EUCTR2014-001858-41-GB进行中（未招募）1 期
A Phase II Trial to Evaluate the Efficacy of AZD6094 (HMPL-504) in Patients With Papillary Renal Cell Carcinoma (PRCC) - A Phase II Trial to Evaluate the Efficacy of AZD6094 in Patients With PRCC
Astra Zeneca AB0 个研究点目标入组 90 人开始时间: 2014年12月30日最近更新:
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 90
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
- •Inclusion criteria
- •Provision of informed consent prior to any study specific procedures, sampling and analyses.
- •Histologically confirmed papillary renal cell cancer, which is locally advanced
- •Availability of an archival tumor sample or a pre-treatment fresh tumor sample for confirmation of PRCC by a central laboratory and other biomarker
- •Treatment naive or who have failed on treatment for PRCC.
- •Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
- •At least one lesion, not previously irradiated, and not chosen for a biopsy if performed during the screening period that can be accurately measured at baseline and which is suitable for accurate repeated measurements.
- •Adequate hematological function defined as:
- •a.(ANC) =1500/µL
- •b.(Hgb) =9 g/dL
- •c.Platelets =100,000/µL
- •Adequate liver function defined as:
- •a.(ALT) and (AST) =2.5 xthe upper limit of normal (ULN)
- •b.Total bilirubin =1.5 x ULN
- •Adequate renal function defined as glomerular filtration rate (GFR) = 30 mL/min,
- •Adequate coagulation parameters, defined as International Normalisation Ratio(INR) <1.5 x ULN or activated partial thromboplastin time (aPTT) <1.5 x ULN.
- •Patients with known tumor thrombus or deep vein thrombosis (DVT) are eligible if stable on low molecular weight heparin (LMWH) for =2 weeks.
- •Females should be using adequate contraceptive measures should notbe breast feeding, and must have a negative pregnancy test prior to start of dosing ifof childbearing potential or must have evidence of non-childbearing potential
- •Male patients should be willing to use barrier contraception, i.e. condoms, during the study and for 6 months following discontinuation of study drug.
- •Ability to swallow and retain oral medications.
- •Predicted life expectancy =12 weeks.
- •Aged at least 18 years.
- •Willingness and ability to comply with study and follow-up procedures.
- •Ability to understand the nature of this study and give written informed consent.
- •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 50
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 25
排除标准
- •Exclusion criteria
- •Most recent chemotherapy, immunotherapy, chemo-immunotherapy, or investigational agents <21 days of the first dose of study treatment. Most recent targeted therapy <14 days of the first dose of study treatment.
- •Unresolved toxicities from any prior therapy greater than Common Terminology Criteria for Adverse Events (CTCAE) Grade 1 at the time of starting study treatment with the exception of alopecia.
- •Prior or current treatment with a cMet inhibitor (e.g. Foretinib, Crizotinib, Cabozantinib, Onartuzumab). Patients with limited exposure may be discussed with the study medical monitor.
- •Strong inducers or inhibitors of CYP3A4, strong inhibitors of CYP1A2, or CYP3A4 substrates with a narrow therapeutic range within 2 weeks before the first dose of study treatment (3 weeks for St John’s Wort)
- •Known hypersensitivity to the active or inactive excipients of AZD 6094.
- •Wide field radiotherapy (including therapeutic radioisotopes such as strontium 89) administered =28 days or limited field radiation for palliation =7 days prior to starting study drug or has not recovered from side effects of such therapy
- •Major surgical procedures =28 days of beginning study drug or minor surgical procedures =7 days. No waiting is required following port-a-cath placement.
- •Previously untreated brain metastases.
- •Current leptomeningeal metastases or spinal cord compression due to disease.
- •Acute or chronic liver or pancreatic disease.
- •Uncontrolled diabetes mellitus.
- •Gastrointestinal disease or other condition that will interfere significantly with the absorption, distribution, metabolism, or excretion of oral therapy
- •Any of the following cardiac diseases currently or within the last 6 months:
- •a.Unstable angina pectoris
- •b.Congestive heart failure (New York Heart Association [NYHA] = Grade 2
- •c.Acute myocardial infarction
- •d.Stroke or transient ischemic attack
- •Inadequately controlled hypertension (i.e., systolic blood pressure [SBP] >160 mmHg or diastolic blood pressure (DBP) >100 mmHg) (patients with values above these levels must have their blood pressure (BP) controlled with medication prior to starting treatment).
- •Mean resting correct QT interval (QTc) >470 msec obtained from triplicate ECGs.
- •Any clinically important abnormalities in rhythm, conduction or morphology of resting electrocardiograms (ECGs), e.g. complete left bundle branch block, third degree heart block, second degree heart block, PR interval >250 msec.
- •Any factors that increase the risk of QTc prolongation or risk of arrhythmic events such as heart failure, hypokalaemia, congenital or familial long QT syndrome or family history of unexplained sudden death under 40 years of age or any concomitant medications known to prolong QT interval.
- •Currently receiving treatment with therapeutic doses of warfarin sodium. Low molecular weight heparin (LMWH) is allowed.
- •Serious active infection at the time of treatment, or another serious underlying medical condition that would impair the ability of the patient to receive protocol treatment.
- •Known diagnosis of human immunodeficiency virus (HIV), hepatitis B, or hepatitis C.
- •Presence of other active cancers, or history of treatment for invasive cancer =5years. Patients with Stage I cancer who have received definitive local treatment at least 3 years previously, and are considered unlikely to recur are eligible. All patients with previously treated in situ carcinoma (i.e., non-invasive) are eligible, as are
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