Text Size

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

This study is currently recruiting participants.
Verified December 2012 by VU University Medical Center
Sponsor:
Information provided by (Responsible Party):
H.M.W. Verheul, VU University Medical Center
ClinicalTrials.gov Identifier:
NCT01636908
First received: July 5, 2012
Last updated: December 11, 2012
Last verified: December 2012
History of Changes
  Purpose

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


Condition Intervention
Cancer
Advanced Solid Tumors
 Drug: Sunitinib
Drug: Sorafenib
Drug: Erlotinib
Drug: Everolimus
Drug: Lapatinib
Drug: Dasatinib
Drug: Pazopanib
Drug: Vemurafenib
Procedure: tumor biopsy
Procedure: skin biopsy (optional)

Study Type: Interventional
Study Design: Endpoint Classification: Pharmacokinetics/Dynamics Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Official Title: Pilot Study on the Determination of Intratumoral Concentrations of Kinase Inhibitors in Patients With Advanced Solid Malignancies.

Resource links provided by NLM:

MedlinePlus related topics: Cancer
U.S. FDA Resources

Further study details as provided by VU University Medical Center:

Primary Outcome Measures:
  • concentrations of intratumoral kinase inhibitors upon 2 weeks of treatment [ Time Frame: 2 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • kinase inhibitor concentrations in plasma, serum and PBMC's upon 2 weeks of treatment [ Time Frame: 2 weeks ] [ Designated as safety issue: No ]
  • intra-dermal kinase inhibitor concentrations upon 2 weeks of treatment [ Time Frame: 2 weeks ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]

Estimated Enrollment: 40
Study Start Date: August 2011
Estimated Primary Completion Date: August 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Kinase inhibitor
Patients are cohort-wise treated with a registered (tyrosine) kinase inhibitor
 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)

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01636908

Locations
Netherlands
VUMedical Center Recruiting
Amsterdam, Netherlands, 1081 HV
Contact: H.M.W. Verheul, MD, PhD     0031-20-4444321     h.verheul@vumc.nl    
Principal Investigator: H.M.W. Verheul, MD, PhD            
Sponsors and Collaborators
VU University Medical Center
Investigators
Principal Investigator: H.M.W. Verheul, MD, PhD VU Medical Center Amsterdam
  More Information

No publications provided

Responsible Party: H.M.W. Verheul, Head Department Medical Oncology, VU University Medical Center
ClinicalTrials.gov Identifier: NCT01636908     History of Changes
Other Study ID Numbers: 2011/128
Study First Received: July 5, 2012
Last Updated: December 11, 2012
Health Authority: Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)

Additional relevant MeSH terms:
Everolimus
Sirolimus
Sorafenib
Sunitinib
Lapatinib
Erlotinib
Dasatinib
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions
Antibiotics, Antineoplastic
 Antineoplastic Agents
Therapeutic Uses
Antifungal Agents
Anti-Infective Agents
Anti-Bacterial Agents
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Growth Inhibitors

ClinicalTrials.gov processed this record on June 17, 2013