Individualizing Pazopanib Therapy by exploRing the Role of Early Metabolic responsE and Drug Exposure as a preDICTor for Treatment Outcome in Patients With STS (PREDICT)
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|ClinicalTrials.gov Identifier: NCT01995981|
Recruitment Status : Completed
First Posted : November 27, 2013
Last Update Posted : December 19, 2017
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.
|Condition or disease||Intervention/treatment|
|Sarcoma, Soft Tissue||Drug: Pazopanib|
|Study Type :||Observational|
|Actual Enrollment :||22 participants|
|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|
|Actual Study Start Date :||December 2013|
|Actual Primary Completion Date :||November 10, 2017|
|Actual Study Completion Date :||November 10, 2017|
Advanced soft tissue sarcoma patients
Advanced soft tissue sarcoma patients, who have an indication for pazopanib treatment.
Other Name: Votrient
- 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
- Adverse events (CTCAE v4.0) [ Time Frame: 2 weeks and 8 weeks after start treatment ]
Biospecimen Retention: Samples With DNA
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01995981
|Radboud University Nijmegen Medical Centre|
|Nijmegen, Netherlands, 6525 GA|
|Royal Marsden Hospital|
|London, United Kingdom|
|Principal Investigator:||Winette van der Graaf, prof. PhD. MD||Radboud University|
|Principal Investigator:||Wim Oyen, prof. PhD. MD||Radboud University|
|Principal Investigator:||Nielka van Erp, PharmD. PhD.||Radboud University|