NL-OMON45098已完成不适用
A Phase Ib/II, open-label, multicenter study of INC280 in combination with buparlisib in adult patients with recurrent glioblastoma - Phase Ib/II trial: INC280 and BKM120 in recurrent glioblastoma
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- ovartis
- 入组人数
- 10
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 99（—）
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 I: 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;
- •*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.
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 (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.
- •* Receiving treatment with long acting proton pump inhibitors, and cannot be discontinued 3 days prior to the start of INC280 treatment and 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 ULN
- •*Serum creatinine >1.5 x ULN or creatinine clearance * 45 mL/min
- •*Alanine aminotransferase (AST) or aspartate aminotransferase (ALT) > 3.0 ULN (or > 5.0 x ULN if liver metastases are present)
- •*Fasting plasma glucose > 120mg/dL or > 6.7 mmol/L
- •*HbA1c > 8%.
- •* Pregnant or nursing (lactating) women
研究者
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