Health Condition 1: null- Patients with cachexia related to stage III and IV non-small cell lung cancer and colorectal cancer
Conditions
Interventions
Intervention1: MT-102: 1x 2.5mg tablet of MT-102 two times per day
1x 2.5mg tablet of MT-102 + 1 placebo tablet two times per day
1x 2.5mg tablet of MT-102 + 3 placebo tablet two times per day
1 x 2.5
Sponsors
Myotec Therapeutics Ltd
Veeda Clinical Research Pvt Ltd
Eligibility
Inclusion criteria
Inclusion criteria: 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. less than or equal to 5 percent 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 per 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 less than ULN (as per Central Lab normal value) ii. Anemia (greater than 12 g per dl) iii. Low serum albumin (less than 3.2 g per 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 percent from each other 13. At least 80 percent compliant during the placebo run in period.
Exclusion criteria
Exclusion criteria: 1. Pregnancy or lactation at screen or baseline visit. 2. 20 percent weight loss in the previous 3 months or a BMI of less than 16 kg per m2 3. Age greater than 80 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 250 mmol per ml 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 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 (eg Verapamil, diltiazem), d. Alpha adrenergic blockers, e. Ivabradine (Coralan), f. 5HT agonists or antagonists e.g. SSRIs, g. MAOIs, h. Beta agonists, i. Amiodarone, j. ACE Inhibitors, k. Megace, Marinol, 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 MT-102; 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 percent) 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Demonstrate the effect of a 10mg / bd dose of MT-102 in comparison to placebo on the rate of weight change over a sixteen week periodTimepoint: Day 7, 14, 21, 28, 56, 84, 112 and 140. | — |
Secondary
| Measure | Time frame |
|---|---|
| Demonstrate the dose response effects of two different doses of MT-102 in comparison to placebo over a sixteen week period: The Slope of weight change The Short Physical Performance Battery test (SPPB)The six minute walk test (SMWT)Hand grip strength (HGS)Measures of quality of life (QOL)Change of body composition according to Dual Energy X-ray Absorbitometry(DEXA) All cause mortality The adverse event profile Inflammatory, neuroendocrine and catabolic / anabolic biomarkersTimepoint: Day 7, 14, 21, 28, 56, 84, 112, and 140. | — |
Countries
Belgium, India, Malaysia, United Kingdom
Contacts
Public ContactDr Kiran Marthak
Outcome results
None listed