NL-OMON30887已完成不适用
A Phase IB, study to investigate the effect of ketoconazole, a CYP3A4 inhibitor, on oral LBH589 and to assess the efficacy and safety of oral LBH589 in patients with advanced solid tumors - A drug-drug interaction study with LBH589 and ketoconazol
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
- 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
- •* Histologically proven solid tumor which is advanced or metastatic as documented by CT-scan or MRI
- •* Patients with non-Hodgkin*s lymphoma should have at least one measurable or evaluable lesions (Cheson response criteria for NHL )
- •* Patient*s disease must have progressed on or following standard therapies.
- •* ECOG performance status of * 2.
- •* Life expectancy of * 12 weeks.
- •* Patients must have the following lab results:
- •- Absolute neutrophil count (ANC) * 1.5 x 10 9/L
- •- Hemoglobin (Hgb) * 9g/dl
- •- Platelets (plt) * 100 x 109/L
- •- AST/SGOT and ALT/SGPT * 2.5 x upper limit of normal (ULN); if known with liver metastases: AST/SGOT and ALT/SGPT * 5.0 x (ULN)
- •- Serum bilirubin * 1.5 x ULN
- •- Calculated creatinine clearance * 50 ml/min
- •- Free T4 within normal limit (WNL) and TSH * ULN
- •- Serum potassium * the lower limit of normal (LLN)
- •- Serum total calcium, magnesium and phosphorus * LLN
- •* Screening ECG with a QTc * 450 msec.
- •* Negative serum or urine pregnancy test 72 hours prior to the administration of the first study treatment.
- •* Baseline LVEF * the lower limit of the institutional normal
排除标准
- •* CNS involvement or brain metastases.
- •* Chronic liver toxicity
- •* Impairment of gastrointestinal (GI) function or GI obstruction that may significantly alter the absorption of oral LBH589.
- •* Diarrhea >CTCAE grade 1
- •* Current chemotherapy, immunotherapy, or radio-therapy or within 4 weeks prior to study entry.
- •* Prior treatment with a HDAC inhibitor including valproic acid within 14 days prior to first dose of LBH589.
- •* Significant cardiac disease, including any one of the following:
- •- Congenital long QT syndrome, history of sustained ventricular tachycardia, history of ventricular fibrillation or torsades de pointes, bradycardia (<50 beats per minute), patients with pacemakers are eligible if HR*50 bpm, right bundle branch block and left anterior hemiblock, myocardial infarction or instable angina within 6 months of study entry, congestive heart failure (NY Heart Association class III or IV)
- •* Uncontrolled hypertension
- •* Concomitant use of drugs with a risk of causing torsades de pointes
- •* Concomitant use of CYP3A4/5 inhibitors or inducers (core phase only)
- •* Other concurrent severe and/or uncontrolled medical conditions
- •* Chemotherapy or major surgery * 4 weeks prior to starting study drug
- •* Targeted therapy * 2 weeks or * 5 half-lives of the active drug or active metabolites
- •* Wide-field radiotherapy * 4 weeks or limited-field radiation for palliation * 2 weeks prior to starting study drug
- •* Female patients who are pregnant, or have a positive serum pregnancy test during screening or breast feeding or patients of reproductive potential not using an effective method of birth control.
- •* Male patients whose sexual (childbearing potential) partners are not using effective birth control
- •* HIV or hepatitis C* Any active or uncontrolled severe infections.
研究者
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