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.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
148
oral tablet
GSK Investigational Site
Brussels, Belgium
GSK Investigational Site
Leuven, Belgium
GSK Investigational Site
Lyon, France
Progression Free Survival at Week 12
Progression free survival at week 12 is the number of participants who had a complete response (CR, all detectable tumor had disappeared) or a partial response (PR, a \>=30% decrease in the sum of the longest dimensions of the target lesions taking as a reference the baseline sum) or stable disease (SD, no change) 12 weeks from start of therapy, per response evaluation criteria in solid tumors (RECIST v1.0). Clinical progression is progression of disease without documented radiological evidence. Progressive disease (PD), a \>=20% increase in target lesions.
Time frame: Week 12
Overall Survival
Overall survival is defined as the time from start of therapy until death. Participants who were still alive at the time of analysis were censored.
Time frame: Start of therapy until death (up to approximately 5 years)
Progression Free Survival
Progression free survival is defined as the interval between the start of treatment and the earliest date of disease progression or death due to any cause. Assessments of progression were made by the investigator.
Time frame: Start of therapy until progression (up to approximately 5 years)
Overall Response
Overall response is the number of participants who had a best outcome of a complete response (CR, all detectable tumor had disappeared) or a partial response (PR, a \>=30% decrease in the sum of the longest dimensions of the target lesions taking as a reference the baseline sum) per response evaluation criteria in solid tumors (RECIST v1.0) at some point during the study. Progressive disease (PD), a \>=20% increase in target lesions. Clinical progression is progression of disease without documented radiological evidence.
Time frame: Baseline until either response or progression (up to approximately 5 years)
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
GSK Investigational Site
Marseille, France
GSK Investigational Site
Paris, France
GSK Investigational Site
Villejuif, France
GSK Investigational Site
Budapest, Hungary
GSK Investigational Site
Groningen, Netherlands
GSK Investigational Site
Leiden, Netherlands
GSK Investigational Site
Rotterdam, Netherlands
...and 6 more locations