NCT01995981

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

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 22 (actual)
• Sponsor: Radboud University Medical Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Type	Name	Description
DRUG	Pazopanib

Timeline

• Start date: 2013-12-01
• Primary completion: 2017-11-10
• Completion: 2017-11-10
• First posted: 2013-11-27
• Last updated: 2017-12-19

Locations

2 sites across 2 countries: Netherlands, United Kingdom