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:
2025-12-25 @ 2:24 AM
Ignite Modification Date:
2025-12-25 @ 2:24 AM
NCT ID:
NCT00478634
Eligibility Criteria:
Inclusion criteria:
* Age ≥ 18 years old and ≤ 65 years old.
* Patients with metastatic CRC. Confirmation of CRC diagnosis by histological or cytological specimen from original resection of primary tumor.
* Patients who progressed despite prior therapy with FOLFOX (5FU and oxaliplatin) plus bevacizumab or XELOX (capecitabine and oxaliplatin) plus bevacizumab.
* Patients with at least one measurable lesion by RECIST as determined by Computer Tomography (CT) Scan, Magnetic Resonance Imaging (MRI) or physical examination.
* Patients with a WHO performance status of 0 or 1.
Exclusion criteria:
* Patients with Gilbert's syndrome or any other syndrome associated with deficient glucoronidation of bilirubin.
* Patients who are homozygous for the UGT1A1\*28 allele as determined by sequencing.
* Patients who have received previous irinotecan-based therapy.
* Prior treatment with an mTOR inhibitor.
Other protocol-defined inclusion/exclusion criteria may apply
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
65 Years
Study:
NCT00478634
Study Brief:
Protocol Section:
NCT00478634