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Completed

NCT Number: NCT01636908

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

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

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Key information

Conditions

Cancer Advanced Solid Tumors Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

VUMedical Center

Amsterdam, 1081 HV, Netherlands

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Sunitinib

Drug

50 mg once daily, oral use, 14 days

Sorafenib

Drug

400 mg, twice daily, oral use, 14 days

Erlotinib

Drug

150 mg once daily, oral use, 14 days

Everolimus

Drug

10 mg once daily, oral use, 14 days

Lapatinib

Drug

1250 mg once daily, oral use, 14 days

dasatinib

Drug

100 mg once daily, oral use, 14 days

Pazopanib

Drug

800 mg once daily, oral use, 14 days

Vemurafenib

Drug

960 mg twice daily, oral use, 15-21 days

Tumor Biopsy

Procedure

skin biopsy (optional)

Procedure

Primary outcomes

  1. concentrations of intratumoral kinase inhibitors upon 2 weeks of treatment

    Time frame: 2 weeks

Secondary outcomes

  1. kinase inhibitor concentrations in plasma, serum and PBMC's upon 2 weeks of treatment

    Time frame: 2 weeks

  2. intra-dermal kinase inhibitor concentrations upon 2 weeks of treatment

    Time frame: 2 weeks

  3. To determine per patient whether 2 weeks of treatment with kinase inhibitors induces significant change of phosphoproteomic profiles in tumor tissue

    Time frame: 2 weeks

  4. To determine per patient whether 2 weeks of treatment with kinase inhibitors induces significant change of kinase activity in tumor tissue

    Time frame: 2 weeks

Sponsors and collaborators

Lead sponsor

Amsterdam UMC, location VUmc

Other

Registry information

Official study title

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

Acronym: ICK

Important dates

Study start
2011
Primary completion
2018
Study completion
2019
First posted
Jul 10, 2012
Registry last updated
Apr 15, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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