EUCTR2013-000699-14-ES进行中（未招募）1 期
A Phase Ib/II, open-label, multicenter study of INC280 in combination with buparlisib in adult patients with recurrent glioblastoma.
ovartis Farmacéutica, S.A.0 个研究点目标入组 66 人开始时间: 2013年10月18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
- 66
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
- •? ? 18 years of age.
- •? Histologically confirmed diagnosis of glioblastoma after initial tumor resection with radiographic evidence of recurrent tumor per RANO criteria.
- •? Documented evidence of PTEN mutations, homozygous deletion of PTEN or PTEN negative by IHC confirmed by local or central assessment
- •? Must have received the following treatment for glioblastoma:
- •- Prior adjuvant treatment with radiotherapy and temozolomide;
- •- A maximum of two prior chemotherapy regimens (including bevacizumab or other direct VEFG/VEGFR inhibitors) for recurrent disease are permitted.
- •? Representative archival or newly obtained tumor sample from glioblastoma (formalin-fixed paraffine embedded tissue) must be available.
- •? ECOG performance status ? 2.
- •? Able to swallow and retain oral medication.
- •? Patients in the surgical arm only: patients with recurrent glioblastoma must be eligible for surgical resection as deemed by the site Investigator.
- •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 40
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 26
排除标准
- •? Prior or current treatment with a c-MET inhibitor or HGF-targeting therapy
- •? Prior treatment with a PI3K and/or mTOR inhibitors for glioblastoma
- •? Received radiation (including therapeutic radioisotopes such as strontium 89) therapy ? 4 weeks prior to the first dose of study treatment and have not recovered from side effects of such therapy (? Grade 1) prior to the first dose of study treatment, except for alopecia.
- •? Currently being treated with Enzyme Inducing Anti-Epileptic Drug (EIAED). If previously on an EIAED, the patient must be off of it for at least 2 weeks prior to study treatment.
- •? Currently receiving warfarin or other coumadin-derived anticoagulants for treatment, prophylaxis or otherwise.
- •? Currently receiving increasing or chronic treatment ( > 5 days) with corticosteroids or another immunosuppressive agent.
- •? History of acute or chronic pancreatitis or any risk factors that may increase the risk of pancreatitis.
- •? Active cardiac disease or a history of cardiac dysfunction.
- •? Impairment of gastrointestinal (GI) function or GI disease that might significantly alter the absorption of study drug
- •? Medically documented history of or active major depressive episode, bipolar disorder (I or II), obsessive-compulsive disorder, schizophrenia, a history of suicidal attempt or ideation, or homicidal ideation (e.g. risk of doing harm to self or others), or patients with active severe personality disorders (defined according to DSM- IV).
- •? Anxiety ? CTCAE grade 3
- •? Any of the following baseline laboratory values:
- •- Hemoglobin < 9 g/dL
- •- Platelet count < 75 x 109/L
- •- Absolute neutrophil count (ANC) < 1.0 x 109/L
- •-INR > 1.5
- •- Serum lipase > normal limits for the institution
- •- Asymptomatic serum amylase > grade 2
- •- Potassium, magnesium, and calcium (corrected for albumin) > normal limits for the institution
- •- Total bilirubin ?2 x upper limit of normal (ULN)
- •- Serum creatinine >1.5 x ULN or creatinine clearance ? 45 mL/min
- •- Alanine aminotransferase (AST) or aspartate aminotransferase (ALT) > normal range (or < 3.0 x ULN if liver metastases are present)
- •- Fasting plasma glucose > 120mg/dL or > 6.7 mmol/L
- •- HbA1c > 8%.
研究者
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