Efficacy and Safety of Lanreotide Autogel/ Depot 120 mg vs. Placebo in Subjects With Lung Neuroendocrine Tumours (SPINET)
- Conditions
- ung Neuroendocrine TumoursTherapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]MedDRA version: 20.0Level: PTClassification code 10052399Term: Neuroendocrine tumourSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
- Registration Number
- EUCTR2015-004992-62-DE
- Lead Sponsor
- Ipsen Biopharmaceuticals, Inc
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 77
(1) Provision of written informed consent prior to any study related procedures,
(2) Subjects aged = 18 years,
(3) Have metastasic 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 intra-uterine 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 54
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 23
(1) Poorly differentiated or high grade carcinoma, or neuroendocrine tumours not of lung origin,
(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 lung NET,
(* 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 radio-embolization) 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 No. 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 >2 x ULN, AST, ALT or Alk Ph >5xULN, lipase, amylase >2xULN,
(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
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method