NL-OMON54089招募中不适用
Improving peptide receptor radionuclide therapy with poly ADP ribose polymerase inhibitor. - The PRRT-PARPi study
Moleculaire geneeskunde0 个研究点目标入组 24 人开始时间: 待定最近更新:
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
- 年龄范围
- 18 至 99（—）
入选标准
- •- Histologically proven locally advanced or metastatic, well-differentiated
- •(grade 1, 2 or 3) 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
- •- The patient is eligible for two cycles of salvage PRRT
- •- 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
- •A potential subject who meets any of the following criteria will be excluded
- •from participation in this study:
- •- 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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