Phase I Study of Idronoxil Combined With Radiation Treatment in Men With Metastatic Prostate Cancer
试验速览
- 阶段
- 1 期
- 状态
- 终止
- 入组人数
- 1
- 试验地点
- 1
- 主要终点
- safety of Idronoxil dose escalation
研究概览
简要总结
The aim of the study is to determine the toxicity of Idronoxil (NOX66) when used in combination with palliative radiotherapy for metastatic prostate cancer
详细描述
Who is it for? Patient may be eligible for this study if they have late stage metastatic prostate cancer which is castrate resistant and have metastatic lesions that are suitable for radiotherapy.
Study details There are two groups of patients in this study and no randomisation. The two groups will have two different doses of idronoxil (NOX66), representing a 2-step dose escalation. Both groups receive the same standard radiotherapy dose.
Group 1 will receive the lower dose (400 mg) of idronoxil suppository daily and Group 2 800 mg daily.
Recruitment into Group 2 will only commence once all Group 1 patients have completed the 13-day treatment course of idronoxil suppository without excessive unexpected toxicity. The total treatment duration will be 13-15 days for both groups depends on whether radiotherapy is given on consecutive days or over the weekend.
Day 0: commence idronoxil (NOX66) Days 1-5: 1 or 2 lesions will receive 20 Gy (radiotherapy dose unit) radiotherapy in 5 daily fractionated doses and continue daily NOX66 Day 6-12: Continue NOX66 (the duration of NOX66 will be 13-15 days depends on whether radiotherapy is given on consecutive days or over the weekend).
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Sequential
- 主要目的
- Treatment
- 盲法
- None
盲法说明
There is no masking.
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
- •Confirmed metastatic prostate cancer that is castrate-resistant.
- •2-3 lesions suitable for radiotherapy.
- •ECOG Performance status 0-
- •Adequate bone marrow, hepatic and renal function
- •At least 4 weeks must have elapsed prior to commencement of idronoxil treatment since prior chemotherapy, investigational drug or biologic therapy
排除标准
- •Chemotherapy regimens with delayed toxicity within the last 4 weeks.
- •Any situation where the use of suppository therapy is contra-indicated or impractical(eg. chronic diarrhoea, colostomy, ulcerative colitis).
- •No concurrent systemic chemotherapy or biologic therapy is allowed.
- •Psychiatric disorder or social or geographic situation that would preclude study participation.
- •Patient unable to provide consent
研究组 & 干预措施
Group 1 NOX66 400mg and SBRT
Group 1 patients will receive 400mg of Idronoxil (NOX66) suppository (1 suppository) daily from Day 0 (1 day before radiotherapy) until 7 days after completion of radiotherapy. Stereotactic Body Radiation Therapy will be given on Days1-5 (5 fractions). Total treatment course is 13-15 days, depends on whether radiotherapy is given on consecutive days or over the weekend.
干预措施: idronoxil (NOX66) suppository (Drug)
Group 1 NOX66 400mg and SBRT
Group 1 patients will receive 400mg of Idronoxil (NOX66) suppository (1 suppository) daily from Day 0 (1 day before radiotherapy) until 7 days after completion of radiotherapy. Stereotactic Body Radiation Therapy will be given on Days1-5 (5 fractions). Total treatment course is 13-15 days, depends on whether radiotherapy is given on consecutive days or over the weekend.
干预措施: Stereotactic Body Radiation Therapy (Radiation)
Group 2 NOX66 800mg and SBRT
Group 2 patients will receive 800mg of Idronoxil (NOX66) suppository (2 suppositories) daily from Day 0 (1 day before radiotherapy) until 7 days after completion of radiotherapy. Stereotactic Body Radiation Therapy will be given on Days1-5 (5 fractions). Total treatment course is 13-15 days, depends on whether radiotherapy is given on consecutive days or over the weekend.
干预措施: idronoxil (NOX66) suppository (Drug)
Group 2 NOX66 800mg and SBRT
Group 2 patients will receive 800mg of Idronoxil (NOX66) suppository (2 suppositories) daily from Day 0 (1 day before radiotherapy) until 7 days after completion of radiotherapy. Stereotactic Body Radiation Therapy will be given on Days1-5 (5 fractions). Total treatment course is 13-15 days, depends on whether radiotherapy is given on consecutive days or over the weekend.
干预措施: Stereotactic Body Radiation Therapy (Radiation)
结局指标
主要结局
safety of Idronoxil dose escalation
时间窗: From start of NOX66 with stereotactic radiotherapy up to three months post treatment.
Toxicity and relationship with study drug NOX66 will be assessed using Common Terminology Criteria for Adverse Events (CTCAE) V4.3
次要结局
- evidence of clinical tumour response(3 months post treatment)
研究者
Professor Thomas Eade
Principal Investigator
Royal North Shore Hospital