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Imaging HSP90 Inhibitor AUY922 on VEGF-89ZR-bevacizumab Positron Emission Tomography (PET)

NCT ID: NCT01081613

Last Updated: 2012-09-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

7 participants

Study Classification

OBSERVATIONAL

Study Start Date

2010-02-28

Study Completion Date

2012-02-29

Brief Summary

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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.

Detailed Description

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This feasibility study is designed as a side study to the multicenter, international phase I-II trial with HSP90 inhibitor AUY922 (protocol CAUY922A2101), as part of the biomarker assessment. In protocol CAUY922A2101, section 4, the design of this phase I-II trial is described (p37, 38). Briefly, a dose-escalation study is performed according to phase I design in adult patients with advanced solid malignancies. This part is followed by a dose-expansion study according to a phase II design. In the latter part, breast cancer patients are enrolled that are either refractory to hormone- or trastuzumab treatment (both treatment arms, n=40 patients), on the maximal tolerated dose of AUY922 based on the phase I part of the study. Patients with ER positive, hormone therapy refractory breast cancer, will receive a 89Zr-bevacizumab PET scan as part of the present side study protocol, which will be performed in collaboration with the Royal Marsden Hospital (United Kingdom).

To this end, a 89Zr-bevacizumab PET scan will be performed before (baseline) and during treatment with HSP90 inhibitor AUY922, as described below.

A minimum of six patients will be entered to evaluate whether the effect of HSP90 inhibition by AUY922 can be detected with a 89Zr-bevacizumab PET scan

Conditions

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Breast Cancer

Keywords

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heat shock protein breast cancer PET imaging bevacizumab

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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AUY922

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

89Zr-bevacizumab PET imaging

Intervention Type OTHER

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

Interventions

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89Zr-bevacizumab PET imaging

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

Intervention Type OTHER

Other Intervention Names

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89Zr-bevacizumab

Eligibility Criteria

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Inclusion Criteria

* patients with ER positive, hormone therapy refractory breast cancer

Exclusion Criteria

* no participation in the phase I-II trial with HSP90 inhibitor AUY922
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University Medical Center Groningen

OTHER

Sponsor Role lead

Responsible Party

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C.P. Schroder

PhD

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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C.P. Schröder, PhD

Role: PRINCIPAL_INVESTIGATOR

University Medical Center Groningen

Locations

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University Medical Center Groningen

Groningen, Provincie Groningen, Netherlands

Site Status

Countries

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Netherlands

Other Identifiers

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2008-005752-25

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

CAUY922A2101

Identifier Type: -

Identifier Source: org_study_id