NL-OMON36264撤回2 期
A Phase II multi-center, non-randomized, open-label study of TKI258 in patients with either FGFR3 mutated or FGFR3 wild type advanced urothelial carcinoma. - TKI258 in advanced urothelial carcinoma
适应症
试验速览
- 阶段
- 2 期
- 状态
- 撤回
- 发起方
- ovartis
- 入组人数
- 4
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.Histological confirmation of transitional cell carcinoma of the bladder, urethra, ureter, or renal pelvis
- •* Locally advanced or metastatic disease
- •2. Archival tumor tissue available FGFR3 mutational status analysis
- •3. Documented progressive disease at baseline
- •4. At least one measurable site of disease as defined by RECIST
- •5. Previously treated with at least 1 but not more than 3 systemic cytotoxic regimens, at least one of the following: cisplatin, carboplatin,gemcitabine or taxane
- •6. WHO Performance Status * 2
- •7. Required baseline laboratory values:
- •* Absolute neutrophil count (ANC) * 1.5 x 109/L
- •* Platelets * 100 x 109/L
- •* Hemoglobin * 9.0 g/dL [5,58 mmol/L]
- •* AST/SGOT and ALT/SGPT * 3.0 x Upper Limit of Normal [ULN] (or AST/SGOT and ALT/SGPT * 5 x ULN if abnormal liver function is due to tumor involvement of the liver)
- •* Bilirubin * 1.5 x ULN
- •* Serum creatinine * 1.5 x ULN
排除标准
- •1.Patients with known brain metastases or who have signs/symptoms attributable to brain
- •metastases.
- •2. History of another malignancy < three years prior to study entry, with the exception of adequate treated basal cell carcinoma, squamous cell carcinoma or non-melanomatous skin cancer, excised carcinoma in situ of the cervix, or adenocarcinoma of the prostate.
- •3. Anti-cancer therapy and radiation for palliation * 14 days prior to starting study drug.
- •4. Nitrosourea or mitomycin-C * 6 weeks prior to starting study drug.
- •5. Anti-cancer monoclonal antibody * 6 weeks prior to starting study drug.
- •6. Wide field radiotherapy * 4 weeks to starting study drug.
- •7. Major surgery * 2 weeks prior to starting study drug.
- •8. Any of the following concurrent severe and/or uncontrolled medical conditions:
- •a) Impaired cardiac function or clinically significant cardiac diseases, including any of the following:
- •* History or presence of serious ventricular arrhythmias or serious atrial fibrillation
- •* Clinically significant bradycardia
- •* LVEF < 45 %
- •* myocardial infarction, severe/unstable angina, Coronary Artery Bypass Graft, Congestive Heart Failure, Cerebrovascular Accident (CVA), Transient Ischemic Attack (TIA), Pulmonary Embolism within 6 months prior to study entry:
- •* Uncontrolled hypertension (Systolic BP * 160 mm Hg and/or Diastolic BP * 100 mm Hg), with or without anti-hypertensive medication. Initiation or adjustment
- •of antihypertensive medication(s) is allowed prior to study entry.
- •b) Previous pericarditis; clinically significant pleural effusion in the previous 12 months
- •or current ascites requiring two or more interventions/month
- •c) Impairment of gastrointestinal function that may alter the absorption of TKI258.
- •d) Known diagnosis of HIV infection.
- •e) History of alcoholism, drug addiction, or any psychiatric or psychological condition
- •f) Therapeutic doses of warfarin
- •g) Uncontrolled diarrhea * CTCAE grade 2
- •h) Pregnant or breast-feeding women.
- •i) Male or female not willing to use adequate contraceptive protection (when applicable)
研究者
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