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Biomarker Development for Response Prediction by DNA Mutational Analysis

NCT01855061 · Status: TERMINATED · Type: OBSERVATIONAL · Enrollment: 79

Last updated 2018-03-09

No results posted yet for this study

Summary

The purpose of this study is to determine whether it is possible to predict response to chemotherapy in patients with metastatic cancer who are treated with irinotecan by determining the mutational profile of the tumor.

Conditions

  • Neoplasm Metastasis

Interventions

PROCEDURE

Biopsy

Histological biopsy of the "index lesion" (a radiological measurable lesion on which biopsy is performed) at baseline, as well as when showing progressive disease. Histological biopsies will be subjected to DNA sequencing to assess the mutational profile, as well as to analysis of carboxylesterase activity.

PROCEDURE

Blood samples

Blood samples will be taken at baseline to determine patient's genetic background variation (germline DNA).

PROCEDURE

Pharmacokinetics

Blood samples will be taken for pharmacokinetic analysis of the active irinotecan metabolite (SN-38).

PROCEDURE

Midazolam clearance test

Patients who are being treated in Rotterdam will be subjected to blood draws for validation of the earlier developed midazolam phenotyping test (midazolam clearance test), which may be an indicator for pharmacokinetics of irinotecan.

Sponsors & Collaborators

  • Erasmus Medical Center

    collaborator OTHER

  • The Netherlands Cancer Institute

    collaborator OTHER

  • P.O. Witteveen

    lead OTHER

Principal Investigators

  • Marlies Langenberg, MD/PhD · UMC Utrecht

  • Neeltje Steeghs, MD/PhD · Netherlands Cancer Institute - Antoni van Leeuwenhoek hospital, Amsterdam

  • Ron Mathijssen, MD/PhD · Erasmus Medical Center - Daniël den Hoed clinic, Rotterdam

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-05-31
Primary Completion
2015-11-30
Completion
2016-08-31

Countries

  • Netherlands

Study Locations

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Entities

Companies

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 NCT01855061 on ClinicalTrials.gov