EUCTR2011-005912-27-GB进行中（未招募）1 期
A RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, MULTICENTER PHASE II STUDY EVALUATING THE EFFICACY AND SAFETY OF ONARTUZUMAB IN COMBINATION WITH BEVACIZUMAB OR ONARTUZUMAB MONOTHERAPY IN PATIENTS WITH RECURRENT GLIOBLASTOMA
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 129
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
入选标准
- •1. Histologically confirmed glioblastoma at first recurrence after concurrent or adjuvant chemoradiotherapy
- •A local pathology report constitutes adequate documentation of histology for study inclusion. Patients with an initial diagnosis of a lower-grade glioma are eligible if a subsequent biopsy was determined to be glioblastoma.
- •2. Imaging confirmation of first tumor progression or regrowth as defined by the RANO criteria
- •A minimum of 12 weeks must have elapsed from the completion of
- •radiotherapy to randomization to minimize the potential for magnetic resonance imaging (MRI) changes related to radiation necrosis that might be misdiagnosed as progression of disease, unless there is a new lesion outside the radiation field or unequivocal evidence of viable tumor on histopathological sampling.
- •3. Prior treatment with TMZ
- •4. No more than one prior line of chemotherapy
- •Concurrent and adjuvant TMZ-based chemotherapy, including the
- •combination of TMZ with an investigational agent, is considered one line of chemotherapy.
- •5. No prior treatment with bevacizumab or other VEGF- or
- •VEGF-receptor-targeted agent
- •6. No prior exposure to experimental treatment targeting either the HGF or Met pathway
- •7. Prior therapy with gamma knife or other focal high-dose radiotherapy is allowed, but the patient must have subsequent histologic documentation of recurrence, unless the recurrence is a new lesion outside the irradiated field
- •8. No prior treatment with prolifeprospan 20 with carmustine wafer
- •9. No prior intracerebral agent
- •Recovery from the toxic effects of prior therapy, with a minimum time of:
- •a) = 28 days elasped from the administration of any investigational agent
- •b) = 28 days elapsed from the administration of any prior cytotoxic agents, except = 14 days from vincristine, = 21 days from procarbazine, and = 42 days from nitrosureas
- •c) = 7 days elapsed from administration of any non-cytotoxic agent (e.g., interferon, tamoxifen, thalidomide, cis-retinoic acid)
- •11. Patients who have undergone recent surgery for recurrent or progressive tumor are eligible provided that:
- •a) Surgery must have confirmed the recurrence.
- •b) A minimum of 28 days must have elapsed from the day of surgery to randomization. For core or needle biopsy, a minimum of 7 days must have elapsed prior to randomization.
- •c) Craniotomy or intracranial biopsy site must be adequately healed and free of drainage or cellulitis, and the underlying cranioplasty must appear intact at the time of randomization.
- •12. No evidence of recent hemorrhage on baseline MRI of the brain
- •However, patients with clinically asymptomatic presence of hemosiderin, resolving hemorrhagic changes related to surgery, or presence of punctuate hemorrhage in the tumor are eligible.
- •13. No need for urgent palliative intervention for primary disease
- •(e.g., impending herniation)
- •14. Availability of formalin-fixed paraffin-embedded tumor tissue representative of glioblastoma
- •15. Willingness and ability to provide written informed consent and to
排除标准
- •1. Patients unable to undergo brain MRI scans with IV gadolinium
- •2. Pregnancy or lactation (or a positive pregnancy test within 7 days before starting any component of study medication)
- •3. Absolute neutrophil count (ANC) < 1.5 × 109/L; platelet count < 100 × 109/L; or hemoglobin (Hb) < 9.0 g/dL within 7 days prior to enrollment Note: The use of transfusion or other intervention to achieve Hb = 9 g/dL is acceptable.
- •4. Total bilirubin = 1.5 × ULN (except in patients diagnosed with Gilbert’s disease)
- •5. AST (SGOT), ALT (SGPT), or alkaline phosphatase (ALP) = 2.5 ×ULN
- •6. Serum creatinine > 1.5 × ULN or calculated creatinine clearance
- •(CrCl) < 60 mL/min (Cockcroft and Gault)
- •7. Urine dipstick test for proteinuria = 2+ Patients found to have = 2+ proteinuria should undergo a 24-hour urine collection and must demonstrate = 1.0 g of protein in 24 hours)
- •8. International normalized ratio (INR), protohrombin time (PT), or activated partial thromboplastin time (APTT) as follows:
- •In the absence of therapeutic intent to anticoagulate the patient:
- •INR > 1.5 or PT > 1.5 × ULN or aPTT > 1.5 ×ULN OR
- •In the presence of therapeutic intent to anticoagulate the patient: INR or PT and aPTT not within therapeutic limits (according to the medical standard in the institution) or patient has not been on a stable dose of anticoagulants for at least 2 weeks before randomization. (Note: Per ASCO guidelines, low-molecular-weight heparin [LMWH] should be the preferred approach.)
- •9. Inadequately controlled hypertension (defined as systolic blood pressure >150 mmHg and/or diastolic blood pressure >100 mmHg while on antihypertensive medication)
- •10. Uncontrolled diabetes, as evidenced by fasting serum glucose level > 200 mg/dL
- •11. Prior history of hypertensive crisis or hypertensive encephalopathy
- •12. New York Heart Association (NYHA) Grade II or greater congestive cardiac failure
- •13. History of myocardial infarction (within 12 months) or unstable angina (within 6 months) prior to randomization
- •14. History of stroke or transient ischemic attacks within 6 months prior to randomization
- •15. Significant vascular disease (e.g., aortic aneurysm requiring surgical repair or recent peripheral arterial thrombosis) within 6 months prior to randomization
- •16. Evidence of bleeding diathesis or coagulopathy (in the absence of therapeutic anticoagulation)
- •17. History of abdominal fistula or gastrointestinal perforation within 6 months prior to randomization
- •18. History of intracranial abscess within 6 months prior to randomization
- •19. Major surgical procedure, open biopsy, or significant traumatic injury within 28 days prior to randomization
- •20. Anticipation of need for major surgical procedure during the course of the trial
- •21. Serious non-healing wound, active ulcer, or untreated bone fracture
- •22. History of another malignancy in the previous 3 years, with a disease-free interval of < 3 years
- •Patients with prior history of in situ cancer or basal or squamous cell skin cancer are eligible.
- •23. Evidence of any active
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