NL-OMON43929招募中不适用
A Phase I open-label dose escalation study with expansion to assess the safety and tolerability of INC280 in patients with c-MET dependent advanced solid tumors - A phase I study with INC280 in c-MET dependent solid tumors
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- ovartis
- 入组人数
- 16
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
- •- Advanced solid tumors with confirmed c-MET dysregulation and for whom no currently available therapy excists
- •- Previous anti-cancer and investigational therapy must be discontinued for at least 28 days before start study treatment, (6 weeks for GBM patients that received nitrosoureas), previous anti-body therapy for at least 60 days before start of study treatment and must have recovered fully from the adverse effects of such treatment before start study treatment.
- •- ECOG performance status <= 2
- •- Laboratory values:
- •Hemoglobin > 9 g/dL (5,58 mmol/l) without transfusion support or growth factors within 10 days of starting INC280
- •Platelet count >= 75 x 109/L
- •Absolute neutrophil count (ANC) >= 1.2 x 109/L without growth factor support
- •Total bilirubin <= 2 x upper limit of normal (ULN)
- •AST/SGOT and/or ALT/SGPT <= 2.5 x upper limit of normal (ULN) or <= 5.0 ULN if HCC is primary disease or liver metastases are present
- •Serum creatinine <= 2 x ULN
- •Asymptomatic serum amylase <= grade 2
- •Patients with grade 1 or grade 2 serum amylase at the beginning of the study must be confirmed to have no signs and/or symptoms suggesting pancreatitis or pancreatic injury
- •Serum lipase <= ULN
- •Fasting serum triglyceride level <= 500 mg/dL
- •-Patients with GBM must have radiographic evidence of recurrent tumor and must be at least 12 weeks post radiation therapy (XRT).;Additional inclusion criteria for NSCLC patients EGFRwt with high c-MET expression:
- •a. Written documentation of EGFRwt NSCLC.
- •b. c-MET positivity as defined by c-MET IHC intensity score +3 in >= 50% of tumor cells performed through a Novartis designated central laboratory.
- •c.No more than three prior lines of antineoplastic therapy for NSCLC.;Other protocol-defined inclusion citeria may apply. See protocol page 49
排除标准
- •- HCC with liver dysfunction greater than Child-Pugh A.
- •- Previous treatment with a c-MET inhibitor or HGF-targeting therapy.
- •- Symptomatic CNS metastases that are neurologically unstable or requiring increasing doses of steroids to control their CNS disease.
- •- Any CNS deficits. For patients with GBM, CNS symptoms grade 2 or greater.
- •- Receiving anti-epileptic drugs that are known to be strong inducers of CYP3A4.
- •- Prior or current anti-angiogenic therapy for patients with GBM.
- •- Radiation therapy within <= 4 weeks (<12 for GBM) or limited field radiotherapy within <=2 weeks (<12 weeks GBM) prior to the start of study treatment. Any persistent side effect of prior radiotherapy must be resolved to <= Grade 1 prior to the first dose of study drug. ;Additional exclusion criteria for patients of the expansion group with NSCLC EGFRwt and high c-MET expression :
- •a. Any unresolved toxicity (CTCAE grade > 1) from previous anti-cancer therapy or radiotherapy, except alopecia.
- •b. Anti-cancer therapies within the following time frames prior to the first dose of study treatment:
- •Conventional cytotoxic chemotherapy: <=4 weeks (<=6 weeks for nitrosoureas and mitomycin-C)
- •Biologic therapy (e.g., antibodies): <=4 weeks
- •Non-cytotoxic small molecule therapeutics: <=5 half-lives or <=2 weeks (whichever is longer)
- •Other investigational agents: <=4 weeks
- •Radiation therapy (palliative setting is allowed.): <=4 weeks
- •Major surgery: <=2 weeks;Other protocol-defined exclusion criteria may apply. See protocol page 50-51
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