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

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We do not endorse or review these studies in any way.

Trial Identification

Brief 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

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

Study ID: NCT01995981

Interventions

Pazopanib

Study Description

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 Description:

Eligibility

Minimum Age: 18 Years

Eligible Ages: ADULT, OLDER_ADULT

Sex: ALL

Healthy Volunteers: No

Locations

Radboud University Nijmegen Medical Centre, Nijmegen, , Netherlands

Royal Marsden Hospital, London, , United Kingdom

Contact Details

Name: Winette van der Graaf, prof. PhD. MD

Affiliation: Radboud University Medical Center

Role: PRINCIPAL_INVESTIGATOR

Name: Wim Oyen, prof. PhD. MD

Affiliation: Radboud University Medical Center

Role: PRINCIPAL_INVESTIGATOR

Name: Nielka van Erp, PharmD. PhD.

Affiliation: Radboud University Medical Center

Role: PRINCIPAL_INVESTIGATOR

Useful links and downloads for this trial

Clinicaltrials.gov

Google Search Results

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