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

Status

Terminated

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01271166

Enrollment

Registered

2011-01-06

Start date

2007-10-31

Completion date

Unknown

Last updated

2011-01-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Advanced Colorectal Cancer

Keywords

Colorectal,, Cancer

Brief 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.

Interventions

DRUGImatinib, Fluorouracil, Oxaliplatin, Leucovorin and Bevacizumab

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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/

Design outcomes

Primary

Measure	Time frame
Tumour response as assessed by CT scan and RESIST	6 months

Countries

Australia

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026