NCT03368859
Brief summary
A study to evaluate the efficacy and tolerability of an active drug plus FOLFIRI compared to bevacizumab plus FOLFIRI in participants with previously treated metastatic adenocarcinoma of the colon or rectum.
Interventional study
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Please note, participation in the clinical trial is open to patients with the disease or condition under investigation. |
Age:
18 Years and older.
Inclusion Criteria:
- Diagnosis of histologically or cytologically confirmed metastatic adenocarcinoma of
the colon or rectum.
- Primary tumor has been resected > 3 months prior to randomization.
- At least 1 lesion on a computed tomography (CT) scan (preferred) or magnetic resonance
imaging (MRI) that is measurable as defined by Response Evaluation Criteria In Solid
Tumors (RECIST), Version 1.1.
- Eastern Cooperative Oncology Group (ECOG) performance score of 0 or 1.
- Progression following treatment with fluoropyrimidine/oxaliplatin/bevacizumab-regimen
in the metastatic setting.
- Adequate hematologic, renal and hepatic function.
Exclusion Criteria:
- Any prior therapy with irinotecan
- Unresolved clinically significant toxicities from prior anticancer therapy, defined as
any Common Terminology Criteria for Adverse Events (CTCAE) => Grade 2
- Clinically significant conditions that increase the risk for antiangiogenic therapy.
- History of any of the following during first-line therapy with a
bevacizumab-containing regimen: arterial thrombotic/thromboembolic event, bowel
perforation, Grade 4 hypertension, Grade 3 proteinuria or Grade 3 - 4 bleeding event.
