Windows Trial of INsulin-like Growth Factor Neutralising Antibody Xentuzumab in MEN Scheduled for Radical Prostatectomy (WINGMEN)
试验速览
- 阶段
- 早期 1 期
- 状态
- 已完成
- 入组人数
- 27
- 试验地点
- 1
- 主要终点
- Percentage Change of Phospho-IGF-1R Positive Tumour Cells Following Treatment With Xentuzumab
研究概览
简要总结
The WINGMEN trial aims to understand how a hormone-like protein called insulin-like growth factor (IGF) helps prostate cancers grow and become aggressive. IGF is required for normal development, and also helps cancers grow and spread. Men with high blood IGF are at increased risk of developing prostate cancer, and tall men are more likely to get aggressive prostate cancer. The WINGMEN trial will recruit 30 men with prostate cancer who have been offered an operation to remove the prostate. Most men have to wait 4-5 weeks between a decision to have prostate removal surgery, and actually having the operation. In this 4-5 week window we will offer treatment with a new IGF-blocker drug called xentuzumab. The drug is provided by Boehringer Ingelheim and the trial is funded by Prostate Cancer UK.
Xentuzumab will be given as an outpatient by once weekly intravenous infusion (drip) in the Early Phase Clinical Trials Unit, Oxford Cancer Centre, Churchill Hospital. In other trials, xentuzumab is being tested in patients with advanced cancer, and is proving to be well-tolerated. After the 4-week treatment, WINGMEN trial patients will have routine prostate removal surgery. Samples of blood and prostate cancer that are surplus to diagnostic need will be taken from the diagnostic prostate biopsy (pre-xentuzumab) and the cancer removed at surgery (after xentuzumab) for research tests. These samples will be compared to measure how effectively xentuzumab reduces signs of tumour growth, and identify which genes and proteins are switched on or off by xentuzumab, and which may therefore be important in helping IGF promote prostate cancer growth. The information we get from the WINGMEN trial may help us to improve treatment of men with prostate cancer, with the long-term aim of reducing the risk of aggressive prostate cancer
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •A patient will be eligible for inclusion in this study if all of the following criteria apply.
- •Men with prostate adenocarcinoma confirmed on prostate biopsy and with sufficient cancer-containing biopsy tissue surplus to diagnostic need to provide 2 sections for primary endpoint analysis.
- •Scheduled for open or robotic radical prostatectomy
- •Age ≥ 18 years
- •Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1 (Appendix 1)
- •The patient is willing and able to comply with the protocol scheduled follow-up visits and examinations for the duration of the study
- •Participant is willing and able to give informed consent.
- •Participants whose partner is of child bearing potential must be willing to ensure that they or their partner use effective contraception during the trial and for 70 days thereafter.
- •Adequate hematologic, renal and hepatic function, defined as follows:
- •Laboratory Test Value required Hemoglobin (Hb) ≥90g/L White Blood Count (WBC) >2.5 x 10*9/L Absolute Neutrophil Count (ANC) ≥ 1.5 x10*9/L Platelet count ≥ 100 x 10*9/L AST, ALT, and alkaline phosphatase ≤ 2.5 x upper limit of normal eGFR* ≥30ml/min
- •*eGFR calculated by Cockcroft & Gault formula,
排除标准
- •A patient will not be eligible for the trial if any of the following apply:
- •Treated with systemic corticosteroids, insulin, metformin, other oral hypoglycemic agent, or anti-androgens in the 28 days prior to first dose of study drug
- •Diabetes mellitus
- •Previous prostate radiotherapy
- •Current or previous treatment with xentuzumab or other IGF or GH -modifying therapy
- •Patients who are known to be serologically positive for Hepatitis B, Hepatitis C or HIV
- •Treatment with any other investigational agent, or treatment in another interventional clinical trial within 28 days prior to enrolment
- •Other psychological, social or medical condition, physical examination finding or a laboratory abnormality that the Investigator considers would make the patient a poor trial candidate or could interfere with protocol compliance or the interpretation of trial results
研究组 & 干预措施
Xentuzumab
All patients will be allocated to receive Xentuzumab
干预措施: Xentuzumab (Drug)
结局指标
主要结局
Percentage Change of Phospho-IGF-1R Positive Tumour Cells Following Treatment With Xentuzumab
时间窗: From first xentuzumab infusion at week 1 (pre-treatment) to surgery at week 4-13 (post-treatment). Up to 13 weeks total.
Diagnostic biopsies (pre-treatment) and in-theatre cores (post-treatment) were stained with phospho-IGF-1R. Percentage of positively stained tumour cells in each sample were compared and the percentage change between timepoints was quantified. A negative percentage change indicates a reduction in phospho-IGF-1R in post-treatment samples. This endpoint was designed to assess the amount of IGF pathway inhibition induced by xentuzumab.
Percentage Change of Phospho-S6 Positive Tumour Cells Following Treatment With Xentuzumab
时间窗: From first xentuzumab infusion at week 1 (pre-treatment) to surgery at week 4-13 (post-treatment). Up to 13 weeks total.
Diagnostic biopsies (pre-treatment) and in-theatre cores (post-treatment) were stained by phospho-S6. Percentage of positively stained tumour cells in each sample were compared and the percentage change between timepoints was quantified. A negative percentage change indicates a reduction in phospho-S6 in post-treatment samples. This endpoint was designed to assess the amount of IGF pathway inhibition induced by xentuzumab.
次要结局
- Number of Participants Who Had at Least 4 Doses of Xentuzumab and Proceeded to Have Surgery Per the Protocol Schedule(From first xentuzumab infusion at week 1 (pre-treatment) to surgery at week 4-13 (post-treatment). Up to 13 weeks total.)
- Median Delay in Surgery in Participants Who Had More Than 4 Doses of Xentuzumab (and Whose Surgery Was Delayed by Factors Other Than Trial Treatment)(From first xentuzumab infusion at week 1 (pre-treatment) to surgery at week 4-13 (post-treatment). Up to 13 weeks total.)
- Number of Patients Experiencing an Adverse Event (AE) or Serious Adverse Event (SAE) While On-trial(From consent at week -1 to the end of study visit at up to 19 weeks)
- Number of Patients With Any Adverse Event Assessed as Treatment-Related (TRAE) While On-trial(From consent at week -1 to the end of study visit at up to 19 weeks)