NL-OMON40550已完成不适用
A phase Ib, open-label study of oral BGJ398 in combination with oral BYL719 in adult patients with select advanced solid tumors - BGJ398 in combination with BYL719 in advanced solid tumors
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
- 2
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
- •* Histologically/cytologically confirmed advanced or metastatic solid tumors who have failed standard therapy or for whom no effective standard anticancer therapy exists ;* Documented PIK3CA mutations in all patients in dose escalation and expansion with or without documented genetic alterations in FGFR depending upon dose expansion cohort (either local or central determination);* Measurable disease defined by RECIST v1.1 ;* ECOG performance status of *2
排除标准
- •* Prior PI3Ki or selective FGFR inhibitor treatment (for patients enrolled to expansion part) ;* Ongoing grade 2 or greater sequelae from previous systemic anti-cancer therapies, except for:
- •alopecia and stable neuropathy of * grade 2 ;* History and/or current evidence of tissue calcification;* Patients with diabetes mellitus requiring insulin treatment or with fasting glucose * 140 mg/dL / 7.8 mmol/L, ;* Known acute or chronic pancreatitis;* Treatment with chronic systemic corticosteroids * 2 weeks prior to starting study drug,
- •* Impairment of gastrointestinal tract function or GI disease that may significantly alter the absorption of BGJ398 or BYL719;* History and/or current evidence of endocrine alterations of calcium/phosphate homeostasis, e.g., parathyroid disorders, history of parathyroidectomy, tumor lysis etc;* Confirmed evidence of corneal or retinal disorder;* Treatment with agents that are known strong inducers or inhibitors CYP3A4 are prohibited. ;* Insufficient bone marrow function:
- •-ANC <1,000/mm3 [1.0 x 109/L]
- •-Platelets < 75,000/mm3 [75 x 109/L]
- •-Hemoglobin < 9.0 g/dL;* Insufficient hepatic and renal function
- •-Total bilirubin > 1.5x ULN
- •-AST/SGOT or ALT/SGPT > 3x ULN (AST or ALT > 5x ULN in the presence of liver metastases)
- •-Serum creatinine > ULN
- •-Calculated or measured creatinine clearance < 75% LLN;* Calcium-phosphate homeostasis
- •-Inorganic phosphorus outside of normal limits
- •-Total and ionized serum calcium outside of normal limits;* Clinically significant cardiac disease including any of the following:
- •- Congestive heart failure requiring treatment (NYHA grade * 2),
- •- LVEF < 50% (MUGA or ECHO),
- •- History or presence of clinically significant ventricular arrhythmias, atrial fibrillation, resting bradycardia, or conduction abnormality,
- •- Unstable angina pectoris or acute myocardial infarction * 3 months prior to starting study drug,
- •- QTcF > 450 msec, history of congenital long QT syndrome
研究者
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