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

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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 )

Study Description

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 Design

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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
Actual Primary Completion Date :	July 2012
Actual Study Completion Date :	July 2012

Resource links provided by the National Library of Medicine

Genetics Home Reference related topics: Breast cancer

MedlinePlus related topics: Breast Cancer

Drug Information available for: Vinorelbine Vinorelbine tartrate Imatinib Imatinib mesylate

U.S. FDA Resources

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures :

Maximum tolerated dose (MTD) [ Time Frame: at least 28 days ]

Eligibility Criteria

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Ages Eligible for Study:	18 Years and older (Adult, Older Adult)
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

Contacts and Locations

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

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Germany
Novartis Investigative Site
Kiel, Germany, 24105

Sponsors and Collaborators

Novartis Pharmaceuticals

Investigators

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Study Director:	Novartis Pharmaceuticals	Novartis Pharmaceuticals
Study Director:	Novartis Pharmaceuticals	Novartis Pharmeceuticals

More Information

Additional Information:

Results for CSTI571BDE28 from the Novartis Clinical Trials website This link exits the ClinicalTrials.gov site

Publications of Results:

Maass N, Schem C, Bauerschlag DO, Tiemann K, Schaefer FW, Hanson S, Muth M, Baier M, Weigel MT, Wenners AS, Alkatout I, Bauer M, Jonat W, Mundhenke C. Final safety and efficacy analysis of a phase I/II trial with imatinib and vinorelbine for patients with metastatic breast cancer. Oncology. 2014;87(5):300-10. doi: 10.1159/000365553. Epub 2014 Aug 26.

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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:

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

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