Status:
COMPLETED
A Clinical Study With MT-102 in Subjects With Cancer Cachexia
Lead Sponsor:
Akamis Bio
Collaborating Sponsors:
Veeda Oncology
Conditions:
Cancer Cachexia
Eligibility:
All Genders
25-80 years
Phase:
PHASE2
Brief Summary
A phase II clinical study to evaluate MT-102 administered over a sixteen week period in subjects with cachexia related to non-small cell lung cancer and colorectal cancer
Detailed Description
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....
Eligibility Criteria
Inclusion
- 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 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
Exclusion
- 1\. Pregnancy or lactation at screen or baseline visit;
- ≥20% weight loss in the previous 3 months or a BMI of less than 16 kg/m2
- Age greater than 80 or less than 25 at baseline visit;
- 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);
- Any surgical procedure within the past month or any planned surgical procedure;
- Any mechanical obstruction of the alimentary canal;
- Any history or evidence of intractable vomiting;
- 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);
- Any physical, medical, socioeconomic or other non-cancer related cause for simple starvation, muscle wasting or weight loss;
- Receiving enteral tube feeding or parenteral nutrition at screening or baseline visit;
- Any clinical evidence of ascites or significant oedema or significant pleural effusion at screening or baseline visit;
- Current or planned treatment with
- Any oral adrenal corticosteroids (inhaled or topical steroids and short-term use of dexamethasone around the time of chemotherapy are acceptable);
- Beta adrenergic blockers,
- Non-dihydropyridine calcium antagonists (e.g. Verapamil, diltiazem),
- Alpha adrenergic blockers,
- Ivabradine (Coralan, Procoralan),
- 5HT agonists or antagonists e.g. SSRI's, , (short-term use around the time of chemotherapy are acceptable)
- MAOI's,
- Beta agonists, (short term or on-and -off use of inhaled broncho-dilators are acceptable)
- Amiodarone,
- Megestrol, Anabolic Steroids or any other prescription medication intended to increase appetite or to treat unintentional weight loss.
- Treatment with any investigational drug therapy within 28 days prior to the screening visit;
- Previous history of administration of pindolol or s-pindolol;
- History of allergy or reaction to any component of the MT 102/study drug formulation;
- History or presence of congestive heart failure (with LVEF \<45%) or uncontrolled hypertension (with BP \>160/95 mm Hg);
- Use of a pacemaker, implantable defibrillator, or internalized metal stent;
- Resting pulse rate less than 68 beats per minute or high degree conduction defect on the electrocardiogram;
- A resting supine systolic blood pressure less than 100 mm Hg.
- A history of bronchospasm and bronchial asthma;
- History or diagnosis of brain metastases
Key Trial Info
Start Date :
April 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2013
Estimated Enrollment :
87 Patients enrolled
Trial Details
Trial ID
NCT01238107
Start Date
April 1 2011
End Date
May 1 2013
Last Update
September 10 2014
Active Locations (18)
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1
Charite Hospital Virchow-Klinikum Campus
Berlin, State of Berlin, Germany, d-13352
2
Kumaran Hospital Private Ltd
Kilpauk, Chennai, India, 10
3
Dr Kamakshi Memorial Hospital
Pallikaranai, Chennai, India, 600100
4
Vedanta Institute of Medical Science
Ahmedabad, Gujarat, India, 380009