- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01271166
Glivec® Plus m-FOLFOX Avastin® in Advanced Colorectal Cancer
January 5, 2011 updated by: Novartis Pharmaceuticals
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 Overview
Status
Terminated
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
10
Phase
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Melbourne, Australia
- Novarts Investigative Site
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Glivec®, modified FOLFOX, Avastin®
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Tumour response as assessed by CT scan and RESIST
Time Frame: 6 months
|
6 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
October 1, 2007
Primary Completion (Actual)
August 1, 2009
Study Registration Dates
First Submitted
January 4, 2011
First Submitted That Met QC Criteria
January 5, 2011
First Posted (Estimate)
January 6, 2011
Study Record Updates
Last Update Posted (Estimate)
January 6, 2011
Last Update Submitted That Met QC Criteria
January 5, 2011
Last Verified
January 1, 2011
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Digestive System Diseases
- Neoplasms
- Neoplasms by Site
- Gastrointestinal Neoplasms
- Digestive System Neoplasms
- Gastrointestinal Diseases
- Colonic Diseases
- Intestinal Diseases
- Intestinal Neoplasms
- Rectal Diseases
- Colorectal Neoplasms
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Enzyme Inhibitors
- Antimetabolites, Antineoplastic
- Antimetabolites
- Antineoplastic Agents
- Immunosuppressive Agents
- Immunologic Factors
- Protective Agents
- Antineoplastic Agents, Immunological
- Angiogenesis Inhibitors
- Angiogenesis Modulating Agents
- Growth Substances
- Growth Inhibitors
- Micronutrients
- Protein Kinase Inhibitors
- Vitamins
- Antidotes
- Vitamin B Complex
- Fluorouracil
- Oxaliplatin
- Bevacizumab
- Leucovorin
- Imatinib Mesylate
Other Study ID Numbers
- CSTI571BAU14
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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