Treatment of clinical symptoms of carcinoid syndrome.
Conditions
Interventions
Trade Name: Somatuline Autogel 90mg
Product Name: Somatuline Autogel
Pharmaceutical Form: Solution for injection
INN or Proposed INN: Lanreotide acetate
CAS Number: 127984-74-1
Concentration unit: mg
Sponsors
Beaufour Ipsen Pharma
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: At the screening visit patients MUST satisfy all of the following criteria before they will be allowed to participate in the study: a) Male or female of 18 years of age or older. b) Histologically confirmed diagnosis of a neuroendocrine tumour of the carcinoid type c) Documented evidence of carcinoid syndrome (flushing and/or diarrhoea) attributable to a primary tumour of the lung, stomach or mid-gut d) Previous positive Octreoscan. e) World Health Organisation (WHO) performance score lower than 2 (Appendix 2 of protocol). f) Written informed consent given. At the baseline visit patients MUST satisfy the following criteria before they are randomised to receive study treatment: g) Stool and/or flushing frequency of =3 episodes/day (average over a minimum five consecutive days). h) Patients who have previously been treated with somatostatin analogues must have discontinued treatment for a sufficient period of time (a washout period of at least 7 days for immediate release formulations and up to 2 months for prolonged release formulations is usually required). Compared with their "controlled" state on treatment, these patients must show a clinically significant deterioration (at least two episodes) of either symptom. For example, a patient considered to be controlled on their previous treatment with an estimated stool frequency of two episodes per day, must achieve a stool frequency of at least four episodes per day (average over a minimum five consecutive days). i) WHO performance score lower than 2 (Appendix 2 of 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 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: If any of the following criteria apply the patient must not enter/continue in the study: a) VIPoma or other non-carcinoid tumour. b) Treatment with interferon, chemotherapy or radiotherapy given within 30 days prior to inclusion, or planned during the study. c) Radionuclide treatment within three months prior to inclusion, or planned during the study. d) Presence of other active malignant pathology (except basal cellular carcinoma of the skin and/or in situ carcinoma of the cervix/uterus). e) Surgical procedure or embolisation procedure (with or without cytotoxic agents) of the tumour within three months prior to inclusion, or planned during the study. f) Patient is pregnant, lactating, or not taking adequate precautions against pregnancy. (NB Patients of childbearing potential must demonstrate a negative serum pregnancy test, and be using appropriate double methods of contraception, such as approved hormonal contraceptives or a condom used with a spermicide). g) Life expectancy of less than 6 months. h) Known hypersensitivity to any of the test materials or related compounds. i) Any investigational drug given within 30 days prior to inclusion or expected to be given during the study. j) Previous participation in this study. k) No access to a telephone for completion of the daily telephone diary. l) In the opinion of the investigator the patient is unable and/or unwilling to comply fully with the protocol and the study instructions.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To evaluate the efficacy of lanreotide Autogel (90 and 120 mg), compared with Sandostatin LAR Depot (20 and 30 mg), in terms of the frequency of target symptom episodes, assessed by the change from baseline in the average daily number of episodes of the target symptom at Week 24.;Secondary Objective: To evaluate the efficacy of lanreotide Autogel (90 and 120 mg), compared with Sandostatin LAR Depot (20 and 30 mg), with regard to: • Change from baseline in daily stool frequency at Week 24. • Change from baseline in daily flushing frequency at Week 24. • Change from baseline in urinary 5-HIAA at Week 24. • Change from baseline in plasma chromogranin A at Week 24. • Use of Sandostatin Injection as rescue medication. • Use of anti-diarrhoeal medication. Other secondary efficacy analyses may include change from baseline in target symptom, daily stool episodes, and daily flushing episodes at Week 4, 8, 12, 16 and 20. To evaluate the safety of lanreotide Autogel (90 and 120 mg) and Sandostatin LAR Depot (20 and 30 mg) over six months, with regard to the following assessments: • Treatment-emergent AEs. • Gallbladder ultrasound (sludge or lithiasis). • Echocardiography. • Local tolerance.;Primary end point(s): Target symptom frequency. | — |
Countries
Finland
Outcome results
None listed