Phase II clinical study of concurrent PAzopanib for non-metastatic SArcoma patients to be treated with RadioTherapy, localized in the extremities, trunk and chest wall or the head and neck region - PASART-2

The Netherlands Cancer Institute0 个研究点目标入组 35 人开始时间: 2015年10月20日最近更新: 2016年1月11日

适应症

试验速览

暂无简介。

•Histologically confirmed newly diagnosed intermediate to high grade soft tissue sarcoma localized to the extremities, trunk and chest wall or the head and neck area, for which the standard treatment is a combination of radiotherapy and surgery (deep seated, > 5cm according to the RECIST 1.1 criteria and/or an anticipated close resection margin, grade II/III according to the WHO definition)
•Age = 18 years
•WHO performance status of = 1
•Able and willing to undergo blood sampling for PK and PD analysis
•Able to swallow and retain oral medication
•Able and willing to undergo MRI scanning
•Able and willing to undergo tumor biopsies
•Adequate organ functions as described by the laboratory findings in table 1. For thyroid function, the T4 and TSH values must be within normal values of the range of the participating centers
•Written informed consent
•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 30
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 5

•Prior malignancies; except another malignancy and disease-free for = 5 years, or completely resected non-melanomatous skin carcinoma or successfully treated in situ carcinoma
•Patients with recurrent sarcomas (even without prior radiotherapy)
•Ewing sarcoma and other PNET family tumors, rhabdomyosarcomas (both pediatric and adult), osteosarcomas
•Clinically significant gastrointestinal abnormalities which might interfere with oral dosing diagnosed
•Poorly controlled hypertension [defined as systolic blood pressure (SBP) of = 140 mmHg or diastolic blood pressure (DBP) of = 90mmHg]
•Unstable or serious concurrent condition (e.g., active infection requiring systemic therapy)
•Prolongation of corrected QT interval (QTc) > 480 msecs on ECG
•History of any one of more cardiovascular conditions within the past 6 months
•Macroscopic hematuria
•Hemoptysis that is clinically relevant within 4 weeks of first pazopanib
•Evidence of active bleeding or bleeding diathesis
•Prior major surgery or trauma within 28 days prior to first dose of study medication
•Female patients who are pregnant, breast-feeding or male or female patients of reproductive potential who are not employing an effective method of birth

发起方