Prostate Cancer Metastatic MedDRA version: 8.1 Level: LLT Classification code 10036909 Term: Prostate cancer metastatic
Conditions
Interventions
Product Name: Sodium Meta-Arsenite
Product Code: KML001
Pharmaceutical Form: Tablet
INN or Proposed INN: sodium meta-arsenite
CAS Number: 7784-46-5
Concentration unit: mg milligram(s)
Concentration ty
Sponsors
KOMINOX USA, Inc.
Eligibility
Sex/Gender
Male
Inclusion criteria
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
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 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To establish the effective dose of KML001 based on the percentage of patients with PSA response, defined as a reduction of at least 30% from baseline, in patients with hormone-refractory prostate cancer with bone metastases.;Secondary Objective: To evaluate the efficacy and safety of different doses of KML001 based on the remaining efficacy and safety parameters.;Primary end point(s): percentage of patients with PSA response, defined as a reduction of at least 30% from baseline | — |
Countries
Germany
Outcome results
None listed