EUCTR2008-005870-11-NL进行中（未招募）1 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 - N/A
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •1. Patients with histological confirmation of transitional cell carcinoma of the bladder,
- •urethra, ureter, or renal pelvis
- •Locally advanced or metastatic disease
- •2. Archival tumor tissue available for Novartis designated FGFR3 mutational status analysis
- •3. Patients with documented progressive disease at baseline: progressive disease defined as
- •new or progressive lesions on cross-sectional imaging
- •4. Patients with at least one measurable site of disease as defined by RECIST criteria that has
- •not been previously irradiated
- •5. Previously treated with at least 1 but not more than 3 systemic cytotoxic regimens, with at
- •least one of these regimens including at least one of the following: cisplatin, carboplatin,
- •gemcitabine or taxane, administered in the perioperative or advanced setting and may have
- •been administered sequentially (e.g., first-line treatment followed by second-line treatment
- •at time of progression) or as part of a single regimen
- •6. Age = 18 years
- •7. WHO Performance Status = 2
- •8. Willing and able to take oral medication, comply with scheduled visits, treatment plan and
- •laboratory tests
- •9. Signed and witnessed informed consent form obtained prior to any screening procedures
- •10. Required baseline laboratory values:
- •Absolute neutrophil count (ANC) = 1,500 cells/mm3 [SI units 1.5 x 109/L]
- •Platelets = 100,000 cells/mm3 [SI units 100 x 109/L]
- •Hemoglobin = 9.0 g/dL [SI units 90 g/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
- •Bilirubin = 1.5 x ULN
- •Serum creatinine = 1.5 x ULN
- •Potassium within normal limits
- •Sodium within normal limits
- •Total Calcium (corrected for serum albumin) within normal limits
- •Magnesium within normal limits
- •Phosphorus within normal limits
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range
排除标准
- •1. Patients with known brain metastases or who have signs/symptoms attributable to brain
- •metastases and have not been assessed with radiologic imaging to rule out the presence of
- •brain metastases
- •2. Patients with history of another malignancy within the last five years prior to study entry,
- •except cured basal cell carcinoma of the skin, excised carcinoma in situ of the cervix, or
- •adenocarcinoma of the prostate that has been surgically treated with a post-treatment PSA
- •that is non-detectable
- •3. Patients who have received the last administration of an anti-cancer therapy, including:
- •chemotherapy, immunotherapy, hormonal therapy, and targeted therapy, but excluding:
- •nitrosourea, mitomycin-C, monoclonal antibodies, and radiation = 14 days prior to starting
- •study drug, or who have not recovered from side effects of such therapy
- •4. Patients who have received the last administration of nitrosourea or mitomycin-C = 6
- •weeks prior to starting study drug, or who have not recovered from the side effects of such
- •5. Patients who received the last administration of an anti-cancer monoclonal antibody = 6
- •weeks prior to starting study drug, or who have not recovered from the side effects of such
- •6. Patients who have received wide field radiotherapy (including therapeutic radioisotopes
- •such as strontium 89) = 4 weeks or limited field radiation for palliation = 2 weeks prior to
- •starting study drug, or who have not recovered from the side effects of such therapy
- •7. Patients who have undergone major surgery = 2 weeks prior to starting study drug, or who
- •have not recovered from the side effects of such therapy
- •8. Any of the following concurrent severe and/or uncontrolled medical conditions which
- •could compromise participation in the study:
- •a. Impaired cardiac function or clinically significant cardiac diseases, including any of
- •the following:
- •History or presence of serious uncontrolled ventricular arrhythmias or presence
- •of serious uncontrolled atrial fibrillation
- •Clinically significant resting bradycardia
- •LVEF, assessed by 2-D echocardiogram (ECHO) or multiple gated acquisition
- •scan (MUGA), < 45 %
- •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), Pulmonary Embolism (PE)
- •Uncontrolled hypertension defined by a SBP = 160 mm Hg and/or DBP = 100
- •mm Hg, with or without anti-hypertensive medication
- •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 (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)
- •d. Known diagnosis of human immunodeficiency virus (HIV) infection (HIV testing is
- •not mandatory)
- •e. History of alcoholism, drug addiction, or any psychiatric or psychological condition
- •which, in the opinion of the investigator, would impair study compliance
- •f. Patients who are currently receiving anticoagulation treatment with therapeutic doses
- •of warfarin
- •g. Uncontrolled diarrhea = CTCAE grade 2
- •h. Other concurrent severe and/or uncontrolled concomitant medical conditions (e.g.
- •active or uncontrolled infection) that could cause unacceptable safety risks or
- •compromise com
研究者
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