Glivec® Plus m-FOLFOX Avastin® in Advanced Colorectal Cancer

• Status: Terminated
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: All

Summary

This is a Phase I, dose finding, multicentre study evaluating the maximal tolerated dose of Glivec® in combination with mFOLFOX-Avastin®. Patients will be enrolled into each dose level in 3 patient cohorts. Additional cohorts will be enrolled, or dose levels opened, subject to the toxicities observed. Once the MTD has been determined the dose level below will be re-opened and extra patients, to a total of 15, will be enrolled.

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

Details

• Lead Sponsor: Novartis Pharmaceuticals
• Treatments: Bevacizumab; Fluorouracil; Imatinib Mesylate; Leucovorin; Oxaliplatin

Criteria

Inclusion Criteria:

• Histologically confirmed, locally advanced, recurrent or metastatic colorectal cancer

• ECOG 0 or 1

• Measurable disease

Exclusion Criteria:

• Prior first line therapy for advanced disease

• Significant bulk of metastatic disease or rapid progression

• If prior adjuvant therapy, relapse within 6 months of a 5-FU based regimen or 12 months of an oxaliplatin based regimen

Other protocol-defined inclusion/exclusion criteria may apply