NL-OMON21221招募中不适用
Improving Peptide Receptor Radionuclide Therapy with PARP inhibitors.
Erasmus MC, Rotterdam, the Netherland0 个研究点目标入组 24 人开始时间: 待定最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 24
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
入选标准
- •Histologically proven locally advanced or metastatic, well-differentiated NET
- •-Disease progression based on RECIST v1.1 following initial or salvage treatment with PRRT with 177Lu-DOTATATE with a progression free interval of at least 12 months since first cycle of previous administration of PRRT or with no suitable systemic alternative treatment options
- •-Two cycles of PRRT are considered by the treating physician
- •-Measurable disease according to RECIST v1.1 on CT/MRI
- •-Confirmed presence of somatostatin receptors on all target lesions on CT/MRI , based on positive uptake on a 68Ga-DOTATATE/-TOC/-NOC PET-CT/MRI scan
- •-Age = 18 years
- •-Karnofsky Performance Score (KPS) > 60
排除标准
- •-Hb concentration <6.2 mmol/L; white blood cell count <3x109/L; platelets <100x109/L; neutrophil count <1.5x109/L
- •-Renal insufficiency defined as a creatinine clearance <50 mL/min, measured in 24-hour urine collection
- •-Liver function or enzyme abnormalities defined as a total bilirubin >3 x ULN, Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) > 2.5 x ULN or serum albumin <3.0 g/dL unless prothrombin time is within the normal range.
- •-Pregnancy, lactation and inability to comply with effective means of contraception in females of child-bearing age.
- •-Neuroendocrine carcinoma of any origin.
- •-Any surgery, radioembolization, chemoembolization, chemotherapy and radiofrequency ablation within 12 weeks prior to inclusion in the study. Interferons, everolimus, sunitinib or other systemic therapies within 4 weeks prior to inclusion in the study.
- •-Uncontrolled congestive heart failure (NYHA II, III, IV).
- •-Patients with any other significant medical, psychiatric, or surgical condition, currently uncontrolled by treatment, which may interfere with the completion of the study.
- •-Prior external beam radiation therapy to more than 25% of the bone marrow.
- •-Other known co-existing malignancies except non-melanoma skin cancer and carcinoma in situ of the uterine cervix, unless definitively treated and proven no evidence of recurrence for 5 years.
- •-Patients who use a strong CYP3A4 inhibitor within 1 week before start of the treatment or a CYP3A4 inducer within 4 weeks before start of the treatment.
- •-History or evidence of any other clinically significant disorder, condition or disease (with the exception of those outlined above) that, in the opinion of the investigator would pose a risk to subject safety or interfere with the study evaluation, procedures or completion.
- •-Known allergy or intolerance for the (non-)investigational drugs
- •-Inability to provide informed consent
- •-End of life care
研究者
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