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

Cancer Clinical Trial

— ICK  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01636908
• Other study ID #: 2011/128
• Status: Completed
• Phase: N/A
• Start date: August 2011
• Est. completion date: December 1, 2019

Study information

• Verified date: April 2021
• Source: VU University Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 43
• Est. completion date: December 1, 2019
• Est. primary completion date: January 1, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Advanced Solid Tumors
• Cancer
• Neoplasms

Intervention

Drug:
• Sunitinib
50 mg once daily, oral use, 14 days
• Sorafenib
400 mg, twice daily, oral use, 14 days
• Erlotinib
150 mg once daily, oral use, 14 days
• Everolimus
10 mg once daily, oral use, 14 days
• Lapatinib
1250 mg once daily, oral use, 14 days
• Dasatinib
100 mg once daily, oral use, 14 days
• Pazopanib
800 mg once daily, oral use, 14 days
• Vemurafenib
960 mg twice daily, oral use, 15-21 days

Procedure:
• tumor biopsy

• skin biopsy (optional)

Locations

Country	Name	City	State
Netherlands	VUMedical Center	Amsterdam

Sponsors (1)

Lead Sponsor	Collaborator
VU University Medical Center

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	concentrations of intratumoral kinase inhibitors upon 2 weeks of treatment		2 weeks
Secondary	kinase inhibitor concentrations in plasma, serum and PBMC's upon 2 weeks of treatment		2 weeks
Secondary	intra-dermal kinase inhibitor concentrations upon 2 weeks of treatment		2 weeks
Secondary	To determine per patient whether 2 weeks of treatment with kinase inhibitors induces significant change of phosphoproteomic profiles in tumor tissue		2 weeks
Secondary	To determine per patient whether 2 weeks of treatment with kinase inhibitors induces significant change of kinase activity in tumor tissue		2 weeks