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

Radboud University Nijmegen Medical Centre0 个研究点目标入组 30 人开始时间: 2013年9月24日最近更新: 2018年1月29日

适应症

试验速览

暂无简介。

•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. Patients aged 66-69 are eligible for the imaging arm of the study, however they are excluded from the assessment of altered PK behavior in elderly.
•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.
•Are the trial subjects under 18? no
•Number of subjects for this age range:
•F.1.2 Adults (18-64 years) yes
•F.1.2.1 Number of subjects for this age range 20
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 10

•1) Prior malignancy.
•2) Central nervous system (CNS) metastases at baseline, with the exception of those subjects who have previously-treated CNS metastases (surgery ± radiotherapy, radiosurgery, or gamma knife) and who meet both of the following criteria: a) are asymptomatic and b) have no requirement for steroids or enzyme-inducing anticonvulsants in prior 6 months time interval
•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
•6) History of one or more cardiovascular conditions within the past 6 months as unstable angina, myocardial infarction, etc.
•7) Poorly controlled hypertension
•8) History of cerebrovascular accident including transient ischemic attack (TIA), pulmonary embolism or untreated deep venous thrombosis (DVT) within the past 6 months.
•9) Major surgery or trauma within 28 days prior to first dose of investigational product and/or presence of any non-healing wound, fracture, or ulcer (procedures such as catheter placement not considered to be major surgery).
•10) Evidence of active bleeding or bleeding diathesis

发起方

Radboud University Nijmegen Medical Centre