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

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ClinicalTrials.gov Identifier: NCT01271166
Recruitment Status : Terminated
First Posted : January 6, 2011
Last Update Posted : January 6, 2011
Information provided by:

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.

Condition or disease Intervention/treatment Phase
Advanced Colorectal Cancer Drug: Imatinib, Fluorouracil, Oxaliplatin, Leucovorin and Bevacizumab Phase 1

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 10 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Study Start Date : October 2007
Primary Completion Date : August 2009

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Experimental: Glivec®, modified FOLFOX, Avastin® Drug: Imatinib, Fluorouracil, Oxaliplatin, Leucovorin and Bevacizumab

Primary Outcome Measures :
  1. Tumour response as assessed by CT scan and RESIST [ Time Frame: 6 months ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01271166

Novarts Investigative Site
Melbourne, Australia
Sponsors and Collaborators
Novartis Pharmaceuticals
Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals

Responsible Party: External Affairs, Novartis Pharmaceuticals
ClinicalTrials.gov Identifier: NCT01271166     History of Changes
Other Study ID Numbers: CSTI571BAU14
First Posted: January 6, 2011    Key Record Dates
Last Update Posted: January 6, 2011
Last Verified: January 2011

Keywords provided by Novartis:

Additional relevant MeSH terms:
Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Physiological Effects of Drugs
Growth Inhibitors
Antineoplastic Agents
Molecular Mechanisms of Pharmacological Action
Antimetabolites, Antineoplastic
Immunosuppressive Agents
Immunologic Factors