Prediction of response to kinase inhibitors based on protein phosphorylation profiles in tumor tissue from advanced renal cell cancer patients

• Conditions: Advanced solid tumors; Therapeutic area: Diseases [C] - Cancer [C04]

• Registration Number: EUCTR2011-006009-85-NL
• Lead Sponsor: VU University medical center

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2012-05-09
• Last Update Posted: 26 June 2012

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 225

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

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 180
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 45

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 study drug.
•Any condition that is unstable or could jeopardize the safety of the subject and their compliance in the study.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified