CTRI/2011/05/001757尚未招募2 期
A multicentre, randomised, double-blind, placebo controlled,dose-finding phase II clinical 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 - Not applicable
Myotec Therapeutics Ltd0 个研究点目标入组 132 人开始时间: 待定最近更新:
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 132
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
入选标准
- •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.
排除标准
- •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.
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