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

NCT ID: NCT01636908

Last Updated: 2021-04-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

43 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-08-31

Study Completion Date

2019-12-01

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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

See the medical conditions and disease areas that this research is targeting or investigating.

Cancer Advanced Solid Tumors

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Kinase inhibitor

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

Group Type EXPERIMENTAL

Sunitinib

Intervention Type DRUG

50 mg once daily, oral use, 14 days

Sorafenib

Intervention Type DRUG

400 mg, twice daily, oral use, 14 days

Erlotinib

Intervention Type DRUG

150 mg once daily, oral use, 14 days

Everolimus

Intervention Type DRUG

10 mg once daily, oral use, 14 days

Lapatinib

Intervention Type DRUG

1250 mg once daily, oral use, 14 days

Dasatinib

Intervention Type DRUG

100 mg once daily, oral use, 14 days

Pazopanib

Intervention Type DRUG

800 mg once daily, oral use, 14 days

Vemurafenib

Intervention Type DRUG

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

tumor biopsy

Intervention Type PROCEDURE

skin biopsy (optional)

Intervention Type PROCEDURE

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Sunitinib

50 mg once daily, oral use, 14 days

Intervention Type DRUG

Sorafenib

400 mg, twice daily, oral use, 14 days

Intervention Type DRUG

Erlotinib

150 mg once daily, oral use, 14 days

Intervention Type DRUG

Everolimus

10 mg once daily, oral use, 14 days

Intervention Type DRUG

Lapatinib

1250 mg once daily, oral use, 14 days

Intervention Type DRUG

Dasatinib

100 mg once daily, oral use, 14 days

Intervention Type DRUG

Pazopanib

800 mg once daily, oral use, 14 days

Intervention Type DRUG

Vemurafenib

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

Intervention Type DRUG

tumor biopsy

Intervention Type PROCEDURE

skin biopsy (optional)

Intervention Type PROCEDURE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Amsterdam UMC, location VUmc

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

M. Labots

Medical Oncologist

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

H.M.W. Verheul, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

VU Medical Center Amsterdam

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

VUMedical Center

Amsterdam, , Netherlands

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Netherlands

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

2011/128

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

A Study of ADRX-0706 in Select Advanced Solid Tumors
NCT06036121 ACTIVE_NOT_RECRUITING PHASE1
Phase 1 Safety Testing of SAR405838
NCT01636479 COMPLETED PHASE1