NL-OMON55657已完成3 期
Randomized open label study to compare the efficacy and safety of everolimus followed by chemotherapy with STZ-5FU upon progression or the reverse sequence, chemotherapy with STZ-5FU followed by everolimus upon progression, in advanced progressive pNETs (SEQTOR study) - Efficacy and safety of everolimus
Grupo Espanol de Tumores Neuroendocrinos (GETNE)0 个研究点目标入组 22 人开始时间: 待定最近更新:
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 22
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
- •1. Adult patients * 18 years old
- •2. Histologically proven diagnosis of unresectable or metastatic, advanced
- •pancreatic NET.
- •3. Documented confirmation of pancreatic NET G1 or G2 as per ENETS
- •classification system:
- •G1: <2 mitoses per 2 mm2 and/or Ki-67 index * 2%
- •G2: 2*20 mitoses per 2 mm2 and/or Ki-67 index >2% and * 20%
- •4. Patients from whom a paraffin-embedded primary tumour or metastasis block is
- •available and to be sent by courier. Patient should give his/her consent for
- •its use in future investigations.
- •5. Before study inclusion, patients must show progressive disease documented by
- •radiology within 12 months prior to study inclusion. If patient received
- •anti-tumour therapy during the past 12 months, he/she must have radiological
- •documentation of progressive disease while on or after receiving that
- •anti-tumour therapy. Treatment naive patients can be also included if, under
- •investigator*s judgement, the patient needs active treatment with either
- •chemotherapy or everolimus.
- •6. Before starting with the second treatment in sequence, patients must show
- •documented disease progression by RECIST 1.0 (local assessment) while on
- •anti-tumour therapy or in case of toxicity caused by the first treatment period.
- •7. ECOG Performance status score 0 - 2.
- •8. Life expectancy > 12 months.
- •9. Presence of measurable disease as per RECIST criteria 1.0, documented by a
- •Triphasic Computed Tomography (CT) scan or multiphase MRI radiological
- •assessment.
- •10. Previous treatment with somatostatin (SS) analogues is allowed. Only those
- •patients with active functioning syndrome at entry can continue with SS
- •analogues during the study.
- •11. Adequate bone marrow function, documented by ANC > 1.5 x 109/L, platelets >
- •100 x 109/L, haemoglobin > 9 g/dL.
- •12. Adequate liver function documented by: serum bilirubin * 2.0 mg/dL, INR *
- •2, ALT and AST * 2.5 x ULN (* 5 x ULN in patients with liver metastasis).
- •13. Adequate renal function documented by: serum creatinine < 1.5 x ULN.
- •14. Fasting serum cholesterol < 300 mg/dL or < 7.75 mmol/L and fasting
- •triglycerides < 2.5 x ULN. If one or both thresholds are exceeded, the patient
- •may only be included after starting treatment with an adequate lipid-lowering
- •15. Women with child-bearing potential must have a negative serum pregnancy
- •test within 14 days prior to enrollment and/or a urine pregnancy test 48 hours
- •before the administration of the first study treatment.
- •16. Written Informed Consent obtained according to local regulations.
排除标准
- •1. Patients with poorly differentiated pancreatic neuroendocrine tumor; this
- •is, pNET G3 as per ENETS classification system: G3: 21 or more mitoses per 2
- •mm2 and/or Ki-67 index >20%
- •2. Previous treatment with chemotherapy and/or mTOR inhibitors (sirolimus,
- •temsirolimus, everolimus, deforolimus) or tirosyne kinase inhibitors
- •(sunitinib, sorafenib, axitinib, pazopanib, regerafenib).
- •3. Immune therapy or radiation therapy within 4 weeks prior to the patient
- •entering the study.
- •4. Hepatic artery embolization within the last 6 months (1 month if there are
- •other sites of measurable disease), or cryoablation/radiofrequency ablation of
- •hepatic metastasis within 2 months of enrolment.
- •5. Previous treatment with Peptide-Receptor Radionuclide Therapy (PRRT) within
- •the last 6 months and/or without progression following PRRT.
- •6. Uncontrolled diabetes mellitus defined as: fasting serum glucose > 1.5 x ULN.
- •7. Patients with any severe and/or uncontrolled medical conditions such as:
- •a. unstable angina pectoris, symptomatic congestive heart failure, myocardial
- •infarction * 6 months prior to randomization, serious uncontrolled cardiac
- •arrhythmia,
- •b. active or uncontrolled severe infection,
- •c. severe hepatic impairment (Child Pugh C) is not allowed; moderate hepatic
- •impairment (Child Pugh B and A) requires a reduced dose of everolimus (5mg and
- •7.5 mg daily respectively). Positive HBV-DNA and or HBsAg patients at screening
- •should receive prophylaxis treatment.
- •d. severely impaired lung function (spirometry and DLCO 50% or less of normal
- •and O2 saturation 88% or less at rest on room air),
- •e. active, bleeding diathesis
- •8. Treatment with potent inhibitors or inducers of CYP3A isoenzyme (rifabutin,
- •rifampicin, clarithromycin, ketoconazole, itraconazole, voriconazole,
- •ritonavir, telithromycin) within 5 days immediately before the start of
- •treatment (a list of clinically significant drug interactions is shown in
- •section 6. Concomitant Medication).
- •9. Patients on chronic treatment with corticosteroids or any other
- •immunosuppressive agent.
- •10. Patients known to be HIV seropositive.
- •11. Known intolerance or hypersensitivity to everolimus or its excipients or
- •other rapamycin analogues. Patients with rare hereditary problems of galactose
- •intolerance, Lapp lactase deficiency or glucose-galactose malabsorption should
- •not take this medicinal product.
- •12. Known intolerance or hypersensitivity to 5FU or STZ or its excipients
- •(notice that this
- •criterion includes patients with known deficit of dihydropyrimidine
- •dehydrogenase
- •deficiency *DPD-).
- •13. Participation in any other clinical trial or concomitant treatment with any
- •other investigational drug.
- •14. No other prior or concurrent malignancy is allowed except for the
- •following: adequately treated basal cell or squamous cell skin cancer, or other
- •adequately treated in situ cancer, or any other cancer from which the patient
- •has been disease free for * 3 years.
- •15. Pregnant, lactating women or fertile adults not using effective birth
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研究者
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