KCT0003574已完成未知
A Phase I Study of KOMINOX (KML001) for Refractory or Recurrent Solid Tumors
试验速览
- 阶段
- 未知
- 状态
- 已完成
- 入组人数
- 42
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional Study
入排标准
- 年龄范围
- 18(Year) 至 o Limit（—）
- 性别
- All
入选标准
- •1.Over 18 years old
- •2.Histologically or cytologically confirmed solid tumors.
- •3.Inoperable, metastatic or locally advanced solid tumors that are refractory or recurrent after the failure of standard of care treatment.
- •4.Nonexistence of standard of care treatment or a situation where such treatment is no longer effective.
- •5.Having agreed to provide tissue blocks or tissue biopsy samples.
- •6.Life expectancy = 3 months.
- •7.Having fully recovered from the toxicities caused by the previous anticancer treatment.
- •8.Performance status = 2.
- •9.Adequate bone marrow function: ANC = 1,500/ µL, hemoglobin = 9.0g/dL (hemoglobin level corrected by blood transfusions is allowed), and platelet = 100,000/µL.
- •10.Adequate renal function (serum creatinine within the normal range or CCr = 60 ml/min).
- •11.Serum electrolyte levels (including calcium, magnesium, phosphorus, and potassium) within the normal ranges (a patient whose serum electrolyte levels are outside the normal ranges may still participate in the study if these levels are considered by the investigator to be clinically insignificant). Supplementation for serum electrolyte normalization is allowed. The normal ranges and allowable abnormal ranges (if considered by the investigator to be clinically insignificant) of serum electrolyte levels are presented in the table below.
- •Sodium (Na) 133 ~ 146mmol/L
- •Potassium (K) 3.3 ~ 5.5 mmol/L
- •Calcium (Ca) 8.3 ~ 10.5mg/dl
- •Magnesium(Mg) 58 ~ 3.0mg/dl
- •Phosphorus (P)2.5 ~ 4.5 (same as the normal range)mg/dl
- •Chlorine (Cl) 96 ~ 112mmol/L
- •12.Adequate hepatic function (serum bilirubin < 2 x upper limit of normal (ULN), AST/ALT < 2.5 x ULN, ALP < 5 x ULN; AST/ALT < 5 x ULN for liver metastasis).
- •13.Any previous chemotherapy, hormone therapy, radiotherapy, and surgery must have been done at least 4 weeks prior to the first dosing of the investigational product. The radiation field must not be the only measurable lesion (gamma knife surgery must be performed at least 1 week prior to the investigational product administration).
- •14.Corrected QT interval (QTc, Bazett’s fomular) = 0.48 seconds on the electrocardiogram (ECG)
- •15.A patient who voluntarily decides to participate in the study and provides written informed consent after being informed of the nature, risks, and scope of the study as well as expected desirable and undesirable effects of the study drug.
- •16.Agreement to use effective contraceptive methods for patients of reproductive potential.
排除标准
- •1.Evidence of brain metastasis with uncontrolled symptoms (radiologically and neurologically stable brain metastasis after corticosteroid withdrawal at least 2 weeks prior to the study may be allowed).
- •2.Unable to take drugs orally or having malabsorption.
- •A patient must not have a history of the following clinically significant gastrointestinal malabsorption: malabsorption syndrome; resection of the stomach or small intestines that may affect the study drug absorption; active gastric ulcer disease; inflammatory bowel disease; ulcerative colitis; other gastrointestinal diseases that may increase the risk for the development of perforation; history of abdominal fistula; gastrointestinal perforation, or; intraabdominal abscess within 28 days prior to the study treatment initiation.
- •3.Previous treatment with arsenic compounds.
- •4.Treatment with parenteral antibiotics within 7 days prior to the study participation.
- •5.History of cancer within the past 5 years, except for skin basal cell carcinoma, in situ carcinoma of the cervix, and papillary thyroid cancer.
- •6.Active bacterial infections requiring antibiotics treatment.
- •7.Grade 2 or higher peripheral neuropathy.
- •8.Corrected (Bazett) QTc interval > .50 ms (male) or > .52 ms (female).
- •9.Known history of elevated risks for torsade de point (TdP), such as hyperkalemia, or family history of long QT syndrome.
- •10.Having been diagnosed with myocardial infarction within 6 months prior to the study participation or having NYHA class 3 or 4 congestive heart failure or other clinically poorly controlled heart diseases (e.g., uncontrolled hypertension with diastolic blood pressure (BP) > 100 or systolic BP > 180, unstable angina pectoris, cardiomyopathy with < 45% ejection fraction, arrhythmia).
- •11.Pregnant or lactating patients.
- •12.Women of childbearing potential who do not agree to use effective contraceptive methods during the study and up to 3 months following the end of study (women who have undergone hysterectomy or bilateral tubal ligation or who are postmenopausal may be included in the study) or men of reproductive potential who do not agree that their partners or themselves will use effective contraceptive methods during the study and up to 3 months following the end of study.
- •13.Systemic diseases which make anticancer treatment inadequate (e.g., chronic hepatic disease, chronic renal disease, active hepatitis, poorly controlled diabetes mellitus).
- •14.Administration of another investigational product within 28 days prior to enrollment.
- •15.Known hypersensitivities to any of the active or inactive components of this product.
- •16.Acquired immune deficiency syndrome.
- •17.Having been treated for chronic obstructive pulmonary disease or respiratory disease within 4 weeks.
- •18.PT or PTT > 1.5 x ULN (except for anticoagulant users, in which case, stabilized PT/PTT over 2 weeks must be confirmed).
- •19.Use of drugs that may prolong QT intervals and are associated with torsades de points. See http://www.azcert.org/medicalpros/drug-lists/drug-lists.cfm.
- •20.A patient or his/her guardian unable to understand written informed consent or not giving the consent.
- •21.A patient considered by the investigator to be inappropriate for this study.
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