NCT01636908

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

Pilot Study on the Determination of Intratumoral Concentrations of Kinase Inhibitors in Patients With Advanced Solid Malignancies.

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 43 (actual)
• Sponsor: Amsterdam UMC, location VUmc · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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

Detailed 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.

Conditions

• Cancer
• Advanced Solid Tumors

Interventions

Type	Name	Description
DRUG	Sunitinib	50 mg once daily, oral use, 14 days
DRUG	Sorafenib	400 mg, twice daily, oral use, 14 days
DRUG	Erlotinib	150 mg once daily, oral use, 14 days
DRUG	Everolimus	10 mg once daily, oral use, 14 days
DRUG	Lapatinib	1250 mg once daily, oral use, 14 days
DRUG	Dasatinib	100 mg once daily, oral use, 14 days
DRUG	Pazopanib	800 mg once daily, oral use, 14 days
DRUG	Vemurafenib	960 mg twice daily, oral use, 15-21 days
PROCEDURE	tumor biopsy
PROCEDURE	skin biopsy (optional)

Timeline

• Start date: 2011-08-01
• Primary completion: 2018-01-01
• Completion: 2019-12-01
• First posted: 2012-07-10
• Last updated: 2021-04-15

Locations

1 site across 1 country: Netherlands