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.
Conditions
Interventions
Intervention1: ?Somatuline Depot / Lanreotide Autogel: 120 mg: During the double-blind phase of the study, patients will be randomized in a 1:1 ratio to one of the treatments administered as a deep
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Sponsors
Ipsen Pharma SAS
Eligibility
Inclusion criteria
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
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 ¡©Basocellular carcinoma of the skin,In situ carcinoma of the cervix,¡Ã 5 years disease free after curative cancer treatment. 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).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Usage 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. | — |
Secondary
| Measure | Time frame |
|---|---|
| Absolute changes from baseline in biochemical marker - plasma Chromogranin A (CgA) during the 16-week double-blind phase of the study.Timepoint: changes from baseline in biochemical marker,during the 16-week.;Absolute changes from baseline in biochemical marker - urinary 5 hydroxyindoleacetic acid (5-HIAA) during the 16-week double-blind phase of the study.Timepoint: changes from baseline in biochemical(5-HIAA) during the 16-week.;Changes from baseline in Quality of Life (QoL) during the 16-week double blind phase of the study; assessed using the European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire C30 Carcinoid/NETs module: EORTC QLQ-G.I. NET 21.Timepoint: Changes from baseline.;Frequency of flushing events (per day) during the 16-week double-blind phase of the study based on patient IVRS diary recordsTimepoint: events (per day).;Proportion of patients who roll over into the open-label phase before completing the double-blind phase of the studyTimepoint: Number of patients who roll over into the open-label phase.;The secondary endpoints are: 1.Frequency of diarrhea events (per day) during the 16-week double-blind phase of the study based on patient IVRS diary records Timepoint: events (per day).;Usage of other rescue medications for diarrhea and/or flushing events (e.g., loperamide 2 mg tabs and/or tincture of opium), measured as the percentage of days that the medications were used as rescue medication during the 16 week double-blind phase of the study based on patient IVRS diary recordsTimepoint: percentage of days that the medications were used as rescue medication | — |
Countries
Brazil, Croatia, Czech Republic, India, Israel, Latvia, Poland, Russian Federation, Serbia, South Africa, Turkey, Ukraine, United States of America
Contacts
Public ContactAbhishek Kumar Srivastava
Omnicare Clinical Reserach India Ltd.
Outcome results
None listed