EUCTR2007-004391-39-DE进行中（未招募）不适用
A Phase I/II multi-center, open label study of TKI258 administered orally on an intermittent schedule in adult patients with advanced or metastatic Renal Cell Cancer (RCC)
ovartis Pharma Services0 个研究点目标入组 110 人开始时间: 2009年7月3日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 110
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
- •Dose escalation phase only
- •Patients with advanced or metastatic RCC for whom no other
- •therapeutic options exist (measurable lesion by RECIST is not required).
- •Dose expansion phase only
- •Patients that must have been previously treated with VEGF receptor
- •tyrosine kinase inhibitor (sunitinib and/or sorafenib) and an mTOR
- •inhibitor. However, patients previously treated with other therapies
- •(e.g. IL-2, IF-a) are also allowed to be enrolled and treated to determine
- •the effect of TKI258 in patients who had not been treated with VEGF
- •receptor tyrosine kinase inhibitor and mTOR therapy.
- •Patients of Asian ethnicity: who failed standard treatment or for whom
- •no standard treatment exists.
- •Patients with at least one measurable lesion at baseline as per the
- •RECIST criteria, either on physical exam or as determined by Computer
- •Tomography (CT) Scan or Magnetic Resonance Imaging (MRI).
- •Dose escalation and dose expansion phases
- •In order to determine and confirm the eligibility of a patient, after all
- •screening procedures are completed, a checklist of key eligibility criteria
- •must be completed manually by the investigator or designee prior to
- •administering the first dose. After all eligibility criteria have been
- •checked and it is confirmed that the patient is eligible for the trial, then
- •the patient can be enrolled.
- •Prior therapy with any prior anti-cancer agent (i.e. IL-2, Interferon, etc.)
- •is permitted as long as it is administered 14 days (6 weeks for
- •nitrosoureas or mitomycin C, and 4 weeks for any investigational agents
- •and bevacizumab) prior to first administration of TKI258 (cycle 1 day 1).
- •The only exception is made for palliative radiotherapy for symptomatic
- •bone metastases. Patients must have recovered from adverse events (to
- •grade 1 or less toxicity according to CTCAE 3.0) due to the prior anticancer
- •agents (with the exception of the GI toxicities mentioned in the
- •exclusion criteria).
- •Patients with measurable histologically or cytologically confirmed
- •progressive metastatic RCC with predominant clear cell histology
- •Age at least 18 years.
- •ECOG performance status 0 or 1.
- •Required baseline laboratory data includes:
- •Absolute neutrophil count (ANC) >= 1,500/mm3 [SI units 1.5 x
- •Platelets >= 75,000/mm3 [SI units 75 x 109/L]
- •Hemoglobin >= 8.0 gm/dL [SI units 80 gm/L]
- •Serum creatinine <= 1.5 x upper limit of normal (ULN)
- •Bilirubin <=1.5 x ULN
- •AST (SGOT) and ALT (SGPT)<= 2.5 x ULN (with or without liver
- •metastases)
- •Electrolyte levels:
- •Potassium ULN – 5.5mmol/L
- •Sodium ULN – 150mmol/L
- •Urine dipstick reading: Negative for proteinuria or, if documentation of
- •<= +2 results for protein on dipstick reading, then total urinary protein
- •= 500 mg and measured creatinine clearance = 50 mL/min from a 24-
- •hour urine collection
- 另有 9 项未显示
排除标准
- •Concurrent therapy with any other investigational agent within 28
- •days prior to baseline.
- •Women of child-bearing potential,who are biologically able to
- •conceive, not employing two forms of highly effective contraception.
- •Highly effective contraception (e.g. male condom with spermicide,
- •diaphragm with spermicide, intra-uterine device) must be used by both
- •sexes during the study and must be continued for 8 weeks after the end
- •of study treatment. Oral, implantable, or injectable contraceptives may
- •be affected by cytochrome P450 interactions, and are therefore not
- •considered effective for this study. Women of child-bearing potential,
- •defined as sexually mature women who have not undergone a
- •hysterectomy or who have not been naturally postmenopausal for at
- •least 12 consecutive months (i.e. who has had menses any time in the
- •preceding 12 consecutive months), must have a negative serum
- •pregnancy test = 72 hours prior to starting TKI258.
- •Clinically significant cardiac disease (New York Heart Association,
- •Class III or IV) or impaired cardiac function or clinically significant
- •cardiac diseases, including any one of the following:
- •LVEF assessed by 2-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)
- •Complete left bundle branch block
- •Obligate use of a cardiac pacemaker
- •Congenital long QT syndrome
- •History or presence of ventricular tachyarrhythmia
- •Presence of unstable atrial fibrillation (ventricular response > 100
- •bpm). Patients with stable atrial fibrillation are eligible, provided they do
- •not meet any of the other cardiac exclusion criteria
- •Clinically significant resting bradycardia (< 50 bpm)
- •Uncontrolled hypertension (systolic blood pressure = 150 mmHg
- •and/or diastolic blood pressure = 100 mmHg, with or without antihypertensive
- •medication).
- •QTc > 480 msec on screening ECG
- •Right bundle branch block + left anterior hemiblock (bifasicular block)
- •Angina pectoris = 3 months prior to starting study drug
- •Acute Myocardial Infarction = 3 months prior to starting study drug
- •Other clinically significant heart disease (e.g., CHF, history of labile
- •hypertension, or history of poor compliance with an antihypertensive
- •Uncontrolled infection.
- •Diabetes mellitus (insulin dependent or independent disease, requiring
- •chronic medication) with signs of clinically significant peripheral
- •vascular disease.
- •Previous pericarditis; clinically significant pleural effusion in the
- •previous 12 months or current ascites requiring two or more
- •interventions/month (in both the dose escalation and dose expansion).
- •Known pre-existing clinically significant disorder of the hypothalamicpituitary
- •axis, adrenal or thyroid glands.
- •Prior acute or chronic pancreatitis of any etiology.
- •Acute and chronic liver disease and all chronic liver impairment.
- •Malabsorption syndrome or uncontrolled gastrointestinal toxicities
- 另有 7 项未显示
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