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

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Observational

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

Brief 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.

Detailed Summary:
Sponsor: Radboud University

Current Primary Outcome:

  • FDG (18F-2-fluoro-2-deoxy-D-glucose fluorodeoxyglucose) uptake [ Time Frame: baseline, 2 weeks and 8 weeks after start treatment ]
  • Pharmacokinetics (AUC) [ Time Frame: 0, 1, 2, 3, 4, 6, 8, 10, 24 hours post-dose ]
    This measurement is performed at 2 weeks and 8 weeks after start treatment


Original Primary Outcome:

  • FDG (18F-2-fluoro-2-deoxy-D-glucose fluorodeoxyglucose) uptake [ Time Frame: baseline, 2 weeks and 8 weeks after start treatment ]
  • Pharmacokinetics (AUC) [ Time Frame: 0, 1, 2, 3, 4, 6, 8, 10, 24 hours post-dose ]
    This measurement is performed at 2 weeks and 8 weeks after start treatmentdone


Current Secondary Outcome: Adverse events (CTCAE v4.0) [ Time Frame: 2 weeks and 8 weeks after start treatment ]

Original Secondary Outcome: Same as current

Information By: Radboud University

Dates:
Date Received: November 21, 2013
Date Started: December 2013
Date Completion:
Last Updated: June 23, 2015
Last Verified: June 2015