EUCTR2016-001797-15-NL进行中（未招募）1 期
A phase II/III study of high-dose, intermittent sunitinib in patients with recurrent glioblastoma multiforme - Phase II/III study of high-dose, intermittent sunitinib in recurrent GBM
VU University Medical Center, Department of Medical Oncology0 个研究点目标入组 100 人开始时间: 2016年7月7日最近更新:
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 100
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •In order to be eligible to participate in this study, a subject must meet all of the following criteria:
- •1. Signed (by the patient or legally acceptable representative) and dated Informed Consent Form
- •2. Histologically confirmed de novo or secondary glioblastoma with unequivocal first progression, at least 3 months off radiotherapy.
- •3. No more than one line of chemotherapy (concurrent and adjuvant temozolomide based chemotherapy including in combination with another investigational agent is considered one line of chemotherapy). Chemotherapy must have been completed at least 4 weeks prior to randomization.
- •4. Patients may have undergone surgery for recurrence. If operated, residual and measurable disease after surgery is not required but surgery must have confirmed the recurrence.
- •5. No radiotherapy, stereotactic radiosurgery or brachytherapy as treatment for recurrence.
- •6. Patients must have a Karnofsky Performance Score = 70%
- •7. Patients need to have adequate hematological, renal and hepatic function as assessed by the following laboratory requirements to be conducted within seven days prior to start study treatment:
- •7a. Hemoglobin = 7.0 mmol/L
- •7b. Absolute neutrophil count (ANC) = 1.5 x 109/L
- •7c. Platelet count = 100 x 109/L
- •7d. ALAT and ASAT = 2.5 x ULN
- •7e. Serum creatinine eGFR = 50 ml/min
- •7f. Albumin = 25 g/L
- •8. Age = 18 years
- •9. Male and female patients with reproductive potential must use an approved contraceptive method during and for three months after discontinuation of study treatment.
- •10. Patients must be able to swallow oral medication.
- •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 75
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 25
排除标准
- •A potential subject who meets any of the following criteria will be excluded from participation in this study:
- •1. Evidence of a significant uncontrolled concomitant disease, such as cardiovascular disease (including stroke, New York Heart Association Class III or IV cardiac disease or myocardial infarction within 6 months prior to screening, unstable arrhythmia, clinically significant valvular heart disease and unstable angina); nervous system, pulmonary (including obstructive pulmonary disease and history of symptomatic bronchospasm), renal, hepatic, endocrine, or gastrointestinal disorders; or a serious non-healing wound or fracture.
- •2. Patients with a prior (< 5 years) or concomitant second malignancy.
- •3. Prior radiotherapy in the abdomen or in the lungs or in more than 3 vertebrae in the spine (Less than 3 vertebrae are considered a small radiation field and eligibility will be decided on an individual basis from the PI)
- •4. Poorly controlled hypertension despite adequate blood pressure medication. Blood pressure must be = 160/95 mmHg at the time of screening on a stable antihypertensive regimen. Blood pressure must be stable on at least 2 separate measurements.
- •5. Known active bacterial, viral, fungal, mycobacterial, or other infection (including HIV and atypical mycobacterial disease, but excluding fungal infection of the nail beds.)
- •6. Initial MR-scan of the brain showing intratumoral hemorrhage, except for stable post-operative grade 1 hemorrhage.
- •7. Known hypersensitivity to sunitinib or to its excipients.
- •8. Presence of any significant central nervous system or psychiatric disorder(s) that would interfere with the patient’s compliance.
- •9. Use of full-dose oral or parenteral anticoagulants or thrombolytic agent for therapeutic (as opposed to prophylactic) purposes.
- •10. Use of strong hepatic enzyme-inducing antiepileptic drugs, such as carbamazepine, phenobarbital and phenytoin. If a patient uses one or more of these specific antiepileptic drugs, the must switch to an antiepileptic drug that does not interact with cytochrome P450 (CYP450) liver enzymes, such as levetiracetam, prior to the start of study treatment.
- •11. Drug or alcohol abuse.
- •12. Females who are pregnant or breast-feeding.
- •13. Any evidence of a disease or condition that might affect compliance with the protocol or interpretation of the study results or render the patient at high risk from treatment complications.
- •14. Unwillingness or inability to comply with study and follow-up procedures.
- •15. Clinically significant history of liver disease, including viral or other hepatitis, current alcohol abuse, or cirrhosis.
研究者
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