Lead Sponsor

Novartis Pharmaceuticals

Age

18 - 65 years

Sex

ALL

Healthy Volunteers

No

•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.

•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.

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