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Efficacy and Safety of Imatinib and Vinorelbine in Patients With Advanced Breast Cancer (INV181)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00372476
Recruitment Status : Completed
First Posted : September 7, 2006
Last Update Posted : February 7, 2017
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )

Brief Summary:
This study is designed to investigate the safety and efficacy of the combination of imatinib and vinorelbine in patients with advanced, anthracycline resistant breast cancer

Condition or disease Intervention/treatment Phase
Breast Cancer Drug: Imatinib and Vinorelbine Phase 4

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 33 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Open-label Trial of Imatinib in Combination With Vinorelbine for Patients With Advanced Breast Carcinoma: ICON
Study Start Date : June 2006
Primary Completion Date : July 2012
Study Completion Date : July 2012

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer
U.S. FDA Resources

Arm Intervention/treatment
Experimental: Imatinib + Vinorelbine Drug: Imatinib and Vinorelbine



Primary Outcome Measures :
  1. Maximum tolerated dose (MTD) [ Time Frame: at least 28 days ]


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:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion criteria:

  • Histologically documented diagnosis of invasive breast cancer that is locally advanced or metastatic
  • Previous anthracycline containing chemotherapy
  • Presence of a certain protein on the cell surface (c-kit (CD117) and /or PDGF-receptor)
  • Preferably tumor samples should be taken within 6 weeks of study entry. Most recent primary tumor tissue has to be available for analysis
  • Acceptable health status (Eastern Cooperative Oncology Group [ECOG]-performance status 0,1, 2 or 3)

Exclusion criteria: (for the second-line therapy)

  • Patient with Grade III/IV cardiac problems (i.e., congestive heart failure, myocardial infarction within 6 months of study) and with severe and/or uncontrolled medical disease (i.e., uncontrolled diabetes, chronic renal disease, or active uncontrolled infection).
  • Patient has a known brain metastasis, chronic liver disease (i.e., chronic active hepatitis, and cirrhosis) and diagnosis of (HIV) infection.
  • Patient received chemotherapy within 4 weeks prior to study entry, unless the disease is rapidly progressing.
  • Patient previously received radiotherapy to ≥ 25 % of the bone marrow and had a major surgery within 2 weeks prior to study entry.
  • Patient received either Vinorelbine or Imatinib in previous treatment regimens

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): NCT00372476


Locations
Germany
Novartis Investigative Site
Kiel, Germany, 24105
Sponsors and Collaborators
Novartis Pharmaceuticals
Investigators
Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals
Study Director: Novartis Pharmaceuticals Novartis Pharmeceuticals

Additional Information:
Publications:
Responsible Party: Novartis Pharmaceuticals
ClinicalTrials.gov Identifier: NCT00372476     History of Changes
Other Study ID Numbers: CSTI571BDE28
2005-001537-15
First Posted: September 7, 2006    Key Record Dates
Last Update Posted: February 7, 2017
Last Verified: February 2017

Keywords provided by Novartis ( Novartis Pharmaceuticals ):
Breast cancer
Tyrosine inhibitor
Chemotherapy
Imatinib

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Vinorelbine
Imatinib Mesylate
Vinblastine
Antineoplastic Agents
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents, Phytogenic
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators