NCT01081613

Brief Summary

Inhibition of Heat Shock Protein (HSP)90 is a new, promising treatment modality for cancer patients, particularly in the setting of resistance. A reliable read out system (biomarker) for the evaluation of early treatment effect is of great importance in the development of this treatment modality, and could contribute to customize this treatment for individual patients. So far, no reliable biomarker has been described for HSP90 effect. Visualizing the effect of HSP90 on vascular endothelial growth factor (VEGF) secretion in vivo in the patient, by whole body 89Zr-bevacizumab uptake, can be of great importance in this respect, and may contribute to tailored made cancer treatment. The purpose of the present study is to evaluate the effect of HSP90 inhibition by AUY922 on VEGF by means of 89ZR-bevacizumab PET.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
7

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Feb 2010

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2010

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

March 4, 2010

Completed
1 day until next milestone

First Posted

Study publicly available on registry

March 5, 2010

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2012

Completed
Last Updated

September 6, 2012

Status Verified

September 1, 2012

Enrollment Period

2 years

First QC Date

March 4, 2010

Last Update Submit

September 5, 2012

Conditions

Keywords

heat shock proteinbreast cancerPET imagingbevacizumab

Outcome Measures

Primary Outcomes (1)

  • To evaluate the effect of HSP90 inhibition by AUY922 on VEGF by means of 89Zr-bevacizumab PET.

    Primary endpoint: measurement of decreased VEGF compared to baseline. A decline is defined as a decrease of at least 30% in mean Standardized Uptake Value (SUV) in a maximum of three lesions.

    2 years

Study Arms (1)

AUY922

Patients with estrogen receptor (ER) positive, hormone therapy refractory breast cancer.

Other: 89Zr-bevacizumab PET imaging

Interventions

injection 89Zr-bevacizumab and 89 Zr-bevacizumab PET scan

Also known as: 89Zr-bevacizumab
AUY922

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Patients with ER positive, hormone therapy refractory breast cancer, who are participating in the phase I-II trial with HSP90 inhibitor AUY922

You may qualify if:

  • patients with ER positive, hormone therapy refractory breast cancer

You may not qualify if:

  • no participation in the phase I-II trial with HSP90 inhibitor AUY922

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Medical Center Groningen

Groningen, Provincie Groningen, 9713 GZ, Netherlands

Location

MeSH Terms

Conditions

Breast Neoplasms

Interventions

89Zr-bevacizumab

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Study Officials

  • C.P. Schröder, PhD

    University Medical Center Groningen

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PhD

Study Record Dates

First Submitted

March 4, 2010

First Posted

March 5, 2010

Study Start

February 1, 2010

Primary Completion

February 1, 2012

Study Completion

February 1, 2012

Last Updated

September 6, 2012

Record last verified: 2012-09

Locations