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

• Conditions: Prostate Cancer Metastatic; MedDRA version: 8.1Level: LLTClassification code 10036909Term: Prostate cancer metastatic

• Registration Number: EUCTR2006-005607-33-DE
• Lead Sponsor: KOMINOX USA, Inc.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2007-03-21
• Last Update Posted: 19 March 2012

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Male
• Target Recruitment: Not specified

Inclusion Criteria

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

Exclusion Criteria

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

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified