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

Completed · Phase 1

Conditions studied: Colorectal Cancer, Colorectal Carcinoma, Colorectal Tumors, Neoplasms, Colorectal

In brief

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

Key facts

Study ID

NCT00478634

Run by

Novartis Pharmaceuticals

People needed

19

Starts

2007-05-01

Expected to finish

2009-09-01

Last updated by the study team

2012-11-02

Who can join

Age: 18 and older, up to 65. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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

Where it is running

• Highlands Oncology Group — Fayetteville, Arkansas, United States
• Comprehensive nBlood and Cancer Care — Bakersfield, California, United States
• UCSD - Moores Cancer Center — La Jolla, California, United States
• Comprehensive Cancer Care — Los Angeles, California, United States
• North Valley Hematology/Oncology Medical Group: The Thomas & Dorothy Leavey Cancer Center — Northridge, California, United States
• Cancer Care Associates Medical Group, Inc. — Redondo Beach, California, United States
• Norwalk Hospital — Norwalk, Connecticut, United States
• Gerogetown University Lombardi Cancer Center — Washington D.C., District of Columbia, United States
• H. Lee Moffitt Cancer Center — Tampa, Florida, United States
• Oncology Specialists — Park Ridge, Illinois, United States
• Nevada Cancer Institute — Las Vegas, Nevada, United States
• Roswell Park Cancer Institute — Buffalo, New York, United States
• Richmond University Medical Center — Staten Island, New York, United States
• UNC School of Medicine — Chapel Hill, North Carolina, United States
• Oncology/Hematology Associates — Bethlehem, Pennsylvania, United States
• Arlington Cancer Center — Arlington, Texas, United States

Full record on ClinicalTrials.gov

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