Determination of Intratumoral Concentrations of Kinase Inhibitors in Patients With Advanced Solid Malignancies. (ICK)

Amsterdam UMC, location VUmc

Status: Completed

Conditions: Advanced Solid Tumors; Cancer

Treatments: Drug: Pazopanib; Drug: Lapatinib; Drug: Everolimus; Procedure: tumor biopsy; Drug: Sunitinib; Drug: Sorafenib; Drug: Dasatinib; Drug: Erlotinib; Drug: Vemurafenib; Procedure: skin biopsy (optional)

Study type: Interventional

Funder types: Other

Identifiers

NCT01636908

2011/128

Details and patient eligibility

About

The purpose of this study is to determine intratumoral concentration of kinase inhibitors upon 2 weeks of treatment in tumor tissue of patients.

Full description

Patients will be cohort-wise treated with clinically available kinase inhibitors for 2 weeks prior to standard palliative treatment. Five patients will be included in each of eight drug cohorts. Biopsies will be performed to determine intratumoral drug concentrations and to compare tissue (phospho)proteomic and kinase activity profiles before and during therapy.

Enrollment: 43 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Advanced solid malignancy
• minimum age 18 years
• indication for palliative treatment
• measurable disease with at least one lesion accessable for biopsy

Exclusion criteria

• Cardiovascular conditions including congestive heartfailure NYHA class >2
• recent myocardial infarction or uncontrolled coronary artery disease
• cardiac arrhythmias requiring anti-arrhythmic therapy
• uncontrolled hypertension
• uncontrolled infections
• serious non-healing wound, ulcer or bone fracture
• pregnant or breast feeding

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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43 participants in 1 patient group

Kinase inhibitor

Experimental group

Description:

Patients are cohort-wise treated with a registered (tyrosine) kinase inhibitor

Treatment:

Drug: Everolimus

Drug: Sunitinib

Procedure: tumor biopsy

Drug: Pazopanib

Drug: Lapatinib

Drug: Dasatinib

Drug: Sorafenib

Drug: Erlotinib

Drug: Vemurafenib

Procedure: skin biopsy (optional)