EUCTR2015-004992-62-PL进行中（未招募）1 期
A PHASE 3, PROSPECTIVE, RANDOMIZED, DOUBLE-BLIND, MULTI-CENTER, STUDY OF THE EFFICACY AND SAFETY OF LANREOTIDE AUTOGEL/ DEPOT 120 MG PLUS BSC VS. PLACEBO PLUS BSC FOR TUMOR CONTROL IN SUBJECTS WITH WELL DIFFERENTIATED, METASTATIC AND/OR UNRESECTABLE TYPICAL OR ATYPICAL LUNG NEUROENDOCRINE TUMORS - SPINET
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 216
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) Provision of written informed consent prior to any study related
- •procedures,
- •(2) Subjects aged = 18 years, (3) Have metastatic and/or unresectable
- •pathologically confirmed well-differentiated, typical or atypical
- •neuroendocrine tumour of the lung,
- •(4) Histologic evidence of well differentiated NETs of the lung (typical
- •and atypical according to the WHO criteria evaluated locally),
- •(5) Has a mitotic index <2 mitoses/2 mm2 for typical carcinoid (TC) and
- •<10 mitoses/2 mm2 and/or foci of necrosis for atypical carcinoid (AC),
- •(6) At least one measurable lesion of the disease on imaging (CT or MRI;
- •RECIST v1.1)),
- •(7) Positive somatostatin receptor imaging (SRI) (Octreoscan® = grade
- •2 Krenning scale; Ga-PET scan: uptake greater than liver background);),
- •(8) ECOG performance status 0-1,
- •(9) Female subject of childbearing potential should have a negative
- •urine or serum pregnancy test within 72 hours prior to randomization. If
- •the urine test is positive or cannot be confirmed as negative, a serum
- •pregnancy test will be required.,
- •(10) Female subjects who are at risk of becoming pregnant must agree
- •to use an effective method of contraception such as double barrier
- •contraception, an injectable, combined oral contraceptive or an intrauterine
- •device (IUD). The subject must agree to use the contraception
- •during the whole period of the study and for eight months after the last
- •study drug administration. Non childbearing potential is defined as being
- •postmenopausal for at least 1 year, or permanently sterilized at least 3
- •months before study entry, (11) Male subjects must agree that, if their
- •partner is at risk of becoming pregnant, they will use an effective
- •method of contraception (see above),). The subject must agree to use
- •the contraception during the whole period of the study and for eight
- •months after the last study drug administration,
- •(12) Signed HIPAA authorization where required,
- •(13) Subjects must be willing and able to comply with study restrictions
- •and to remain at the clinic for the required duration during the study
- •period and willing to return to the study site for the follow-up evaluation
- •as specified in the protocol.
- •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 166
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 50
排除标准
- •(1) Poorly differentiated or high grade carcinoma, or subjects with
- •neuroendocrine tumours not of lung origin are excluded,
- •(2) Subjects with Multiple endocrine neoplasia type 1 (MEN 1),
- •(3) Has been treated with an SSA at any time prior to randomization,
- •except if that treatment was for less than 15 days (e.g. peri-operatively)
- •of short acting SSA or one dose of long acting SSA and the treatment
- •was received more than 6 weeks prior to randomization,
- •(4) Has been treated with Peptide receptor radionuclide therapy (PRRT)
- •at any time prior to randomization,
- •(5) Has been treated for Lung NET with chemotherapy* within 4 weeks
- •of randomization (whatever the number of cycles),
- •(6) Has been treated with more than two lines of chemotherapy* for
- •* cytotoxic chemotherapy or molecular targeted therapy or interferon.
- •(7) Treated with surgery within 6 weeks prior to randomization,
- •(8) Previous local therapy (e.g. chemo-embolization, bland, or radioembolization)
- •is allowed if completed > 6 weeks prior to randomization.
- •For subjects who received local therapy prior to randomization, there
- •must be documented growth of measurable disease within the
- •embolization field prior to study,
- •(9) Symptomatic subjects requiring SSA for symptom management
- •(please also note the exclusion criteria 3),
- •(10) Subjects with known ectopic production of adrenocorticotropic
- •hormone (ACTH) or other hormonal secreting subjects allowed – ONLY if symptoms adequately controlled without SSAs,
- •(11) Subjects on concomitant Growth Hormone (GH) antagonist,
- •cyclosporine or bromocriptine
- •(12) Inadequate bone marrow function as per investigator's judgement
- •(13) Severe renal insufficiency as defined by a calculated creatinine
- •clearance <30 mL/min,
- •(14) Total bilirubin >2x ULN, AST, ALT or Alk Ph >5xN, lipase, amylase
- •(15) Serum albumin <3.0 g/dL unless prothrombin time is within the
- •normal range,
- •(16) Known hypersensitivity to the study drug,
- •(17) Present cholecystitis,
- •(18) Uncontrolled congestive heart failure
- •(19) Glycosylated hemoglobin (HbA1c) > 8.5%,
- •(20) Abnormal findings, any other medical condition(s) or laboratory
- •findings that, in the opinion of the investigator, would compromise the
- •subject's safety or the outcome of the study,
- •(21) 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,
- •(22) Pregnant or lactating women or those of childbearing potential age
- •and not practicing a medically acceptable method for birth control,
- •(23) Subjects who have participated in any therapeutic clinical
- •study/received any investigational agent within 30 days of
- •randomization.
- •(24) Clinically significant cardiac arrhythmia, bradycardia, tachycardia
- •that would compromise patient safety or the outcome of the study
- •(25) Uncontrolled hypothyroidism
- •(26) Has been previously screened (i.e. informed consent signed) in this
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