EUCTR2004-000280-99-HU进行中（未招募）不适用
A Phase III, Multicentre, Double-Blind, Randomised, Placebo-Controlled, Parallel Group, Dose-Titration Study of Imidapril Hydrochloride (EG006) in the Treatment of Cancer Cachexia
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
- 160
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 patients >18 years of age. Female patients of childbearing potential must be using an acceptable method of contraception.
- •2. Patients with non-small cell lung cancer, colorectal adenocarcinoma or pancreatic cancer who have been diagnosed with advanced (unresectable) or recurrent illness.
- •3. Patients with unintentional and undesired weight loss, defined as loss of at least 5% of body weight within the previous 6 months, documented where possible.
- •4. Patients who are either a) not expected to undergo any chemotherapy during the study or b) who are commencing first line chemotherapy for metastatic or recurrent disease
- •5. Patients with life expectancy of >3 months.
- •6. Patients with Karnofsky performance score of >60.
- •7. Patients who provide written informed consent.
- •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. Patients with abnormal uncorrected thyroid status at the screening visit defined as serum TSH or free T4 values outside the normal range
- •2. Patients receiving parenteral nutrition or enteral hyperalimentation (patients with percutaneous endoscopic gastrostomy [PEG] feeding that is not for the purpose of hyperalimentation can enter study, provided that study medication tablets can be administered whole)
- •3. Patients diagnosed with a Diagnostic and Statistical Manual (DSM)-classified eating disorder such as anorexia nervosa or bulimia
- •4. Patients with low blood pressure defined as a sitting systolic blood pressure less than 100 mmHg at screening or baseline visits or with hypotension defined as grade 2 or greater according to the National Cancer Institute Common Toxicity Criteria [NCI-CTC, version 2.0]
- •5. Patients with a history of clinical symptoms of postural hypotension such as dizziness within the last 6 months
- •6. Patients with orthostatic changes in blood pressure, defined as a decrease in systolic blood pressure of greater than 20 mmHg or decrease in diastolic blood pressure of greater than 10 mmHg after shifting from a supine to sitting (with legs dependent) position at screening or baseline visits
- •7. Patients with an active, acute infection
- •8. Patients with a history of angioneurotic edema
- •9. Patients with ascites, generalized edema, or pleural effusion requiring treatment or likely to require treatment during the study
- •10. Patients with renal disease (serum creatinine of >2 mg/dL or >180 umol/L); or severe hepatic dysfunction (ie, aspartate aminotransferase, alanine aminotransferase, alkaline phosphatase, or bilirubin levels at toxicity grade 3 or 4 (according to the NCI-CTC criteria, version 2.0) at the screening visit
- •11. Patients with hyperkalemia, defined as grade 3 or 4 according to the NCI-CTC, version 2.0 (> 6.0mmol/L) at the screening visit
- •12. Patients with total white blood cell counts of <1500/uL at the screening visit
- •13. Patients who are concomitantly receiving any of the following during the course of the study: investigational drugs (other than the study medication), potassium-sparing diuretics, lithium, megestrol, an anabolic regimen (eg, oxandralone, testosterone, or growth hormone); ProsureTM, cyproheptadine hydrochloride, pentoxifylline, thalidomide; cannabinoids eg. dronabinol (Marinol); angiotensin II antagonist; angiotensin converting enzyme (ACE) inhibitor other than the study medication; tumor necrosis factor-alpha(TNF-alpha) antagonist; interleukin (IL)-1 antagonist; IL-2; or interferon.
- •14. Patients who have been treated with systemic steroids for more than 21 consecutive days within the previous 3 months prior to initiation of study medication.
- •15. Patients who will receive concomitant systemic steroids during the study, except for the treatment of chemotherapy side effects (eg, nausea, vomiting, joint pain, etc) for a maximum of 1 week per chemotherapy cycle during the course of the study
- •16. Patients who are receiving or are planned to receive upper abdominal radiotherapy or cranial radiotherapy
- •17. Patients who were treated with any investigational drug within 30 days or within 5 plasma half-lives (whichever is the longer) prior to the initiation of study medication.
- •18. Patients who have known hypersensitivity to ACE inhibitors.
- •19. Patients who are not capable of fully understanding the study requirements or are unwilling/ unable to comply with the study procedures.
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