Individualizing Pazopanib therapy by exploRing the role of Early metabolic responsE and drug exposure as a preDICTor for treatment outcome in patients with STS

Phase 4

Recruiting

Conditions: Soft tissue sarcom
10072990

Registration Number: NL-OMON41252

Lead Sponsor: Medische Oncologie

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Recruiting

Sex: Not specified

Target Recruitment: 30

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

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

Study & Design

Study Type: Observational invasive

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>- The aim of this study is to show distinction between the PFS curves between<br /><br>the patients who have a more or less pronounced metabolic response.<br /><br>- The aim of this study is to show a difference in pazopanib exposure<br /><br>(AUC0-24hr) between elderly (>= 70 years) compared to younger (<= 65 years)<br /><br>patients. The difference in exposure should at least be 15% to consider<br /><br>expansion of the study to a larger cohort.</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>- To explore, quantify and describe the correlation between early metabolic<br /><br>response and pazopanib exposure (AUC) on steady-state pharmacokinetics<br /><br>- To explore, quantify and describe the correlation between tumor histology and<br /><br>early metabolic response<br /><br>- To explore, quantify and describe the correlation between pazopanib exposure<br /><br>and the frequency of adverse events as graded by CTCAE v4.0</p><br>