Advanced solid tumors
Conditions
Interventions
Trade Name: Sutent
Product Name: sunitinib
Product Code: L01XE04
Pharmaceutical Form: Capsule, hard
INN or Proposed INN: SUNITINIB
CAS Number: 557795-19-4
Current Sponsor code: Sunitinib
Concentration
Sponsors
VU University medical center
Eligibility
Sex/Gender
All
Inclusion criteria
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
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To determine the relation between tumor tissue phosphoproteomic profiles and progression-free survival (PFS) in patients with advanced renal cell cancer;Secondary Objective: - To determine the relation between pre-treatment PamChip kinase activity profiling and PFS - To determine whether genome-wide mutational profiles by Massively Parallel Sequencing (MPS) can be related to PFS - To determine whether both pre- and on-treatment serum proteomic profiles are related to PFS - To determine the value of the frequency and phenotype of immunoregulatory cells in blood and tumor tissue for treatment response prediction. - To determine the relation between genetic polymorphisms and pharmacokinetic parameters (systemic and intratumoral drug concentrations) and PFS. - To determine the value of tumor exosomes from urine and serum as potential source of biomarkers. ;Primary end point(s): Prediction accuracy of the phosphoproteomic classifier;Timepoint(s) of evaluation of this end point: End of study | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Prediction accuracy of classifiers based on following parameters: - serum peptidomics profile - proteomic profile of tumor derived exosomes ;Timepoint(s) of evaluation of this end point: End of study | — |
Countries
Netherlands, United States
Contacts
Public ContactDepartment of Medical Oncology
VU University medical center
Outcome results
None listed