Sarcoma, Soft Tissue Clinical Trial
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
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.
n/a
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