Back to resultsGlivec® Plus m-FOLFOX Avastin® in Advanced Colorectal Cancer
Primary Purpose
Advanced Colorectal Cancer
Status
Terminated
Phase
Phase 1
Locations
Australia
Study Type
Interventional
Intervention
Imatinib, Fluorouracil, Oxaliplatin, Leucovorin and Bevacizumab
Sponsored by
About this trial
This is an interventional treatment trial for Advanced Colorectal Cancer focused on measuring Colorectal,, Cancer
Eligibility Criteria
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
Sites / Locations
- Novarts Investigative Site
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Glivec®, modified FOLFOX, Avastin®
Arm Description
Outcomes
Primary Outcome Measures
Tumour response as assessed by CT scan and RESIST
Secondary Outcome Measures
Full Information
NCT ID
NCT01271166
First Posted
January 4, 2011
Last Updated
January 5, 2011
Sponsor
Novartis Pharmaceuticals
1. Study Identification
Unique Protocol Identification Number
NCT01271166
Brief Title
Glivec® Plus m-FOLFOX Avastin® in Advanced Colorectal Cancer
Study Type
Interventional
2. Study Status
Record Verification Date
January 2011
Overall Recruitment Status
Terminated
Study Start Date
October 2007 (undefined)
Primary Completion Date
August 2009 (Actual)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
Novartis Pharmaceuticals
4. Oversight
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Advanced Colorectal Cancer
Keywords
Colorectal,, Cancer
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
10 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Glivec®, modified FOLFOX, Avastin®
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
Imatinib, Fluorouracil, Oxaliplatin, Leucovorin and Bevacizumab
Primary Outcome Measure Information:
Title
Tumour response as assessed by CT scan and RESIST
Time Frame
6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Novartis Pharmaceuticals
Organizational Affiliation
Novartis Pharmaceuticals
Official's Role
Study Director
Facility Information:
Facility Name
Novarts Investigative Site
City
Melbourne
Country
Australia
12. IPD Sharing Statement
Learn more about this trial
Glivec® Plus m-FOLFOX Avastin® in Advanced Colorectal Cancer
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