NCT04375267已完成1 期
Phase I Trial With 177Lu-DOTA-TATE and Olaparib in Somatostatin Receptor Positive Tumours
Vastra Gotaland Region2 个研究点 分布在 1 个国家目标入组 18 人开始时间: 2020年4月23日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 18
- 试验地点
- 2
- 主要终点
- Number of participants with treatment-related adverse events as assessed by CTCAE v5.0
研究概览
简要总结
This is a phase I study of 177Lu-DOTA-TATE in combination with the PARP-inhibitor olaparib for treatment of patients with somatostatin receptor positive tumours detected by 68Ga-DOTA-TATE/TOC PET. The combination of a PARP inhibitor that will specifically target the repair mechanism, with ionising radiation causing SSB's might overcome the repair dependent survival of the tumour cells, making them more sensitive to β-emission and increase the probability of tumour cell death.
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
- All
- 接受健康志愿者
- 否
入选标准
- •Histological or cytological diagnosis of neoplasia (not mandatory for meningioma)
- •GEPNETs grade 3 or aggressive grade 2 tumours with a poor prognosis and a Ki67 > 15% OR neuroendocrine tumours NOS after standard therapy OR thymomas/tumours of other origin after standard therapy OR meningiomas after standard therapy not suitable for surgery or radiotherapy
- •Evidence of regional or distant metastases or localised disease not accessible for complete resection
- •Measurable disease according to RECIST 1.1
- •Evidence of somatostatin receptor positive disease detected by 68Ga-DOTA-TATE/TOC PET
- •Progressive disease during the last 14 months based on CT or new lesions detected by 68Ga-DOTA-TATE PET.
- •Performance status ECOG 0 - 1
- •Life expectancy > 6 months
- •Age >18 years, no upper age limit.
- •Neutrophil count >1,5 x 109/L
- •Platelet count >100 x 109/L
- •Normal liver function regarding transaminases, PK and albumin. A raised bilirubin which can be considered an isolated effect of liver metastases is not a contraindication as long as the levels remain <1.5 x ULN.
- •GFR > 50 ml/min
- •Written informed consent from patients
- •Evidence of post-menopausal status or negative urinary or serum pregnancy test for female pre-menopausal subjects. Women will be considered post-menopausal if they have been amenorrheic for 12 months without an alternative medical cause. The following age-specific requirements apply:
- •Women <50 years of age would be considered post-menopausal if they have been amenorrheic for 12 months or more following cessation of exogenous hormonal treatments and if they have luteinizing hormone and follicle-stimulating hormone levels in the post-menopausal range for the institution or underwent surgical sterilization (bilateral oophorectomy or hysterectomy).
- •Women ≥50 years of age would be considered post-menopausal if they have been amenorrheic for 12 months or more following cessation of all exogenous hormonal treatments, had radiation-induced menopause with last menses >1 year ago, had chemotherapy-induced menopause with last menses >1 year ago, or underwent surgical sterilization (bilateral oophorectomy, bilateral salpingectomy or hysterectomy).
排除标准
- •Performance Status ECOG > 1
- •Well differentiated GEPNETs grad 1 and 2 (except aggressive grade 2 tumours with a poor prognosis and a Ki67 > 15%)
- •Loco-regional treatment during the last 3 months involving all of the measurable lesions
- •Chemotherapy during the last 8 weeks or longer until no persisting toxicity exists. Earlier treatment with mTORi or TKI the last 4 weeks or until no persisting toxicity exists
- •Previous treatment with 177Lu-DOTA-TATE or cis-/carboplatin
- •Other concomitant nephrotoxic treatment
- •Serious heart disease (NYHA III-IV)
- •Previous radiotherapy including >25% of active bone marrow volume
- •Pregnancy and lactation
- •Extensive liver metastases combined with impaired liver function (i.e. abnormal laboratory parameters (> grad 1 CTCAE) or ascites)
- •Symptomatic CNS metastases (e.g. requiring corticosteroid treatment) Symptomatic treatment for meningiomas or corticosteroids due to treatment related swelling is however allowed
- •Ongoing treatment with interferon. This treatment should be suspended a minimum of 4 wees before treatment with 177Lu-DOTA-TATE, or longer if there is persisting signs of toxicity
- •Patients who have a another metastatic tumor diagnosis
- •Known or expected hypersensitivity to 177Lu-DOTA-TATE, 68Ga- DOTA-TATE/TOC or any of their excipients
- •History of psychiatric disease/condition that may interfere with the objectives and assessments of the study
- •Female subjects who are pregnant or breastfeeding or subjects of reproductive potential who are not willing to employ effective birth control methods (Pearl index <1) from screening to 6 months after the last dose of olaparib
研究组 & 干预措施
177Lu-DOTA-TATE and olaparib
Experimental
干预措施: 177Lu-DOTA-TATE + olaparib (Drug)
结局指标
主要结局
Number of participants with treatment-related adverse events as assessed by CTCAE v5.0
时间窗: up to 6 months after last treatment cycle
To assess the number of participants with toxicity of 177Lu-DOTA-TATE in combination with olaparib measured by NCI Common Toxicity Criteria v 5.0
次要结局
- TTP(3 years)
- Response rate(12 months after last treatment cycle)
- OS(3 years)
- DOR(3 years)
研究者
研究点 (2)
Loading locations...
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