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Clinical Evaluation of the Underlying Mechanisms of Targeted Therapy Related Toxicities

NCT01758575 · Status: TERMINATED · Type: OBSERVATIONAL · Enrollment: 8

Last updated 2017-04-07

No results posted yet for this study

Summary

Single center, non-randomized, interventional pilot study with feasibility analysis after enrollment of 20 patients. Adult patients with advanced solid tumors, for whom standard palliative treatment with targeted agents as monotherapy is indicated, including antiangiogenic tyrosine kinase inhibitors, EGFR inhibitors, mTOR inhibitors, BRAF inhibitors and ipilimumab.After feasibility analysis in the first twenty patients, twenty more patients will be included in each of the five drug cohorts. Biopsies will be performed to determine possible immunohistochemical and histopathological changes in normal tissue, possible immunomodulatory changes as expressed by Tcell phenotyping and cytokine profiling and to compare tissue (phospho) proteomic and kinase activity profiles before and during therapy and also at the development of toxicity.The main objective of this pilot study is to determine the biological impact of treatment with targeted agents at the systemic and local tissue level in relation to toxicity.

Conditions

  • Advanced or Metastatic Solid Malignancy

Sponsors & Collaborators

  • Amsterdam UMC, location VUmc

    lead OTHER

Principal Investigators

  • Henk MW Verheul, MD, PhD · Amsterdam UMC, location VUmc

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-11-30
Primary Completion
2017-04-30
Completion
2017-04-30

Countries

  • Netherlands

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01758575 on ClinicalTrials.gov