NCT01238107已完成2 期
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
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- Akamis Bio
- 入组人数
- 87
- 试验地点
- 18
- 主要终点
- 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
研究概览
简要总结
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
详细描述
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
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 25 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
- •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;
- •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
- •Cachexia with ongoing weight loss that in the opinion of the investigator is due to the underlying cancer.
- •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
- •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)
- •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;
- •Willing and able to comply with the protocol and to complete the study period;
- •Willing to forego other forms of experimental treatment during the study;
- •Signed and dated informed consent, prior to receipt of any study medication or any study related procedures.
- •ECOG performance status 0, 1 or 2
- •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
- •At least 80% compliant during the placebo run in period
排除标准
- •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)
- •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
研究组 & 干预措施
High dose
Experimental
干预措施: MT-102 (Drug)
Low dose
Experimental
干预措施: MT-102 (Drug)
Placebo
Placebo Comparator
干预措施: MT-102 (Drug)
结局指标
主要结局
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
时间窗: 16 weeks
次要结局
未报告次要终点
研究者
研究点 (18)
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