ACTRN12618000309280终止1 期
Peptide Receptor Radionuclide Therapy administered to Participants withMeningioma with 67Cu-SARTATE™: A single-centre, open-label, nonrandomised,Phase I-IIa Theranostic Clinical Trial
适应症
试验速览
- 阶段
- 1 期
- 状态
- 终止
- 入组人数
- 5
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
- Non-randomised trial
- 主要目的
- Treatment
- 盲法
- Open (masking not used)
入排标准
- 年龄范围
- 50 Years 至 o limit（—）
- 性别
- All
入选标准
- •1. Signed informed consent.
- •2. Age greater than or equal to 50 years.
- •3. Life expectancy greater than or equal to 3 months.
- •4. Has adequate organ function as defined by the following laboratory values obtained within 28 days prior to administration of 64CuSARTATE:
- •a. Estimated glomerular filtration rate (eGFR) greater than 40ml/min as measured using Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) equation.
- •b. Aspartate aminotransferase (AST) and alanine aminotransferase
- •(ALT) less than 3.0 x upper limit of normal (ULN).
- •c. QT interval less than /=450msec as measured by 12 lead ECG.
- •5. Eastern Cooperative Oncology Group (ECOG) performance score of less than or equal to 2.
- •6. Diagnosis of recurrent or progressive histologically confirmed WHO grade I-III meningioma which has failed standard of care therapies. Patients will be considered to have failed standard care when they have disease that is progressing despite standard treatment (primarily radiotherapy) or where, in the opinion of their treating physician, further standard therapy is considered to be of sufficiently high risk of complication as to warrant consideration of alternate therapies.
- •7. Male participants must agree to use contraception methods from Day 0 through to 4 weeks after the last dose of 67Cu-SARTATE.
- •8. A female participant is eligible to participate if she is of:
- •a. Non-childbearing potential defined as pre-menopausal females with a documented tubal ligation or hysterectomy; or postmenopausal defined as 12 months of spontaneous amenorrhea [in questionable cases a blood sample with simultaneous follicle stimulating hormone (FSH) greater than 40 MlU/ml and oestradiol less than 40 pg/ml (less than 140 pmol/l) is confirmatory].
- •b. Child-bearing potential and agrees to use contraception methods for an appropriate period of time (as determined by the Investigator) prior to Day 0 to sufficiently minimize the risk of pregnant females being enrolled. These measures are the combination of a barrier method AND established (greater than 2 cycles) hormonal methods (e.g. the oral contraceptive pill). Absolute sexual abstinence may be considered acceptable at the discretion of the investigator. Abstinence for the 12 days prior to therapy to allow for serum B-hCG assessment which should then ensure the patient is not pregnant prior to therapy administration.
- •c. Female participants must agree to use contraception until four weeks after the last dose of 67Cu-SARTATE.
- •To be eligible for 67Cu-SARTATE administration:
- •9. 64Cu-SARTATE uptake in tumour higher than that of liver at 24 hrs.
排除标准
- •1. Known sensitivity or allergy to somatostatin analogues.
- •2. Participants who have received interventional treatment for their meningioma within the four weeks prior to Day 0.
- •3. Any major surgery within the four weeks prior to Day 0.
- •4. Any additional planned interventions, including surgery or radiation therapy that would interfere with safety or efficacy assessments.
- •5. Treatment with long acting somatostatin analogues within 28 days prior to Day 0. Treatment with short acting somatostatin analogues within 24hrs prior to Day 0.
- •6. Any other malignancy in the past 5 years except for CIN of the cervix, squamous cell carcinoma (SCC) of the skin, basal cell carcinoma (BCC) of the skin or clinical insignificant prostate cancer not requiring prior therapy.
- •7. Breastfeeding females and pregnant females.
- •8. Treatment with any investigational agent received within four weeks prior to Day 0.
- •9. Participants unwilling or unable to comply with protocol requirements.
- •10. Urinary or faecal incontinence of sufficient degree to be of concern for contamination risk in the opinion of the Investigator.
研究者
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