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

Advanced Colorectal Cancer Clinical Trial

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01271166
• Other study ID #: CSTI571BAU14
• Status: Terminated
• Phase: Phase 1
• First received: January 4, 2011
• Last updated: January 5, 2011
• Start date: October 2007

Study information

• Verified date: January 2011
• Source: Novartis
• Contact: n/a
• Is FDA regulated: No
• Health authority: Australia: Department of Health and Ageing Therapeutic Goods Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 10
• Est. primary completion date: August 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Advanced Colorectal Cancer
• Colorectal Neoplasms

Intervention

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

Locations

Country	Name	City	State
Australia	Novarts Investigative Site	Melbourne

Sponsors (1)

Lead Sponsor	Collaborator
Novartis Pharmaceuticals

Country where clinical trial is conducted

Australia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Tumour response as assessed by CT scan and RESIST		6 months	No