A Phase 1 Study Investigating the Combination of RAD001, Cetuximab and Irinotecan as Second-line Therapy After FOLFOX (or XELOX) Plus Bevacizumab in Patients With Metastatic Colorectal Cancer

• Status: Completed
• Trial end date: 2009-09-01
• Target enrollment: 0
• Participant gender: All

Summary

This study will assess the safety of RAD001 when given together with cetuximab and irinotecan

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Novartis Pharmaceuticals
• Treatments: Bevacizumab; Camptothecin; Cetuximab; Everolimus; Irinotecan; Sirolimus

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