EUCTR2010-019066-92-PL进行中（未招募）不适用
A double-blind, randomized placebo-controlled clinical trial investigating the efficacy and safety of Somatuline Depot (lanreotide) Injection in the treatment of carcinoid syndrome - NA
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 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 clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •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 40
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 60
排除标准
- •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 severe liver impairment as evidenced by serum total bilirubin >1.5 mg/dL associated with bile duct blockage or with alkaline phosphatase (AP), aspartate aminotransferase (AST or SGOT) or alanine aminotransferase (ALT or SGPT) >5.0 ULN.
- •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).
研究者
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