CTRI/2011/04/001690已完成3 期
A double blind, randomized, placebo controlled clinical trial investigating the efficacy and safety of Somatuline Depot (Lanreotide) Injection in the treatment of carcinoid syndrome. - Nil
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 100
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
入选标准
- •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).
排除标准
- •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).
研究者
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