EUCTR2013-000726-66-DE进行中（未招募）1 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) - SEQTOR
Grupo Español de Tumores Neuroendocrinos (GETNE)0 个研究点目标入组 140 人开始时间: 2014年5月12日最近更新:
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 140
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
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 (Section 7.2.10).
- •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 judgment, 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
- •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 agent.
- •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
- •16. Written Informed Consent obtained according to local regulations.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 90
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 90
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
- •6. Uncontrolled diabetes mellitus defined as: fasting serum glucose > 1.5
- •7. Patients with any severe and/or uncontrolled medical conditions such
- •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 dihydropyrimidine dehydrogenase deficiency)
- •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
- •control methods. If barrier contraceptives are used, these must be
- •continued to be used throughout the trial by both sexes and for up to 8
- •weeks after the end of treatment.
- •16. For administrative matters (insurance) patients = 95 are not
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研究者
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