ISRCTN66719785已完成2 期
A phase II open label dosing study to optimise vitamin D levels prior to oesophagectomy
niversity of Birmingham (UK)0 个研究点目标入组 18 人开始时间: 2011年9月26日最近更新:
适应症
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 18
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
- 性别
- All
入选标准
- •1. Planned transthoracic oesophagectomy for oesophageal carcinoma at a participating centre
- •2. Aged over 16 years on day of first dose of Investigational Medicinal Product (IMP)
- •3. Ability to give written informed consent to participate in the study
排除标准
- •1. Known intolerance of vitamin D
- •2. Known sarcoidosis, hyperparathyroidism, or nephrolithiasis
- •3. Taking more than 1000iu/day vitamin D supplementation in the month preceding enrolment
- •4. Baseline serum corrected calcium > 2.65 mmol/L
- •5. Undergoing haemodialysis
- •6. Pregnant or breastfeeding
- •7. Taking cardiac glycoside, carbamazepine, phenobarbital, phenytoin, primidone or long-term immunosuppressant therapy
- •8. Taking oral preparation containing > 10 micrograms vitamin D/day up to 2 months before first dose of IMP
- •9. Diagnosis of chronic obstructive pulmonary disease (COPD) with an forced expiratory volume in one second (FEV1) less than 50% predicted or resting oxygen saturations of less 92%
研究者
相似试验
进行中（未招募）
1 期
what dose of vitamin D is the right one trialperioperative inflammation in patients undergoing oesophagectomy.EUCTR2011-004199-12-GBniversity of Birmingham18
招募中
不适用
A phase 1b, dose finding, open label study of the safety and tolerability of carboplatin-cyclophosphamide combined with atezolizumab, an antibody that targets programmed death ligand 1 (PD-L1), in patients with advanced breast cancer, ovarian, cervical and endometrial cancer.breast cancerNL-OMON45572ederlands Kanker Instituut12
进行中（未招募）
不适用
An open label dose adjustment and phase II study of E7070 in combination with capecitabine: Part 1: to determine the recommended dose of the combination Part 2: to determine the efficacy of the combination in patients with metastatic colorectal cancer (CRC) who are resistant to or unsuitable for treatment with 5-fluorouracil and irinotecan and/or oxaliplatiEUCTR2004-002597-33-DEEisai Ltd22
进行中（未招募）
不适用
A phase Ib study to determine the maximum starting dose and to evaluate safety, pharmacokinetic and efficacy profiles of INC424 in myelofibrosis patients who have thrombocytopenia.EUCTR2010-023055-29-NLovartis Pharma Services AG62
进行中（未招募）
不适用
A Phase Ib, open-label, dose-finding study of the JAK inhibitor INC424 tablets administered orally to patients with Primary Myelofibrosis (PMF), Post-Polycythemia Vera-Myelofibrosis (PPV-MF) or Post-Essential Thrombocythemia-Myelofibrosis (PET-MF) and baseline platelet counts = 50 x109/L and <100 x109/Primary Myelofibrosis (PMF), Post-Polycythemia Vera-Myelofibrosis (PPV-MF) or Post-Essential Thrombocythemia-Myelofibrosis (PET-MF)MedDRA version: 14.0Level: PTClassification code 10028537Term: MyelofibrosisSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)EUCTR2010-023055-29-ATovartis Pharma Services AG62