A double-blind, randomized placebo-controlled clinical trial investigating theefficacy and safety of Somatuline Depot (lanreotide) Injection in the treatment ofcarcinoid syndrome - NA

• Conditions: carcinoid syndrome; MedDRA version: 12.1Level: LLTClassification code 10007270Term: Carcinoid syndrome

• Registration Number: EUCTR2010-019066-92-LV
• Lead Sponsor: Ipsen Pharma SAS

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2010-08-18
• Last Update Posted: 14 March 2016

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

1. Male or female at least 18 years of age at the time of first dosing
2. Patients must give signed informed consent before any study-related activities
are conducted.
3. Patients in the United States must have given written authorization for the
release of protected health information in compliance with Health Insurance
Portability and Accountability Act (HIPAA) regulations; patients in other countries
must provide appropriate authorization as needed by regulatory authorities in
each country
4. Patients must be willing to receive subcutaneous octreotide injections as rescue
medication, as needed to control their symptoms, if any.
5. If female, the patient must not be pregnant (confirmed by negative pregnancy
test) and must have the following documented via verbally given history:
- At least 1 year postmenopausal (natural cessation of menses), or
- Surgically sterile (if by tubal ligation, surgery must have been performed more
than 3 months prior to study entry at Screening Visit), or
- If the patient is of childbearing potential and sexually active, she must be using
an acceptable form of contraception (oral, injected, transdermal or implanted
contraceptives, diaphragm or barrier method with spermicidal and/or intrauterine
device); local methods such as condoms or sponges/vaginal tablets are not
acceptable forms of contraception.
6. Patients with a histopathologically confirmed diagnosis of carcinoid tumor or, a
carcinoid tumor of unknown location with liver metastases (documented biopsy),
and a history of carcinoid syndrome (flushing and/or diarrhea) that are either
naïve to treatment with an SSTa or responsive (according to the opinion of the
Principal Investigator) to conventional doses of LAR (= 30 mg every 4 weeks) or to
daily doses of = 600 µg of subcutaneous octreotide.
7. Confirmation of positive somatostatin receptor status by SRS (up to 6 months
prior to study entry at Screening Visit)
8. Absence of tumor progression documented by two sequential CAT scans or two
sequential MRIs (= 3 months apart); the last scan/MRI must have been performed
within 6 months of study entry (Screening Visit).
9. Patients previously treated with LAR must have received their last dose of LAR at
least 4 weeks prior to first dose of study drug (no later than at the Screening
Visit).
10. Be able to communicate and cooperate with the Principal Investigator and the
staff and willing to comply with the study instructions
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

1. Patient has a history of known allergy or hypersensitivity to:
- Investigational drug or any components of its formulation
- Octreotide
2. History of carcinoid syndrome refractory to treatment with conventional doses of
SSTa
3. Treatment with any other investigational drug within 30 days prior to study entry
(Screening Visit) and/or at any time during the patient’s participation in the study
4. Treatment with interferon, chemotherapy and/or radiotherapy, a radiolabelled
SSTa and/or tumor debulking < 3 months prior to study entry (Screening Visit)
5. History of hepatic arterial embolization, hepatic arterial chemoembolization and/or
selective internal radiation therapy (eg. SIR-Spheres) < 6 months prior to study
entry (Screening Visit)
6. Short bowel syndrome
7. Uncontrolled diabetes and/or hypertension
8. Severe renal impairment (glomerular filtration rate < 30 mL/min/1.73m2) and/or
liver impairment (serum total bilirubin > 1.5 mg/dL)
9. Diagnosis of cardiac disease New York Heart Association functional classification
> Class I. (Patient has limitation of physical activity. Ordinary physical activity
causes undue fatigue, palpitation, or dyspnea)
10. Life expectancy less than one year
11. Any malignancies except:
- Carcinoid tumor
- Basocellular carcinoma of the skin
- In situ carcinoma of the cervix
- = 5 years disease free after curative cancer treatment
12. Any serious medical condition that could jeopardize the safety of the patient
and/or the efficacy assessments of the study.
13. Patient is being treated with a Proton Pump Inhibitor (PPI) and has been at a
stable dose (no change in dose or frequency of administration) for less than
4 weeks at study entry (Screening Visit).

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified