EUCTR2012-003460-47-NL进行中（未招募）1 期
A Phase 3, Randomized, Placebo-controlled, Parallel-Group, Multicenter, Double-blind Study to Evaluate the Efficacy and Safety of Telotristat Etiprate (LX1606) in Patients with Carcinoid Syndrome Not Adequately Controlled by Somatostatin Analog (SSA) Therapy - TELESTAR (Telotristat Etiprate for Somatostatin Analogue Refractory Carcinoid Syndrome)
exicon Pharmaceuticals, Inc.0 个研究点目标入组 105 人开始时间: 2013年1月7日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 105
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.Patients =18 years of age at the time of the Screening visit
- •2.Histopathologically-confirmed, well-differentiated metastatic NET with extent documented by computed tomography (CT), magnetic resonance imaging (MRI), or radionuclide imaging
- •3.A documented history of CS, and currently experiencing an average of =4 BM per day during the Run-in Period. Confirmation of eligibility will be determined by measuring the mean number of BM
- •4.Currently receiving a stable-dose SSA therapy. For the purposes of this study, stable-dose SSA therapy is defined as long acting release (LAR) or Depot SSA therapy or a continuous subcutaneous infusion via a pump. Patients must have been receiving the same dose level and frequency for at least 3 months prior to entering the Run-in Period.
- •5.Minimum dose of LAR or Depot SSA therapy (higher dose or more frequent intervals will exceed minimum dose). SSA therapy must be approved for use in CS in the patient’s country of residence or prescribers’ country of practice.
- •a.Octreotide LAR at 30 mg every 4 weeks
- •b.Lanreotide Depot at 120 mg every 4 weeks
- •c.Patients who cannot tolerate SSA therapy at a level indicated above will be allowed to enter at their highest tolerated dose
- •6.Patients of childbearing potential must agree to use an adequate method of contraception (defined as having a failure rate of <1% per year) during the study and for 12 weeks after the Follow-up visit. Adequate methods of contraception for patients or partner include condoms with spermicide gel, diaphragm with spermicide gel, coil (intrauterine device), surgical sterilization, vasectomy, oral contraceptive pill, depot progesterone injections, progesterone implant, and abstinence during the study and for 12 weeks after the Follow-up Visit.
- •a. Childbearing potential is defined as those who have not undergone surgical sterilization, or those who are not considered postmenopausal. Postmenopause is defined as absence of menstruation for at least 2 years. If necessary, follicle-stimulating hormone (FSH) results >50 IU/L at Screening are confirmatory in the absence of a clear postmenopausal history.
- •7.Ability and willingness to provide written informed consent prior to participation in any study-related procedure
- •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 90
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 15
排除标准
- •Patients who meet any of the following criteria will be excluded from participating in the study:
- •1.Presence of diarrhea attributed to any condition(s) other than CS (including, but not limited to fat malabsorption or bile acid malabsorption)
- •2.Presence of more than 12 watery BM per day associated with volume contraction, dehydration, or hypotension compatible with a pancreatic cholera”-type clinical syndrome, as judged by the Investigator
- •3.Positive stool examination for enteric pathogens, pathogenic ova or parasites, or Clostridium difficile at Screening
- •4.Karnofsky Performance Status =60%
- •5.Clinical laboratory values for hematology (at Screening):
- •a.Absolute neutrophil count (ANC) =1500 cells/mm3; or
- •b.Platelets =75,000 cells/mm3; or
- •c.Hemoglobin (Hgb) =9 g/dL for males and =8 g/dL for females
- •6.Hepatic laboratory values (at Screening) such that:
- •a.Aspartate transaminase (AST), or alanine aminotransferase (ALT):
- •=5.5 x upper limit of normal (ULN) if patient has documented history of hepatic metastases; or
- •=2.5 x ULN if patient does not have documented history of hepatic metastases
- •b.Total bilirubin >1.5 x ULN (unless patient has a documented history of Gilbert’s Syndrome); or
- •c.Alkaline phosphatase (ALP) =5 x ULN, if total bilirubin is >ULN
- •No upper limit on the ALP value if the total bilirubin is =ULN
- •7.Serum creatinine =1.5 x ULN
- •8.Treatment with any tumor directed therapy including, but not limited to: interferon, chemotherapy, mTOR inhibitors =4 weeks prior to Screening; or hepatic embolization, radiotherapy, radiolabelled SSA, and/or tumor debulking =12 weeks prior to Screening
- •9.Major surgery defined as procedures requiring general anesthesia or major regional anesthesia within 8 weeks prior to Screening
- •10.A history of short bowel syndrome (SBS)
- •11.Pregnant or nursing (lactating) women
- •12.Positive pregnancy test
- •13.Life expectancy <12 months from the Screening visit
- •14.Presence of any clinically significant findings at Screening medical history, or physical examination (relative to patient population) that, in the Investigator’s or Medical Monitor's opinion, would compromise patient safety or the outcome of the study
- •15.Any other clinically significant laboratory abnormality at Screening that would compromise patient safety or the outcome of the study
- •16.Clinically significant cardiac arrhythmia, bradycardia, tachycardia that would compromise patient safety or the outcome of the study.
- •17.A history of substance or alcohol abuse within 2 years prior to Screening
- •18.Administration of any investigational agent within 30 days of Screening or investigational therapeutic protein or antibody within 90 days prior to Screening
- •19.Previous exposure to telotristat etiprate
- •20.Patients who are currently committed to an institution by virtue of an order issued either by judicial or administrative authorities
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