A multi-centre, double-blind, randomised, placebo-controlled, phase IIa exploratory study of the effects of Imidapril on body weight and body composition in Non-Small Cell Lung Cancer patients with cancer cachexia.
- Conditions
- Cancer Cachexia in Non-small Cell Lung CancerMedDRA version: 9.1Level: LLTClassification code 10064015Term: Cancer cachexia
- Registration Number
- EUCTR2007-004340-67-HU
- Lead Sponsor
- Ark Therapeutics Limited
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 150
1. Patients who have measurable NSCLC disease that has been histologically or cytologically proven and has been recently (= 18 months) diagnosed.
2. Male or female patients =18 and = 75 years of age.
3. Patients with a history of unintentional and undesired weight loss within 6 months of the screening visit.
4. BMI = 27.
5. Male and female patients must be using effective contraception if the risk of conception exists.
6. Patients who during the 6-week flexible placebo run-in period have a documented weight loss of:
- = 1 kg in any 2 weeks, or
- = 1.5 kg in 4 weeks, or
- = 1.75 kg in 6 weeks.
7. Patients who a) are not expected to undergo chemotherapy during the study or b) have already started a course of cycle/s of chemotherapy before the screening visit, where chemotherapy is defined as any anti tumour medication.
8. Patients with a life expectancy of = 6 months.
9. Patients with Karnofsky Performance score of = 60.
10. Patients (or legal representative) who provide signed 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 planning to commence chemotherapy (i.e. a course of treatment not prescribed prior to screening) after the screening visit.
2. Patients receiving or planning to receive cranial radiotherapy after the screening visit.
3. Patients with untreated thyrotoxicosis.
4. Patients with a pacemaker or other internal electrical medical device.
5. Patients receiving parenteral nutrition or enteral hyperalimentation.
6. Patients diagnosed with a Diagnostic and Statistical Manual-classified eating disorder such as anorexia nervosa or bulimia.
7. Patients at the screening or baseline visits with:
- low blood pressure defined as a sitting systolic blood pressure < 100 mmHg
- hypotension defined as grade 2 or greater according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE; formerly known as the National Cancer Institute Common Toxicity Criteria [NCI-CTC]), version 3.0
- clinical symptoms of postural hypotension or orthostatic changes in blood pressure, defined as a decrease in systolic blood pressure of > 20 mmHg or decrease in diastolic blood pressure of > 10 mmHg after shifting from a supine to sitting (with legs dependent) position.
8. Patients at the screening visit with a history of angioneurotic oedema
9. Patients with an active infection.
10. Patients with ascites or generalised oedema, requiring treatment.
11. Patients with renal disease (serum creatinine of > 2 mg/dL); or severe hepatic dysfunction (i.e., aspartate aminotransferase [AST], alanine aminotransferase [ALT], alkaline phosphatase [ALP], or bilirubin levels at toxicity grade 3 or 4 [according to the NCI CTCAE criteria, version 3.0]) at the screening visit.
12. Patients at the screening visit with hyperkalaemia, defined as grade 3 or 4 according to the NCI CTCAE criteria, version 3.0 (> 6.0 mmol/L).
13. Patients at the screening visit with neutrophil counts of < 1500/µL.
14. Patients who are concomitantly receiving any of the following:
- potassium-sparing diruetics
- lithium
- an anabolic regimen (including oxandralone, testosterone, or growth hormone)
- oestrogen and progestational agents (e.g. Megastrol), unless being taken for contraception purposes
- cyproheptadine hydrochloride, pentoxifylline, thalidomide, dronabinol (Marinol)
- angiotensin II antagonist or ACE inhibitor, including imidapril
- systemic steroids (other than for the treatment of chemotherapy induced nausea), or have been treated with systemic steroids for more than 21 consecutive days within the previous 3 months prior to the screening visit. [Low dose systemic steroids (equivalent to no more than 10mg prednisolone), given for a period of at least a month prior to screening, are permitted provided that their administration is stable and there is no anticipated change in use during the course of the study].
15. Patients who were treated with any investigational drug within 30 days or within five plasma half-lives (whichever is the longer) prior to screening visit.
16. Patients on any other clinical trial.
17. Patients who have known hypersensitivity to ACE inhibitors.
18. Patients who are not capable of fully understanding the study requirements or are unwilling/unable to comply with the study procedures.
19. Patients with malignancy (unless in remission) other than NSCLC.
20. Pregnant or lactating female patients.
21. Patients with a medical condition that, in the opinion of the inv
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: To explore the effects on body weight, muscle strength and body composition parameters including body cell mass (BCM) and lean body mass (LBM).<br>;Secondary Objective: - To explore the effects on health status/Quality of Life (QoL)<br>- To explore the effects on appetite<br>- To evaluate the safety and tolerability of oral imidapril<br>;Primary end point(s): - the rate of change and percentage change in BCM from randomisation to the end of study treatment, measured using the Quantum/STA bioimpedance analyser <br><br>- the rate of change and percentage change of LBM from randomisation to the end of study treatment, measured by bioimpedance<br><br>- the rate of change and percentage change in body weight using Tanita scales from randomisation to end of treatment <br><br>- the rate of change and percentage change in muscle strength (determined by hand-grip dynamometry measurements) from randomisation to the end of study treatment <br>
- Secondary Outcome Measures
Name Time Method