Predicting Response and Toxicity in Patients Receiving Lonafarnib for Breast Cancer

This study has been terminated.

(funding terminated)

Sponsor:

Collaborators:

Department of Defense

Indiana University School of Medicine

Emory University

Information provided by:

Hoosier Oncology Group

ClinicalTrials.gov Identifier:

NCT01232881

First received: November 1, 2010

Last updated: April 27, 2011

Last verified: April 2011

History of Changes

Tracking Information

First Received Date ^ICMJE

November 1, 2010

Last Updated Date

April 27, 2011

Start Date ^ICMJE

August 2009

Primary Completion Date

November 2010 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

To correlate tumor gene expression (genomic profile) with response to lonafarnib in patients with advanced breast cancer [ Time Frame: 24 months ] [ Designated as safety issue: No ]

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT01232881 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

To correlate serum and tumor proteomic profiles with response to lonafarnib [ Time Frame: 24 months ] [ Designated as safety issue: No ]
To compare serum and tissue proteomic analyses [ Time Frame: 24 months ] [ Designated as safety issue: No ]
To compare genomic and proteomic profiles [ Time Frame: 24 months ] [ Designated as safety issue: No ]
To correlate toxicity and /or response with drug-specific pharmacogenomic parameters [ Time Frame: 24 months ] [ Designated as safety issue: Yes ]

Original Secondary Outcome Measures ^ICMJE

Same as current

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

Predicting Response and Toxicity in Patients Receiving Lonafarnib for Breast Cancer

Official Title ^ICMJE

Predicting Response and Toxicity in Patients Receiving Lonafarnib for Breast Cancer: A Multicenter Genomic, Proteomic and Pharmacogenomic Correlative Study

Brief Summary

This is a tumor and serum collection study for patients with advanced breast cancer receiving treatment with lonafarnib.

Detailed Description

OUTLINE: This is a multi-center study.

Sample Collection:

Tumor sample
Serum sample

Treatment Regimen:

All registered patients must be planning treatment with lonafarnib

Study Type ^ICMJE

Observational

Study Design ^ICMJE

Time Perspective: Prospective

Target Follow-Up Duration

Not Provided

Biospecimen

Retention: Samples Without DNA

Description:

Tumor sample submission can consist of a fresh frozen tissue sample or a formalin-fixed paraffin embedded tissue block.

Serum is to be collected prior to the initiation of lonafarnib treatment and 28 days after the last dose of lonafarnib.

Sampling Method

Probability Sample

Study Population

The study population will be limited to patients with advanced breast cancer receiving treatment with lonafarnib.

Condition ^ICMJE

Breast Cancer

Intervention ^ICMJE

Procedure: Tumor Sample
Tumor sample submission can consist of a fresh frozen tissue sample or a formalin-fixed paraffin embedded tissue block.
Procedure: Serum Sample
Serum is to be collected prior to the initiation of lonafarnib treatment and 28 days after the last dose of lonafarnib.

Study Group/Cohort (s)

Tumor and Serum Collection

Tumor sample submission can consist of a fresh frozen tissue sample or a formalin-fixed paraffin embedded tissue block.

Serum is to be collected prior to the initiation of lonafarnib treatment and 28 days after the last dose of lonafarnib.

Interventions:

Procedure: Tumor Sample
Procedure: Serum Sample

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Terminated

Enrollment ^ICMJE

Completion Date

November 2010

Primary Completion Date

November 2010 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

Inclusion Criteria:

Written informed consent and HIPAA authorization for release of personal health information. NOTE: HIPAA authorization may be included in the informed consent or obtained separately.
Age > 18 years.
Planned treatment with lonafarnib for metastatic breast cancer.
Must consent to have a biopsy performed to obtain fresh tissue or be able to identify a formalin fixed paraffin embedded (FFPE) tissue block in which tumor samples can be obtained to complete the testing for this study.

Exclusion Criteria:

Planned treatment with any other treatment regimen

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States

Administrative Information

NCT Number ^ICMJE

NCT01232881

Other Study ID Numbers ^ICMJE

HOG COE-03

Has Data Monitoring Committee

Yes

Responsible Party

George Sledge, M.D., Hoosier Oncology Group

Study Sponsor ^ICMJE

Hoosier Oncology Group

Collaborators ^ICMJE

Department of Defense
Indiana University School of Medicine
Emory University

Investigators ^ICMJE

Study Chair:

George Sledge, M.D.

Hoosier Oncology Group

Information Provided By

Hoosier Oncology Group

Verification Date

April 2011

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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