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

Novartis

Status and phase: Terminated; Phase 1

Conditions: Advanced Colorectal Cancer

Treatments: Drug: Imatinib, Fluorouracil, Oxaliplatin, Leucovorin and Bevacizumab

Study type: Interventional

Funder types: Industry

Identifiers

NCT01271166

CSTI571BAU14

Details and patient eligibility

About

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.

Enrollment: 10 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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10 participants in 1 patient group

Glivec®, modified FOLFOX, Avastin®

Experimental group

Treatment:

Drug: Imatinib, Fluorouracil, Oxaliplatin, Leucovorin and Bevacizumab