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A Multicentre, Randomised, Double-blind, Placebo-controlled, Phase II Clinical Study to Evaluate Doses of MT-102 in Subjects With Cachexia Related to Stage III and IV Non-small Cell Lung Cancer and Colorectal Cancer

Phase 2
25 Years
80 Years
Not Enrolling
Cancer Cachexia

Thank you

Trial Information

A Multicentre, Randomised, Double-blind, Placebo-controlled, Phase II Clinical Study to Evaluate Doses of MT-102 in Subjects With Cachexia Related to Stage III and IV Non-small Cell Lung Cancer and Colorectal Cancer

Cachexia is a wasting disease, associated with significant morbidity and mortality,
accompanying a wide range of serious illnesses, for which there are currently no widely
approved therapeutic agents. Cachexia is defined as weight loss, associated with a chronic
underlying disease, of at least 5% in 12 months or less. It is associated with fatigue, loss
of muscle strength, a low fat free index and neurohormonal and biochemical abnormalities.

Cancer cachexia occurs in about a third of all patients with cancer and has been estimated
to be the direct cause of death in up to 20% of all cancer related deaths. As with other
solid tumours, colorectal cancer (CRC) and non-small cell lung cancer (NSCLC) have
relatively high incidences of cachexia, approximately 28% and 34% respectively.Through its
combined pharmacological actions, MT-102 has a multi-functional effect upon three potential
pharmacological targets, each of which is relevant for cancer cachexia

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 are receiving or who have already received a course of chemotherapy,
with or without radiotherapy or surgery, 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 c. Ongoing documented weight loss of at least 1kg in the week prior
to day 0; or 1.25kg in the 2 weeks prior to day 0, or 1.5kg in the 3 to 6 weeks prior
to day 0; provided that BMI is not more than 25.

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 (< 3.2 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

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

Exclusion Criteria:

1. 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/l 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

11. Any clinical evidence of ascites or significant oedema or significant pleural
effusion at screening or baseline visit;

12. Current or planned treatment with

1. Any oral adrenal corticosteroids (inhaled or topical steroids and short-term use
of dexamethasone around the time of chemotherapy are acceptable);

2. Beta adrenergic blockers,

3. Non-dihydropyridine calcium antagonists (e.g. Verapamil, diltiazem),

4. Alpha adrenergic blockers,

5. Ivabradine (Coralan, Procoralan),

6. 5HT agonists or antagonists e.g. SSRI's, , (short-term use around the time of
chemotherapy are acceptable)

7. MAOI's,

8. Beta agonists, (short term or on-and -off use of inhaled broncho-dilators are

9. Amiodarone,

10. 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

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;

21. History or diagnosis of brain metastases

Type of Study:


Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Outcome Measure:

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 period in patients with cachexia related to underlying stage III and stage IV colorectal or non-small cell lung cancer

Outcome Time Frame:

16 weeks

Safety Issue:


Principal Investigator

Kumar n Pradhash, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:



United Kingdom:Medicines and Healthcare Regulatory Agency

Study ID:




Start Date:

April 2011

Completion Date:

May 2013

Related Keywords:

  • Cancer Cachexia
  • Cachexia
  • Cancer
  • Cachexia