NL-OMON55150招募中3 期
A phase III multi-center, randomized, open-label study to evaluate the efficacy and safety of Lutathera in patients with Grade 2 and Grade 3 advanced GEP-NET - NETTER2
Advanced Accelerator Applications Internationals SA0 个研究点目标入组 10 人开始时间: 待定最近更新:
适应症
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 发起方
- 入组人数
- 10
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
- 16 至 99（—）
入选标准
- •Subjects eligible for inclusion in this study must meet all of the following
- •1. Presence of metastasized or locally advanced, inoperable (curative intent)
- •histologically proven, well differentiated Grade 2 or Grade 3
- •gastroenteropancreatic neuroendocrine (GEP-NET) tumor diagnosed within 6 months
- •prior to screening.
- •2. Ki67 index >=10 and <= 55%.
- •3. Patients >=15 years of age and a body weight of >40 kg at screening.
- •4. Expression of somatostatin receptors on all target lesions documented by
- •CT/MRI scans, assessed by any of the following somatostatin receptor imaging
- •(SRI) modalities within 3 months prior to randomization: [68Ga]-DOTA-TOC (e.g.
- •Somakit-TOC®) PET/CT (or MRI when applicable based on target lesions) imaging
- •or [68Ga]-DOTA-TATE PET/CT (or MRI
- •when applicable based on target lesions) imaging (e.g. NETSPOT®) or
- •Somatostatin Receptor scintigraphy (SRS) with 111In-pentetreotide (Octreoscan®
- •SPECT/CT), SRS with [99mTc]-Tektrotyd, [64Cu]-DOTA-TATE PET/CT (or MRI when
- •applicable based on target lesions) imaging.
- •5. The tumor uptake observed in the target lesions must be > normal liver
- •uptake observed on planar imaging.
- •6. Karnofsky Performance Score (KPS) *60.
- •7. Presence of at least 1 measurable site of disease.
- •8. Patients who have provided a signed informed consent form to participate in
- •the study, obtained prior to the start of any protocol related activities.
排除标准
- •Subjects meeting any of the following criteria are not eligible for inclusion
- •in this study.
- •1. Creatinine clearance <40 mL/min calculated by the Cockroft Gault method.
- •2. Hb concentration <5.0 mmol/L (<8.0 g/dL); WBC <2x109/L (2000/mm3); platelets
- •<75x109/L (75x103/mm3).
- •3. Total bilirubin >3 x ULN.
- •4. Serum albumin <3.0 g/dL unless prothrombin time is within the normal range.
- •5. Pregnancy or lactation.
- •6. A Women of child-bearing potential, defined as all women physiologically
- •capable of becoming pregnant, are not allowed to participate in this study
- •UNLESS they are using highly effective methods of contraception throughout the
- •study treatment period (including cross-over and re-treatment, if applicable)
- •and for 6 months after study drug discontinuation. Sexually active male
- •patients, unless they agree to remain abstinent (refrain from heterosexual
- •intercourse) or be willing to use effective methods of contraception with
- •female partners of childbearing potential or pregnant female partners during
- •the treatment period (including cross-over and re-treatment, if applicable) and
- •for 6 months after study drug discontinuation. In addition, male patients must
- •refrain from donating sperm during this same period.
- •7. Peptide receptor radionuclide therapy (PRRT) at any time prior to
- •randomization in the study.
- •8. Documented RECIST progression to previous treatments for the current GEP-NET
- •at any time prior to randomization.
- •9. Patients for whom in the opinion of the investigator other therapeutic
- •options (eg chemo-, targeted therapy) are considered more appropriate than the
- •therapy offered in the study, based on patient and disease characteristics.
- •10. Any previous therapy with Interferons, Everolimus (mTOR-inhibitors),
- •chemotherapy or other systemic therapies of GEP-NET administered for more than
- •1 month and within 12 weeks prior to randomization in the study.
- •11. Any previous radioembolization, chemoembolization and radiofrequency
- •ablation for GEP-NET.
- •12. Any surgery within 12 weeks prior to randomization in the study.
- •13. Known brain metastases, unless these metastases have been treated and
- •stabilized for at least 24 weeks, prior to screening in the study. Patients
- •with a history of brain metastases must have a head CT or MRI with contrast to
- •document stable disease prior to randomization in the study.
- •14. Uncontrolled congestive heart failure (NYHA II, III, IV). Patients with
- •history of congestive heart failure who do not violate this exclusion criterion
- •will undergo an evaluation of their cardiac ejection fraction prior to
- •randomization, via echocardiography. The results from an earlier assessment
- •(not exceeding 30 days prior to randomization) may substitute the evaluation at
- •the discretion of the Investigator, if no clinical worsening is noted. The
- •patient*s measured cardiac ejection fraction in these patients must be >40%
- •before randomization.
- •15. QTcF > 470 msec for females and QTcF > 450 msec for males or congenital
- •long QT syndrome.
- •16. Uncontrolled diabetes mellitus as defined by hemoglobin A1c value > 7.5%.
- •17. Hyperkaleamia >6.0 mmol/L (CTCAE Grade 3) which is not corrected prior to
- •study enrolment.
- •18. Any patient receiving treatment with short-acting octreotide, which cannot
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