Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 3:04 PM
Ignite Modification Date:
2025-12-24 @ 3:04 PM
NCT ID:
NCT03368859
Eligibility Criteria:
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.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT03368859
Study Brief:
Protocol Section:
NCT03368859