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TerminatedNCT01271166Updated Jan 6, 2011

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

A Phase 1 interventional study of Imatinib, Fluorouracil, Oxaliplatin, Leucovorin and Bevacizumab in Advanced Colorectal Cancer, sponsored by Novartis Pharmaceuticals. Terminated at 1 site in Australia. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2011-01-06.

Sponsored by Novartis Pharmaceuticals · Phase 1, Interventional, and Treatment

Phase
Phase 1
Study type
Interventional
Enrollment
10
Allocation
Not applicable
Ages
18 Years and older
Sex
All
01

Study 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.

02

Conditions studied

  • Advanced Colorectal Cancer

Keywords

  • Colorectal,
  • Cancer
03

In context

Colorectal Neoplasms

5,599 studies on the registry are indexed under Colorectal Neoplasms; 1,459 are open to participants now.

This study's enrollment of 10 is below the median of 77 across 4,123 interventional studies indexed under Colorectal Neoplasms.

Browse Colorectal Neoplasms studies →

Lead sponsor

Novartis Pharmaceuticals is the lead sponsor of 2,673 studies on the registry; 228 are open to participants now.

Of its 576 completed or terminated interventional studies of FDA-regulated products, 431 (75%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • Histologically confirmed, locally advanced, recurrent or metastatic colorectal cancer
  • ECOG 0 or 1
  • Measurable disease

Exclusion criteria

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

05

Study design

Phase
Phase 1
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
10 participants (actual)

Study arms

  • Experimental
    Glivec®, modified FOLFOX, Avastin®

    Drug: Imatinib, Fluorouracil, Oxaliplatin, Leucovorin and Bevacizumab

Interventions

  • DrugImatinib, Fluorouracil, Oxaliplatin, Leucovorin and Bevacizumab
06

What researchers measure

Primary outcomes

  1. Tumour response as assessed by CT scan and RESIST

    Time frame: 6 months

07

Study locations

1 site
  • Novarts Investigative Site
    Melbourne, Australia
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 6, 2011, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT01271166
Lead sponsor
Novartis Pharmaceuticals
First posted
Jan 6, 2011
Start date
Oct 2007
Primary completion
Aug 2009
Last update
Jan 6, 2011

Study contacts

Novartis Pharmaceuticals
study director · Novartis Pharmaceuticals
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is terminated, as verified in Jan 2011. You cannot join it, but the record below documents what was studied.

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