Pazopanib In Patients With Relapsed Or Refractory Soft Tissue Sarcoma (NCT00297258) | Clinical Trial Compass
CompletedPhase 2
Pazopanib In Patients With Relapsed Or Refractory Soft Tissue Sarcoma
Belgium, France148 participantsStarted 2005-11
Plain-language summary
The purpose of this study is to evaluate the activity and tolerability of pazopanib in subjects with advanced and/or metastatic soft tissue sarcoma who have relapsed following standard therapies or for whom no standard therapy exists and to characterize the pharmacokinetics of pazopanib in this subject population.
Who can participate
Age range21 Years
SexALL
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Inclusion Criteria:
* Histological evidence of high or intermediate grade malignant soft tissue sarcoma, or cytological evidence in case of presence of multiple metastases. List of eligible and ineligible tumours are included in the protocol.
* Formalin fixed paraffin embedded tumour blocks and representative H/E (haematoxylin/eosin) slides must be available for histological central review. Histological central review is not required before treatment start but is mandatory within 3 months of registration. Local histopathological diagnosis will be accepted for entry into the study.
* Presence of measurable disease (according to RECIST criteria).
* Relapsed or refractory disease incurable by surgery or radiotherapy.
* Evidence of objective progression within the last 6 months (RECIST) documented by measurements of disease,
* Patients must either not be eligible for chemotherapy (for instance because of age, or because of a biological condition, or because of patient-refusal) or must have received no more than one combination or two single agents chemotherapy regimen for advanced disease; (neo) adjuvant therapy is not counted towards this requirement.
* At least 18 years of age
* WHO performance status 0 or 1
* Adequate bone marrow function
* Adequate hepatic function
* Adequate renal function
* PT / PTT less than 1.2 x UNL.
* LVEF above the lower limit of normal for the institution, based on ECHO or MUGA
* Able to swallow and retain oral medication
* Women should not be of chi…