ACTRN12614000789662尚未招募2 期
A Randomised controlled Phase II trial of the pharmacodynamic effects of the heat shock protein 90 (Hsp90) inhibitor AUY922 in high-risk, localised prostate cancer
适应症
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 入组人数
- 55
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomised controlled trial
- 主要目的
- Treatment
- 盲法
- Open (masking not used)
入排标准
- 年龄范围
- 18 Years 至 o limit（—）
- 性别
- Male
入选标准
- •1.Males with localised prostate cancer and at least clinical stage T3a Or Gleason score of between 8 and 10 Or Preoperative PSA greater than or equal to 20 ng/ml AND planned for radical prostatectomy
- •2.Age greater than or equal to 18 yrs
- •3.ECOG performance 0-1
- •4.Histological confirmation of prostate cancer via a pre-treatment diagnostic transrectal ultrasound (TRUS) biopsy.
- •5.Adequate bone marrow function with platelets greater than or equal to 100 x 109/L, neutrophils greater than or equal to 1.5 x 109/L and haemoglobin greater than or equal to 90 g/L;
- •6.Adequate hepatic function with serum total bilirubin less than or equal to 1.5 x upper limit of normal range and ALT/SGPT and SGOT/AST less than or equal to 2.5x upper limit of normal range (or less than 5.0 times ULN with documented liver metastases), serum albumin greater than 25 g/L. alkaline phosphatase less than or equal to 5x upper limit of normal range, and INR less than or equal to 1.5
- •7.Adequate renal function (with calculated creatinine clearance greater than 50 ml/min based on the Cockcroft-Gault method, 24 hour urine or GFR scan) and serum creatinine greater than 1.5 x Upper Limit of Normal range (ULN);
- •8.Serum calcium, potassium and magnesium within normal range or corrected with supplements
- •9.Study treatment both planned and able to start within 7 days of randomisation.
- •10.Willing and able to comply with all study requirements, including treatment and biospecimen collection
- •11.Signed, written informed consent (main study and biospecimen banking)
排除标准
- •1.Major surgery less than or equal to 2 weeks prior to enrolment or who have not recovered from side effects of such therapy. Transrectal ultrasound (TRUS) biopsy is not considered major surgery in this study.
- •2.Known hypersensitivity to the study drug or its excipients
- •3.Patients with known disorders due to a deficiency in bilirubin glucuronidation (e.g. Gilbert’s syndrome)
- •4.Diarrhoea greater than or equal to CTCAE grade 2
- •5.Impaired cardiac function, including any one of the following:
- •a.History (or family history) of long QT syndrome
- •b.Mean QTcF greater than or equal to 450 msec on baseline ECG
- •c.History of clinically manifested ischemic heart disease less than or equal to 6 months prior to study start
- •d.History of heart failure or left ventricular (LV) dysfunction (LVEF less than or equal to 50%) by MUGA
- •e.Clinically significant ECG abnormalities
- •f.History or presence of atrial fibrillation, atrial flutter or ventricular arrhythmias including ventricular tachycardia or Torsades de Pointes
- •g.Other clinically significant heart disease (e.g. congestive heart failure, uncontrolled hypertension, history of labile hypertension, or history of poor compliance with an antihypertensive regimen)
- •h.Clinically significant resting bradycardia (less than 50 beats per minute)
- •i.Patients who are currently receiving treatment with any medication which has a relative risk of prolonging the QTcF interval or inducing Torsades de Pointes and cannot be discontinued or switched to an alternative drug prior to commencing start of treatment.
- •j.Obligate use of a cardiac pacemaker
- •6.Patients who have received prior antineoplastic therapy for advanced disease.
- •7.Prior treatment with an Hsp90 inhibitor
- •8.Patients receiving chronic or high dose corticosteroids therapy (Inhaled steroids and short courses of oral steroids for anti-emesis or as an appetite stimulant are allowed)
- •9.Significant infection, including chronic active hepatitis B, hepatitis C, or HIV. Testing for these is not mandatory unless clinically indicated.
- •10.Serious medical or psychiatric conditions that might limit the ability of the patient to comply with the protocol.
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