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

Phase 1TerminatedNCT01271166

Novartis Pharmaceuticals10 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Advanced Colorectal Cancer

Interventions

Imatinib, Fluorouracil, Oxaliplatin, Leucovorin and BevacizumabDRUG

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

Novarts Investigative Site

Melbourne, Australia

Outcomes

Primary Outcomes

Tumour response as assessed by CT scan and RESIST

Time frame: 6 months

Data from ClinicalTrials.gov

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