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Prediction of Response to Kinase Inhibitors Based on Protein Phosphorylation Profiles in Tumor Tissue From Advanced Renal Cell Cancer Patients

NCT ID: NCT02071719

Last Updated: 2020-11-20

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

TERMINATED

Total Enrollment

6 participants

Study Classification

OBSERVATIONAL

Study Start Date

2012-04-30

Study Completion Date

2017-10-31

Brief Summary

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The rapid development of agents blocking kinases has established the use of molecularly targeted therapy as the preferred treatment approach for patients with metastatic renal cell cancer (RCC). Five kinase inhibitors (sunitinib, everolimus, temsirolimus, sorafenib and pazopanib) are now approved for clinical use. Response rates differ among these agents, importantly depending on line of treatment. In first-line treatment sunitinib results in 47% objective response rates, where in second-line after cytokines 34% responds. Thus far, it is unclear which patient with advanced renal cell cancer will respond to targeted therapy. In order to select patients for targeted therapies, several profiling approaches have been explored but to date no adequate and reliable test is available. It is assumed that responses to targeted agents depend on specific receptor and protein signalling activities in tumor tissues. Therefore, we propose that protein phosphorylation profiling with phosphoproteomics may be a potential clinical diagnostic tool to predict for tumor response to targeted therapy.

Detailed Description

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Conditions

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Renal Cell Cancer

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Sunitinib

No interventions assigned to this group

Sorafenib

No interventions assigned to this group

Everolimus

No interventions assigned to this group

Pazopanib

No interventions assigned to this group

Axitinib

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

* Patients with advanced (unresectable and/or metastatic) renal cell cancer.
* Patients who will start treatment with sunitinib, pazopanib, sorafenib, axitinib or everolimus.
* At least one tumor lesion should be accessible for biopsy. Bone metastases are excluded as possible biopsy site.
* Age \>- 18 years.
* Patients must have at least one measurable lesion. Lesions must be evaluated by CT-scan or MRI according to Response Evaluation Criteria in Solid Tumors (RECIST).
* WHO performance status 0 - 2
* Able to provide written informed consent

Exclusion Criteria

* Clinical findings associated with an unacceptably high tumor biopsy risk, according to the judgement of the investigator.
* Radiotherapy on target lesions during study or within 4 weeks of the start of drug.
* Any condition that is unstable or could jeopardize the safety of the subject and their compliance in the study.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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M. Labots

OTHER

Sponsor Role lead

Responsible Party

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M. Labots

Medical Oncologist

Responsibility Role SPONSOR_INVESTIGATOR

Locations

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VU Medical Center

Amsterdam, North Holland, Netherlands

Site Status

Countries

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Netherlands

Other Identifiers

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2012/109

Identifier Type: -

Identifier Source: org_study_id