NL-OMON50728已完成2 期
A phase II/III study of high-dose, intermittent sunitinib in patients with recurrent GBM - Phase II/III study of high-dose, intermittent sunitinib in recurrent GBM
适应症
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 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
入排标准
- 年龄范围
- 18 至 99（—）
入选标准
- •1. Signed (by the patient or legally acceptable representative) and dated
- •Informed Consent Form
- •2. Histologically confirmed primary 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:
- •a. Hemoglobin >= 7.0 mmol/L
- •b. Absolute neutrophil count (ANC) >= 1.5 x 109/L
- •c. Platelet count >= 100 x 109/L
- •d. ALAT and ASAT <= 2.5 x ULN
- •e. Serum creatinine eGFR >= 50 ml/min
- •f. 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
- •10. Patients must be able to swallow oral medication.
排除标准
- •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
- •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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