A Phase III, Multicentre, Double-Blind, Randomised, Placebo-Controlled, Parallel Group, Dose-Titration Study of Imidapril Hydrochloride (EG006) in the Treatment of Cancer Cachexia
- Conditions
- Level: PTClassification code 10006895Cancer Cachexia
- Registration Number
- EUCTR2004-000280-99-CZ
- Lead Sponsor
- Ark Therapeutics, Ltd.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 160
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
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.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: The primary aim of this trial is to evaluate the efficacy of oral imidapril hydrochloride (imidapril) compared to placebo in the treatment of weight loss in patients with advanced cancer or recurrent cancer;Secondary Objective: To assess the effects of oral imidapril compared to placebo on changes in body composition, muscle strength, fatigue, appetite, and health status. Also to evaluate the safety of oral imidapril in the treatment of patients with advanced cancer or recurrent cancer.;Primary end point(s):
- Secondary Outcome Measures
Name Time Method