NL-OMON39786已完成不适用
A multi-center, open-label study to assess pharmacokinetics of TKI258 in adult cancer patients with normal and impaired hepatic function - TKI258 hepatic impairment trial
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
- 7
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
- •1. Patients with histologically or cytologically confirmed solid tumor, excluding breast cancer and lymphoma, that is either refractory to the standard therapy or has no available therapies. HCC patients with a diagnosis of advanced HCC according to the AASLD guidelines (Bruix and Sherman 2010)
- •2. Male or female patients * 18 years old
- •3. Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0, 1 or 2
- •4. Patients must meet the following criteria for laboratory values:
- •a. Absolute neutrophile count (ANC) * 1.5 x 109/L
- •b. Platelets * 75 x 109/L
- •c. Hemoglobin * 9 g/dL
- •d. Total bilirubin and ALT/AST levels as described in Table 5-1
- •e. Serum creatinine * 1.5 x ULN
- •f. Urine dipstick reading: Negative for proteinuria or, if documentation of +1 results for protein on dipstick reading, then total urinary protein * 500 mg and measured creatinine clearance * 50 mL/min/1.73m3 from a 24 hour urine collection
- •5. Patients must have measurable and/or non-measurable lesion(s) as assessed by Computer Tomography (CT) Scan or Magnetic Resonance Imaging (MRI) per RECIST 1.1
- •6. Patients who give a written informed consent obtained according to local guidelines
排除标准
- •1. Patients with known brain metastases or who have signs/symptoms attributable to brain metastases and have not been assessed by radiologic imaging (e.g. CT or MRI scan) to rule out the presence of metastases.
- •2. Patients who have received the last administration of chemotherapy or immunotherapy or hormone therapy the timeframe defined below after the end of the last treatment Cycle (prior to starting study drug), or who have not recovered from the side effects of such therapy:
- •a. Last administration of chemotherapy/immunotherapy/hormone therapy in a daily schedule * 7 days prior to starting study treatment
- •b. Last administration of chemotherapy/immunotherapy/hormone therapy in a weekly schedule * 2 weeks prior to starting study treatment
- •c. Last administration of chemotherapy/immunotherapy/hormone therapy in a 2-weekly schedule * 3 weeks prior to starting study treatment
- •d. Last administration of chemotherapy/immunotherapy/hormone therapy in a 3-weekly schedule * 4 weeks prior to starting study treatment
- •e. Last administration of chemotherapy/ immunotherapy/hormone therapy in a 4-weekly schedule * 5 weeks prior to starting study treatment
- •f. Last administration of nitrosourea, mitomycin-C * 6 weeks prior to starting study treatment
- •3. Patients who received small molecule targeted agents * 2 weeks prior to starting study treatment
- •4. Patients who have received radiotherapy * 4 weeks prior to starting the study treatment or who have not recovered from radiotherapy-related toxicities. Palliative radiotherapy for bone lesions * 2 weeks prior to starting study treatment is allowed
- •5. Patients who have undergone major surgery (e.g., intra-thoracic, intra-abdominal or intra-pelvic) * 4 weeks prior to starting study treatment or who have not recovered from side effects of such therapy
- •6. Patients with another primary malignancy within 3 years prior to starting study drug, with the exception of adequately treated in-situ carcinoma of the uterine cervix, basal or squamous cell carcinoma or non-melanomatous skin cancer
- •7. Impaired cardiac function or clinically significant cardiac diseases, including any of the following:
- •a. History or presence of serious uncontrolled ventricular arrhythmias
- •b. Clinically significant resting bradycardia (< 50 beats/minute)
- •c. LVEF assessed by 2-D echocardiogram (ECHO) < 50% or lower limit of normal (which ever is higher) or multiple gated acquisition scan (MUGA) < 45 % or lower limit of normal (which ever is higher)
- •d. Any of the following within 6 months prior to study entry: myocardial infarction (MI), severe/unstable angina, coronary artery bypass graft (CABG), congestive heart failure (CHF), cerebrovascular accident (CVA), transient ischemic attack (TIA)
- •e. Uncontrolled hypertension defined by a systolic blood pressure (SBP) * 160 mm Hg and/or diastolic blood pressure (DBP) * 100 mm Hg, with or without anti-hypertensive medication
- •8. Impairment of gastrointestinal (GI) function or GI disease that may significantly alter the absorption of TKI258 (e.g. ulcerative diseases, uncontrolled nausea, vomiting, diarrhea, malabsorption syndrome, or small bowel resection)
- •9. Known history of human immunodeficiency virus (HIV) seropositivity (HIV testing is not mandatory)
- •10. Other concurrent severe and/or uncontrolled concomitant medical conditions (e.g. active or uncontrolled infection, with the exception of Hepatitis B or Hepatitis C in
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