EUCTR2006-003193-10-FR进行中（未招募）1 期
A phase I/II study of oral PHA-848125AC given daily for 14 consecutive days every 3 weeks in recurrent malignant glioma
erviano Medical Sciences S.r.l.0 个研究点目标入组 70 人开始时间: 2007年5月22日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 70
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
- •Phase I part:
- •1.Signed and dated IRB/IEC-approved Informed Consent
- •2.Histologically proven supratentorial brain tumor (e.g. anaplastic astrocytoma [WHO grade III], recurrent or progressive low-grade glioma, oligodendroglioma, ependymoma), at recurrence after prior standard therapy. Inclusion of other histologies possible after approval by the Investigator and the Sponsor
- •3.Recurrence or progression after prior standard treatment with surgery, if feasible, radiotherapy and chemotherapy. Patient may have received more than 1 line of prior chemotherapy
- •4.Age = 18 years
- •5.KPS = 70
- •6.Estimated life expectancy of at least 3 months
- •7.Negative pregnancy test (if female in reproductive years)
- •8.Agreement upon the use of effective contraceptive methods (hormonal or barrier method of birth control, or abstinence) prior to study entry and for the duration of study participation, if men and women of child producing potential
- •9.Adequate liver function:
- •- Bilirubin = 1.5 upper limit of normal (ULN)
- •- Albumin = 3.0 g/dL
- •- AST (SGOT), ALT (SGPT) =2.5 ULN
- •- Alkaline phosphatase = 2.5 ULN
- •10.Adequate renal function:
- •- Serum creatinine =1.5 mg/dL (or =133 µmol/L)
- •11.Adequate hematologic status:
- •- ANC =1,500 cells/mm3
- •- Platelet count = 100,000 cells/mm3
- •- Hemoglobin =10.0 g/dL
- •12.At the time of start of treatment, at least 4 weeks must have elapsed since completion of surgery, radiotherapy and chemotherapy (at least 6 weeks since completion of prior nitrosurea therapy)
- •13.With the exception of alopecia, resolution of all acute toxic effects of any prior surgery, radiotherapy, radiosurgery or chemotherapy to NCI CTC (Version 3.0) grade = 1 and to the baseline laboratory values as defined in Inclusion Criteria Number 9, 10, 11
- •14.Concurrent corticosteroids allowed, with dose stable for at least 7 days before treatment
- •15.Able and willing to comply with scheduled visits, therapy plans, and laboratory tests required in this protocol
- •16.Capability to swallow capsules intact (without chewing, crushing, or opening)
- •17.If on treatment with antiepileptic drugs (AEDs), AEDs should be non enzyme-inducing (non-EIAEDs). (Not Applicable to patients enrolled in the EIAEDs subset at the RP2D)
- •18.Patients on treatment with enzyme-inducing antiepileptic drugs (EIAEDs). (Applicable only to patients enrolled in the EIAEDs subset at the RP2D)
- •19.Patients should continue on the same anticonvulsant(s) for 2 weeks prior to treatment; patients with tumor-related tremors and/or seizures can be enrolled if well controlled by specific therapy.
- •Phase II part:
- •1.Signed and dated IRB/IEC-approved Informed Consent
- •2.Histologically proven (at diagnosis) glioblastoma (GBM)
- •3.Patients in first relapse, following 1st line chemotherapy (maximum 1 line of prior chemotherapy, either administered at initial diagnosis or at a recurrence)
- •4.Presence of at least one =1.5 cm2 bi-dimensionally measurable lesion by gadolinium (Gd)-enhanced MRI scan, indicating progressive or recurrent disease, obtained at least 12 weeks after standard external-beam radiotherapy and within 14 days prior to treatment
- •5.Age = 18 years
- •6.KPS = 70
- •7.Estimated life expectancy of at least 3 months
- •8.Negative pregnancy test (if female in reproductive years)
- •9.Agreement upon the use of effective contraceptive methods (hormonal or barrier method of birth control, or abstinence) prior to study entry and for the duration of study participation, if men and women of child-producing potential
排除标准
- •Phase I and Phase II parts:
- •The presence of any of the following will exclude a subject from study enrollment:
- •1.Grade >1 retinopathy
- •2.Any of the following in the past 6 months: myocardial infarction, unstable angina, coronary/peripheral artery bypass graft, symptomatic congestive heart failure, cerebrovascular accident or transient ischemic attack, pulmonary embolism, deep vein thrombosis
- •3.Major surgery, other than diagnostic surgery, within 4 weeks prior to treatment
- •4.Active, uncontrolled bacterial, viral, or fungal infections, requiring systemic therapy
- •5.Pregnant or breast feeding women
- •6.Known infection with HIV, active hepatitis B or hepatitis C
- •7.Prior high-dose chemotherapy with bone marrow or stem cell support
- •8.Previous (within the last 5 years) or current malignancies at other sites, except for adequately treated basal cell or squamous cell skin cancer or in situ carcinoma of the cervix uteri
- •9.Patients with extra-brain metastases
- •10.Current enrollment in or participation in another therapeutic clinical trial within 4 weeks preceeding treatment start
- •11.Diabetes mellitus uncontrolled, or with clinical evidence of diabetic retinopathy, severe peripheral vascular disease or diabetic ulcers
- •12.Patients who have exhibited allergic reactions to a similar structural compound, biological agent, or formulation or to the contrast medium
- •13.Gastrointestinal disease (e.g. Crohn’s disease, ulcerative colitis, or short gut syndrome) that would impact on drug absorption
- •14.Other severe acute or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with study participation or may interfere with the interpretation of study results and, in the judgement of the Investigator, would make the patient inappropriate for entry into this study or could compromise protocol objectives in the opinion of the Investigator and/or the Sponsor.
- •15.Patients under treatment with anticoagulants or with coagulation disorders or with signs of hemorrhage at the baseline MRI
- •16.Patients treated with drugs which might inhibit CYP3A4
- •17.Patients treated with drugs which might induce CYP3A4 (except for patients taking EIAEDs and enrolled in the EIAEDs subset at the RP2D).
研究者
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