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Individualizing Pazopanib Therapy by exploRing the Role of Early Metabolic responsE and Drug Exposure as a preDICTor for Treatment Outcome in Patients With STS

NCT01995981 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 22

Last updated 2017-12-19

No results posted yet for this study

Summary

This study is a phase IV post registration prospective observational feasibility study in patients with metastatic soft tissue sarcoma. Pazopanib is the registered treatment for patients with advanced soft tissue sarcoma after chemotherapy with doxorubicin or ifosfamide.

* This study looks at the possibility of using 18F-2-fluoro-2-deoxy-D-glucose fluorodeoxyglucose (FDG) positron emission tomography PET scans as an early biomarker of pazopanib treatment effect in patients.
* It also studies pazopanib pharmacokinetics to see if there are differences between elderly and younger patients.

The primary objectives are:

* To evaluate whether early metabolic response is correlated to clinical benefit.
* To evaluate the effect of age (≥ 70 years) on pazopanib pharmacokinetics.

The secondary objectives are:

* To evaluate whether early metabolic response (% decrease in FDG uptake due to pazopanib therapy) is correlated with pazopanib exposure.
* To evaluate whether early metabolic response (% decrease in FDG uptake due to pazopanib therapy) is correlated with the histological subtypes.

Conditions

  • Sarcoma, Soft Tissue

Interventions

DRUG

Pazopanib

Sponsors & Collaborators

  • GlaxoSmithKline

    collaborator INDUSTRY

  • Radboud University Medical Center

    lead OTHER

Principal Investigators

  • Winette van der Graaf, prof. PhD. MD · Radboud University Medical Center

  • Wim Oyen, prof. PhD. MD · Radboud University Medical Center

  • Nielka van Erp, PharmD. PhD. · Radboud University Medical Center

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-12-31
Primary Completion
2017-11-10
Completion
2017-11-10

Countries

  • Netherlands
  • United Kingdom

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 NCT01995981 on ClinicalTrials.gov