Soft tissue sarcom
Conditions
Interventions
None listed
Sponsors
Medische Oncologie
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: 1) Subjects must provide written informed consent prior to performance of study-specific procedures or assessments and must be willing to comply with treatment and follow up. 2) Age >= 18 years or legal age of consent if greater than 18 years. 3) Histological confirmed diagnosis of selective subtypes of advanced soft tissue sarcoma (STS) who have received prior chemotherapy for metastatic disease or who have progressed within 12 months after (neo) adjuvant therapy. 4) Eastern Cooperative Oncology Group (ECOG) performance status of 0-2. 5) Measurable disease criteria (RECIST 1.1). 6) No radio-, chemo- or tumor specific targeted therapy within the last 4 weeks prior to study entry. 7) Adequate organ system function. 8) Minimal evaluable laesion of >= 15mm.
Exclusion criteria
Exclusion criteria: 1) Prior malignancy. 2) Central nervous system (CNS) metastases at baseline 3) Clinically significant gastrointestinal abnormalities that may increase the risk for gastrointestinal bleeding 4) Clinically significant gastrointestinal abnormalities that may affect absorption of investigational product 5) Corrected QT interval (QTc) > 480msecs
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| - The aim of this study is to show distinction between the PFS curves between the patients who have a more or less pronounced metabolic response. - The aim of this study is to show a difference in pazopanib exposure (AUC0-24hr) between elderly (>= 70 years) compared to younger ( | — |
Secondary
| Measure | Time frame |
|---|---|
| - To explore, quantify and describe the correlation between early metabolic response and pazopanib exposure (AUC) on steady-state pharmacokinetics - To explore, quantify and describe the correlation between tumor histology and early metabolic response - To explore, quantify and describe the correlation between pazopanib exposure and the frequency of adverse events as graded by CTCAE v4.0 | — |
Countries
Netherlands
Outcome results
None listed