EUCTR2006-005607-33-DE进行中（未招募）不适用
A Clinical Phase II Study in Patients with Prostate Cancer and Bone Metastases with KML001 (KOMINOX®) - KML001 in patients with prostate cancer and bone metastases
KOMINOX USA, Inc.0 个研究点开始时间: 2007年3月21日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- Male
入选标准
- •1. patients with hormone-refractory prostate cancer
- •2. prostate cancer confirmed histologically or cytologically (Gleason score = 7 or histological grade = 3)
- •3. PSA at least 10 ng/ml
- •4. at least one bone metastasis confirmed by bone scintigraphy as well as computer tomography
- •5. patients receiving androgen suppression treatment with LH-RH analogues and/or anti-androgens and showing complete androgen blockade defined as baseline total testosterone level of up to 0.5 ng/ml
- •6. prostate cancer no longer amenable to established forms of therapy
- •7. age over 18 years
- •8. overall life expectancy >16 weeks
- •9. informed consent given in a written form after being provided with detailed information about the nature, risks, and scope of the clinical trial as well as the expected desirable and adverse effects of the drug
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range
排除标准
- •1. patients who are at visit 1 not eligible for treatment according to the criteria relevant for chemotherapy (i.e. one of following criteria is present):
- •- Zubrod score higher than 2,
- •- hemoglobin lower than 100 g/l,
- •- neutrophils <1,5 G/l,
- •- platelets <100 G/l,
- •- creatinine >140 mmol/l,
- •- ALT, AST >2 times above upper reference range for patients without liver metastasis,
- •- ALT, AST >5 times above upper reference range for patients with liver metastasis
- •2. any concomitant cancer therapy within 30 days before the first administration of study medication or during the study other than stable therapy with LH-RH analogues, anti-androgens, and/or bisphosphonates
- •3. change of concomitant treatment with LH-RH analogues, anti-androgens, or bisphosphonates within 6 weeks before the first administration of study medication or during the study
- •4. any concomitant other cancer type
- •5. QTc prolongation above 500 ms
- •6. concomitant severe arrhythmias
- •7. known history of increased risk for torsade de pointes (TdP) like hypokalemia, family history of Long-QT-Syndrome
- •8. present moderate to severe heart failure (NYHA class III-IV)
- •9. brain metastases
- •10. history of major gastrointestinal surgery or pathology (such as severe malabsorption) likely to influence absorption of the study medication
- •11. severe dehydration
- •12. treatment with parenteral antibiotics within 7 days before randomization
- •13. patients on hemodialysis
- •14. patients with clinically manifested liver failure (ascites or esophageal varices)
- •15. uncontrolled hypertension at visit 1
- •16. known hypersensitivity to any of the active or inactive components of the final product
- •17. symptoms suggestive of serious acute arsenic toxicity after treatment start (e.g. convulsions, muscle weakness and confusion)
- •18. patients with hemodynamically relevant bleeding
- •19. severe physical or mental concomitant diseases that might hamper the realization of the trial according to protocol or the evaluation of efficacy or safety
- •20. participation in another clinical trial within the last 28 days
- •21. legal incapacity and/or other circumstances rendering the patient unable to understand the nature, scope and possible consequences of the study
- •22. unreliability or lack of cooperation
- •23. lack of a possibility to attend the visits required by protocol
研究者
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