EUCTR2013-000699-14-NL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
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 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 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.
- •Phase Ib: Documented evidence of PTEN mutations, homozygous deletion of PTEN or PTEN negative (H Score < 10) by IHC confirmed by local documentation (phase Ib only) or central assessment
- •Phase II: Documented evidence of PTEN mutations, homozynous deletion of PTEN or PTEN negative (H score < 10) by IHC or c-Met amplification (GCN > 5) by FISH, all assessed centrally. Fusion transcripts or mutant c-Met (based on local data) may be eligible for single agent arm after documented agreement with Novartis.
- •Must have received the following treatment for glioblastoma:
- •- Prior adjuvant treatment with radiotherapy and temozolomide;
- •- Note: A maximum of two prior chemotherapy/antibody regimens (including bevacizumab or other direct VEFG/VEGFR inhibitors) for recurrent disease are permitted.
- •Representative archival glioblastoma sample (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 60
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 40
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 or for pre-existing neoplasm transformed to glioblastoma (applicable for combination treatment arm only).
- •Receiving treatment with medications that are known strong inhibitors or inducers of CYP3A, and cannot be discontinued 7 days prior to the start of the treatment and during the course of the study.
- •Receiving treatment with medications that are known CYP3A or CYP1A2 substrates with narrow therapeutic index, and cannot be discontinued during the course of the study.
- •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 >1.5 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) > 3.0 x ULN (or > 5.0 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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