Efficacy and Safety of Lanreotide Autogel/ Depot 120 mg vs. Placebo in Subjects With Lung Neuroendocrine Tumors (SPINET)

Phase 1

Conditions: ung Neuroendocrine Tumours
MedDRA version: 20.0Level: PTClassification code 10078174Term: Neuroendocrine tumour of the lungSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]

Registration Number: EUCTR2015-004992-62-DK

Lead Sponsor: Ipsen Biopharmaceuticals, Inc

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 77

Inclusion Criteria

(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

Exclusion Criteria

(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 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 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 >2xN,
(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 study.

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

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