EUCTR2010-019066-92-LV进行中（未招募）不适用
A double-blind, randomized placebo-controlled clinical trial investigating theefficacy and safety of Somatuline Depot (lanreotide) Injection in the treatment ofcarcinoid 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
- •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
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
- •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).
研究者
相似试验
进行中（未招募）
1 期
This is a research study to see whether Lanreotide Autogel will help control the diarrhea and/or flushing caused by carcinoid syndrome.Carcinoid syndromeMedDRA version: 14.1Level: PTClassification code 10007270Term: Carcinoid syndromeSystem Organ Class: 10014698 - Endocrine disordersEUCTR2010-019066-92-CZIpsen Pharma SAS100
进行中（未招募）
不适用
This is a research study to see whether Lanreotide Autogel will help control the diarrhea and/or flushing caused by carcinoid syndrome.Carcinoid syndromeMedDRA version: 14.0Level: PTClassification code 10007270Term: Carcinoid syndromeSystem Organ Class: 10014698 - Endocrine disordersEUCTR2010-019066-92-PLIpsen Pharma SAS100
进行中（未招募）
1 期
A clinicial trial to investigate te effect of valsartan compared to placebo on acute respiratory failure in hospitalized SARS-CoV-2-infected patientsEUCTR2020-001320-34-NLRadboudumc651
已完成
4 期
A double-blind, placebo-controlled randomized clinical trial with valsartan for PRevention of Acute rEspiraTORy dIstress syndrome in hospitAlized patieNts with SARS-COV-2 Infection DiseaseCOVID-19corona virus infectious disease1004743810024970NL-OMON49095Radboud Universitair Medisch Centrum651
尚未招募
4 期
Adjunctive metformin in youth mood and psychotic syndromesACTRN12619001559101niversity of Sydney266