EUCTR2013-003306-45-DE进行中（未招募）1 期
An open-label, uncontrolled, single arm phase II trial of BKM120 (Buparlisib) in patients with metastatic melanoma with brain metastases not eligible for surgery or radiosurgery
niversitätsklinikum Tübingen0 个研究点目标入组 22 人开始时间: 2014年12月11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
- 22
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
- •Patients eligible for inclusion in this study have to meet all of the following criteria:
- •1.Patient has signed the Informed Consent (ICF) prior to any screening procedures being performed and is able to
- •comply with protocol requirements.
- •2.Patient has adequate bone marrow and organ function as defined by the following laboratory values;
- •(Clinical labs – performed within 14 days prior to enrollment)
- •a.Absolute Neutrophil Count (ANC) = 1.0 x 109/L
- •b.Platelet count = 100 x 109/L (For patients with hematologic malignancies involving the bone marrow, platelet
- •count > 75 x 109/L)
- •c.Hemoglobin = 9.0 g/dL
- •Coagulation
- •d.INR = 1.5
- •Biochemistry
- •e.Potassium and calcium (corrected for albumin), within normal limits for the institution, or = Grade 1 if judged not
- •clinically significant by the investigator
- •f.Serum creatinine = 1.5 x ULN and/or creatinine clearance > 50% LLN (Lower Limit of Normal)
- •g.Total Serum bilirubin = ULN (or <1.5 x ULN if liver metastases are present; or total bilirubin = 3.0 x ULN with direct
- •bilirubin within normal range in patients with well documented Gilbert’s Syndrome, which is defined as presence of
- •several episodes of unconjugated hyperbilirubinemia with normal results from CBC count (including normal
- •reticulocyte count and blood smear), normal liver function test results, and absence of other contributing disease
- •processes at the time of diagnosis
- •h.AST (SGOT) and ALT (SGPT) below or equal upper limit of normal range or (= 3.0 x ULN if liver metastases are
- •i.Fasting plasma glucose (FPG) = 120mg/dL or = 6.7 mmol/L
- •j.HbA1c = 8%
- •3.Patient is able to swallow and retain oral medication
- •4.Patient must be at least 18 years old
- •5.Patient must have an estimated life expectancy > 8 weeks in the opinion of the investigator
- •6.Patient must have ECOG performance status < 2
- •Nature of illness and treatment history
- •7.Histologically confirmed diagnosis of melanoma
- •8.Patient must has shown evidence for PD in the brain by MRI without leptomeningeal disease
- •9.Contrast enhanced brain MRI and CT for chest / abdomen / pelvis or MRI for abdomen / pelvis must be performed
- •within 28 days before first dose of study treatment
- •10.Patient is able to be assessed by periodic MRI and CT scan
- •11.Patients BRAF V600 wildtype:
- •-must have objective evidence of progressive disease during or
- •-following treatment with Checkpoint-inhibitors for advanced melanoma
- •12.Patients BRAF V600 mutation positive:
- •-must have objective evidence of progression of disease during or
- •-following treatment with a BRAF inhibitor
- •-not be eligible for surgery or radiosurgery
- •13.Time interval between last day of previous anti-tumour local or systemic treatment and first dose of buparlisib:
- •-14 days elapsed from last treatment with surgery or radiosurgery
- •-28 days elapsed from last treatment with whole brain radiation
- •-28 days have elapsed from last dose of approved or investigational chemo-, cytokine-, immune-, biological-, or vaccine-therapy
- •14.Participants must have recovered to a grade 0 or 1 from the toxic effects of prior therapy
- •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 14
- •F.1.3 Elderly (>=65 years) no
- 另有 1 项未显示
排除标准
- •1.Patient has a known hypersensitivity to any of the excipients of buparlisib
- •2.Patient who has received wide field radiotherapy = 4 weeks or limited field radiation for palliation = 2 weeks prior
- •to starting study drug or who have not recovered to Grade 1 or better from related side effects of such therapy (except alopecia)
- •3.Patient has not recovered to Grade 1 or better (except alopecia) from related side effects of any prior antineoplastic therapy
- •4.Patient has had major surgery within 14 days prior to starting study drug or has not recovered from major side effects
- •5.Patient is currently receiving increasing or chronic treatment (> 5 days) with corticosteroids or another immunosuppressive agent
- •a.The following uses of corticosteroids are permitted: single doses; e.g. with standard premedication for taxanes;
- •topical applications (e.g., rash), inhaled sprays (e.g., obstructive airways diseases), eye drops or local injections
- •b.Patient taking an enzyme-inducing anti-epileptic drug (EIAED): phenobarbital, phenytoin, fosphenytoin, primidone,
- •rufinamide carbamazepine, oxcarbazepine, eslicarbazepine, felbamate, and topiramate (only when daily dose
- •exceeds 200 mg). Participant must be off any EIAEDs for at least two weeks prior to starting study
- •c.Requirement of more than 4 mg dexamethasone daily
- •6.Patient is being treated at start of study treatment with any of the following drugs:
- •a.Drugs known to be strong inhibitors or inducers of isoenzyme CYP3A including herbal medications.
- •b.Drugs with a known risk to induce Torsades de Pointes (List of prohibited QT prolonging drugs
- •c.Note: The patient must have discontinued strong inducers for at least one week and must have discontinued
- •strong inhibitors before the treatment is initiated. Switching to a different medication prior to starting study
- •treatment is allowed.
- •d.Patient who has received prior treatment with a PI3K inhibitor, AKT inhibitor or mTOR inhibitor
- •e.Patient who have received anti-angiogenic or anti-VEGF targeted agents
- •7.Patient is currently receiving warfarin or any other coumarin-derivative anticoagulant for treatment, prophylaxis or otherwise.
- •Therapy with heparin, low molecular weight heparin (LMWH), or fondaparinux is allowed
- •8.Patient who has who have other concurrent severe and/or uncontrolled medical conditions that would, in the
- •investigator’s judgment, contraindicate patient participation in the clinical study (e.g., active or uncontrolled
- •severe infection, chronic active hepatitis, immuno-compromised, acute or chronic pancreatitis, uncontrolled high
- •blood pressure, interstitial lung disease, etc.)
- •9.Patient has a known history of human immunodeficiency virus (HIV) infection (testing not mandatory)
- •10.Patient has any of the following cardiac abnormalities:
- •a.symptomatic congestive heart failure
- •b.Myocardial infarction < 6 months prior to enrolment
- •c.unstable angina pectoris
- •d.serious uncontrolled cardiac arrhythmia
- •e.Symptomatic pericarditis
- •f.QTcF > 480 msec on the screening ECG (using the QTcF formula)
- •g.Currently receiving treatment with medication that has a known risk to prolong the QT interval or inducing
- •Torsades de Pointes, and the treatment cannot be discontinued or switched to a different medication prior to starting study drug.
- •11.Patient has impairment of gastrointestinal (GI) function or GI disease that may significant
研究者
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