A randomised double blind phase 2 trial of whole brain radiotherapy with or without vandetanib in metastatic melanoma with brain metastases

Oxford University (UK)0 个研究点目标入组 86 人开始时间: 2011年8月17日最近更新: 2022年4月4日

适应症

试验速览

•1. More than or equal to 18 years of age, written informed consent
•2. Histological confirmation of malignant melanoma
•3. Unresectable Stage III or IV metastatic melanoma with brain metastases
•4. Karnofsky Performance Score > 70%
•5. Radiation Therapy Oncology Group recursive partitioning analysis (RTOG RPA) score 1 or 2
•6. Measurable disease as defined by RECIST version 1.1
•7. Adequate haematological, hepatic and renal function
•8. Adequate cardiac function New York Heart Association (NHYA) 0-1
•9. QTc < 480msec
•Target Gender: Male & Female ; Lower Age Limit 18 years

•1. Radiotherapy or systemic melanoma therapy within 28 days prior to starting treatment
•2. Prior whole brain irradiation
•3. Central nervous system (CNS) melanoma where all detectable disease has been treated by neurosurgery or stereotactic irradiation
•4. Presence of leptomeningeal disease
•5. More than 3 extra-cranial organ sites involved with melanoma
•6. Pregnancy or breastfeeding women
•7. Significant cardiovascular disease
•8. Uncontrolled hypertension
•9. Serum calcium, magnesium or potassium below the normal range despite supplementation
•10. Requirement for medication that increases QTc and/or the risk of torsades de point
•11. Requirement for medication that is a potent inducer of CYP3A4 function
•12. Ocular malignant melanoma
•13. Another active malignancy within the past five years
•14. Clinically significant and uncontrolled major medical condition(s)
•15. Any condition that would preclude adequate absorption of vandetanib

发起方

Oxford University (UK)