A clinical trial to study the effectiveness and safety of Lanreotide injection in patients with carcinoid syndrome. Carcinoid syndrome is a group of symptoms associated with carcinoid tumors,such as diarrhea and/or flushing.

Phase 3

Completed

• Conditions: Health Condition 1: null- Treatment of carcinoid syndrome. Patients with a histopathologically confirmed diagnosis of carcinoid tumor or, a carcinoid tumor of unknown location with liver metastases.

• Registration Number: CTRI/2011/04/001690
• Lead Sponsor: Ipsen Pharma SAS

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 24 November 2021

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 100

Inclusion Criteria

1. Male or female at least 18 years of age at the time of first dosing

2. Patients must be willing to receive subcutaneous octreotide injections as rescue medication, as needed to control their symptoms, if any.

3. 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.

4. Confirmation of positive somatostatin receptor status by SRS (up to 6 months prior to study entry at Screening Visit)

5. 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).

6. 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).

Exclusion Criteria

1. Patient has a history of known allergy or hypersensitivity to:Investigational drug or any components of its formulationOctreotide.

2. History of carcinoid syndrome refractory to treatment with conventional doses of SSTa.

3. Treatment with interferon, chemotherapy and/or radiotherapy, a radiolabelled SSTa and/or tumor debulking 3 months prior to study entry(Screening Visit.

4. 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).

5. Short bowel syndrome.

6. Uncontrolled diabetes and/or hypertension.

7. Severe renal impairment (glomerular filtration rate 30 mL/min/1.73m2) and/or liver impairment (serum total bilirubin 1.5 mg/dL).

8. 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).

9. Life expectancy less than one year.

10. Any malignancies except:Carcinoid tumor

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11. Any serious medical condition that could jeopardize the safety of the patient and/or the efficacy assessments of the study.

12. 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
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
sage of subcutaneous octreotide required to control symptoms associated with carcinoid syndrome, measured as the percentage of days that subcutaneous octreotide is used as rescue medication during the 16-week double-blind phase of the study.Timepoint: After Baseline.