drug study
Clinically significant cardiovascular disease
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 that might affect interpretation of the results of the study or render the subject at high risk from treatment complications
Cohort 5 only: Subjects who have a Kras mutation will be excluded from enrollment
Clareo Health | A Study of Dulanermin Administered in Combination With Camptosar®/Erbitux® Chemotherapy or FOLFIRI (With or Without Bevacizumab) in Subjects With Previously Treated Metastatic Colorectal Cancer
