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A Clinical Study With MT-102 in Subjects With Cancer Cachexia

This study has been completed.
Sponsor:
Collaborator:
Veeda Oncology
Information provided by (Responsible Party):
PsiOxus Therapeutics Ltd
ClinicalTrials.gov Identifier:
NCT01238107
First received: November 9, 2010
Last updated: September 9, 2014
Last verified: September 2014
  Purpose

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


Condition Intervention Phase
Cancer Cachexia
Drug: MT-102
Phase 2

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

Resource links provided by NLM:


Further study details as provided by PsiOxus Therapeutics Ltd:

Primary Outcome Measures:
  • 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 [ Time Frame: 16 weeks ] [ Designated as safety issue: No ]

Enrollment: 87
Study Start Date: April 2011
Study Completion Date: May 2013
Primary Completion Date: May 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: High dose Drug: MT-102
BETA BLOCKER
Other Name: MT-102
Experimental: Low dose Drug: MT-102
BETA BLOCKER
Other Name: MT-102
Placebo Comparator: Placebo Drug: MT-102
BETA BLOCKER
Other Name: MT-102

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. 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

  Eligibility

Ages Eligible for Study:   25 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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 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 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 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

    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 acceptable)
    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 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;
  21. History or diagnosis of brain metastases
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01238107

Locations
Germany
Charite Hospital Virchow-Klinikum Campus
Berlin, Germany, d-13352
India
Kumaran Hospital Private Ltd
Kilpauk, Chennai, India, 10
Dr Kamakshi Memorial Hospital
Pallikaranai, Chennai, India, 600100
Vedanta Institute of Medical Science
Ahmedabad, Gujarat, India, 380009
Shree Krishna Hopsital
Anand, Gujarat, India, 388325
Kailash Cancer Hospital & Research Centre
Goraj, Gujarat, India, 391760
TATA Memorial Hopsital
Mumbai, Maharashtra, India, 400012
Shatabdi Super Speciality Hospital
Nashik, Maharashtra, India, 422005
Curie Manavta Cancer Centre
Nashik, Maharashtra, India, 422004
Noble Hopsital
Pune, India, 411013
Malaysia
Hospital Sultahan Bahiyah
Alor Setar, Kedha, Malaysia, 05460
Hospital Universiti Sains Malaysia
Kubang Kerian, Kelantan, Malaysia, 16150
Hospital Universiti Kebangsaan Malaysia
Cheras, Kuala Lumpur, Malaysia, 56000
Universiti Malaya Medical
Jalan Baharu, Kuala Lumpur, Malaysia, 50603
Tuanku Ja'afar Hospital
Seremban, Negeri Sembilan, Malaysia, 70300
International Islamic University Malaysia
Kuantan, Pahang, Malaysia, 25200
Penang General Hopsital
Pulau Pinang, Penang, Malaysia, 10990
Hospital Umum Sarawak
Kuching, Sarawak, Malaysia, 93586
Sponsors and Collaborators
PsiOxus Therapeutics Ltd
Veeda Oncology
Investigators
Principal Investigator: Kumar n Pradhash, MD TATA MEMORIAL HOSPITAL , MUMBAI
  More Information

No publications provided

Responsible Party: PsiOxus Therapeutics Ltd
ClinicalTrials.gov Identifier: NCT01238107     History of Changes
Other Study ID Numbers: MT-102-2001
Study First Received: November 9, 2010
Last Updated: September 9, 2014
Health Authority: United Kingdom:Medicines and Healthcare Regulatory Agency
Belguim:Federal Agency for Medicines and Healthcare Products
India:Directorate General of Health Services
Malaysia:Ministry of Health Malaysia

Keywords provided by PsiOxus Therapeutics Ltd:
Cachexia
Cancer

Additional relevant MeSH terms:
Cachexia
Body Weight
Body Weight Changes
Emaciation
Signs and Symptoms
Weight Loss

ClinicalTrials.gov processed this record on November 24, 2014