A multicentre, randomised, double-blind, placebo-controlled, dose-finding phase II study to evaluate the efficacy of two different doses of MT-102 administered over a sixteen week period in subjects with cachexia related to stage III and IV non-small cell lung cancer and colorectal cancer
- Conditions
- Cachexia related to stage III and IV non-small cell lung cancer and colorectal cancerMedDRA version: 12.1Level: LLTClassification code 10064015Term: Cancer cachexia
- Registration Number
- EUCTR2010-022486-10-GB
- Lead Sponsor
- Myotec Therapeutics Limited
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised-recruitment may be ongoing or finished
- Sex
- All
- Target Recruitment
- Not specified
1.Adult patients aged between 25 to 80 years of age and with a life expectancy of greater than 3 months as judged by the treating physician.
2.Confirmed diagnosis of one of:
a.Non-curative stage III or stage IV Colorectal Cancer (CRC) not suitable for surgery, or
b.Non-curative stage III or stage IV Non-small Cell Lung Cancer (NSCLC) not suitable for surgery;
3.Patients who have a documented failure to respond or who have documented progression following a first line course of chemotherapy, with or without radiotherapy, with one of the following regimes:
a.For non-small cell lung cancer, a platinum based regimen
b.For colorectal cancer, a 5FU or Irinotecan based regimen
4.Cachexia with ongoing weight loss that in the opinion of the investigator is due to the underlying cancer.
5.Evidence of cachexia as judged by one of:
a. =5% documented weight loss in the previous 12 months; or
b.A subjective report of weight loss in the previous 12 months and a recorded body mass index (BMI) less than 20.0 kg/m2
6.At least two of the following:
a.Subjective report of decreased muscle strength
b.Subjective report of fatigue
c.Subjective report of anorexia
d.Abnormal biochemistry with one or more of the following:
i.CRP > ULN (as per Central Lab normal value)
ii.Anemia (< 12 g/dl)
iii.Low serum albumin (< 32 g/dl)
7.Patients of childbearing potential must use an effective method of avoiding pregnancy (including oral, transdermal, or implanted contraceptives; an intrauterine device; male or female condoms; diaphragm or cervical cap with spermicide; or abstinence) prior to randomisation and must agree to continue using such precautions until the end of the 140 day safety follow up;
8.Willing and able to comply with the protocol and to complete the study period;
9.Willing to forego other forms of experimental treatment during the study;
10.Signed and dated informed consent, prior to receipt of any study medication or any study related procedures.
11.ECOG performance status 0, 1 or 2
12.Able to complete the performance tests (SCP, SMWT, SPPB, HGS) at the screening visit and with two consecutive pre-randomisation SMWT results that differ by no more than 30% from each other
13.At least 80% compliant during the placebo run in period
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.Pregnancy or lactation at screen or baseline visit;
2.=20% weight loss in the previous 3 months or a BMI of less than 16 kg/m2
3.Age greater than 80 or less than 25 at baseline visit;
4.Scheduled to start any new course of chemotherapy or to undergo a change in present chemotherapeutic regimen during the dose escalation phase of the study (the first three weeks after randomisation);
5.Any surgical procedure within the past month or any planned surgical procedure;
6.Any mechanical obstruction of the alimentary canal;
7.Any history or evidence of intractable vomiting;
8.A history or clinical evidence of any hyperthyroidism, cirrhosis, hepatic failure, HIV, renal failure (as determined by a serum creatinine > 250µmol/ml or > 2.83 mg/dl at screen) or active tuberculosis (as confirmed by sputum or other microbiological methods, within the last five years);
9.Any physical, medical, socioeconomic or other non-cancer related cause for simple starvation, muscle wasting or weight loss;
10.Receiving enteral tube feeding or parenteral nutrition at screening or baseline visit;
11.Any clinical evidence of ascites or significant oedema or significant pleural effusion at screening or baseline visit;
12.Current or planned treatment with
a.Any oral adrenal corticosteroids (inhaled or topical steroids and short-term use of dexamethasone around the time of chemotherapy are acceptable);
b.Beta adrenergic blockers,
c.Non-dihydropyridine calcium antagonists (e.g. Verapamil, diltiazem),
d.Alpha adrenergic blockers,
e.Ivabradine (Coralan, Procoralan),
f.5HT agonists or antagonists e.g. SSRI’s,
g.MAOI’s,
h.Beta agonists,
i.Amiodarone,
j.ACE Inhibitors,
k.Megestrol, Anabolic Steroids or any other prescription medication intended to increase appetite or to treat unintentional weight loss.
13.Treatment with any investigational drug therapy within 28 days prior to the screening visit;
14.Previous history of administration of pindolol or s-pindolol;
15.History of allergy or reaction to any component of the MT 102/study drug formulation;
16.History or presence of congestive heart failure (with LVEF <45%) or uncontrolled hypertension (with BP >160/95 mm Hg);
17.Use of a pacemaker, implantable defibrillator, or internalized metal stent;
18.Resting pulse rate less than 68 beats per minute or high degree conduction defect on the electrocardiogram;
19.A resting supine systolic blood pressure less than 100 mm Hg.
20. A history of bronchospasm and bronchial asthma
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method