Study to investigate the combination of Lanreotide Autogel 120mg and Temozolomid in patients with WITH PROGRESSIVE GASTRO-ENTERO-PANCREATIC NEUROENDOCRINE TUMOURS

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 65

Inclusion Criteria

(1)Provision of written informed consent prior to any study related procedures.
(2)Male or female of 18 years of age or older.
(3)Inoperable, Gastro-Entero-Pancreatic-Neuroendocrine Tumour G1 or G2 (Ki67-Index: 0 to =20%) confirmed by pathological/histological assessment.
(Previous data assessed not longer than 24 months ago could be used.)
(4)Progressive disease within 12 months before inclusion (RECIST 1.1: increase of >20% tumour load; by CT or MRI).
(5)Metastatic disease confirmed by CT/MRI.
(6)Measureable disease according to RECIST 1.1.
(7)Functioning or non-functioning NET (G1, G2).
(8)WHO performance status 0-2.
(9)Positive Octreo-Scan (= grade 2 Krenning scale) or positive DOTA-TATE/TOC-PET-CT within 12 months prior to screening.
(10)Absolute neutrophile count (ANC) = 1,5x10E09/l prior to Temozolomide intake, thrombocyte count = 100 x 10 E09/l prior to Temozolomide intake.

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 40
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 25

Exclusion Criteria

(1)Has the diagnosis of Insulinoma
(2)Has a history of hypersensitivity to Lanreotide or Temozolomide or drugs with a similar chemical structure and/or any known contraindications to magnetic resonance imaging (MRI)/computerised tomography (CT).
(3)Was treated with any other IMP within the last 30 days before screening visit.
(4)Is likely to require treatment during the study with drugs that are not permitted by the study protocol.
(5)Is at risk of pregnancy or lactation. Females of childbearing potential must provide a negative pregnancy test at start of study and must be using oral, double barrier or injectable contraception. Non childbearing potential is defined as post-menopausal for at least 2 years, surgical sterilisation or hysterectomy at least three months before the start of the study (according to CPMP/ICH/286/95, modified).
(6)Male patients, who do not agree to use an effective method of contraception if their partner is at risk of becoming pregnant during the course of this study and 6 months after the study drug administration.
(7)Male patients who are planning a sperm donation during the entire study participation and at least six months after the last study drug administration.
(8)Has any mental condition rendering the patient unable to understand the nature, scope and possible consequences of the study, and/or evidence of an uncooperative attitude.
(9)Has abnormal baseline findings, any other medical condition(s) or laboratory findings that, in the opinion of the Investigator, might jeopardise the patient’s safety or decrease the chance of obtaining satisfactory data needed to achieve the objective(s) of the study.
(10)HbA1c > 8,5% (centrally assessed during the screening period).
(11)Has had major surgery related to the studied disease within 3 months prior to screening visit.
(12)Has a diagnosis of a multiple endocrine neoplasia (MEN).
(13)Has received Sunitinib, Everolimus within the last 4 weeks prior to screening visit.
(14)Has received PRRT (Peptide Radio-Receptor-Therapy) within 3 months prior to screening visit.
(15)Has received prior chemotherapy regimens within 4 weeks prior to screening visit.
(16)Has received any Temozolomide treatment prior to screening visit.
(17)Has undergone radiation of target lesions within 12 months prior to screening visit.
(18)Has received Interferon-a treatment within 4 weeks prior to screening visit.
(19)Has received local ablative therapies (TACE, SIRT, RFA) within 6 months prior to screening visit.
(20)Has had a previous cancer (except basocellular carcinoma of the skin and/or in situ carcinoma of the cervix/uterus and/or patients treated with curative intent and free from disease for more than 5 years) other than study indication.
(21)Has a history of, or known current, problems with alcohol or drug abuse.
(22)Is deprived of his/her freedom or rights by virtue of an order issued either by any judicial or administrative authorities, is unable to express his/her consent, or is committed to a social or health institution for reasons other than the study.
(23)Has been previously enrolled in this study.
(24)Participation in other trials for the duration of this trial.
(25)Hypersensitivity to dacarbazine (DTIC).