EUCTR2006-005607-33-DE
Active, not recruiting
Not Applicable
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 sitesMarch 21, 2007
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Prostate Cancer Metastatic
- Sponsor
- KOMINOX USA, Inc.
- Status
- Active, not recruiting
- Last Updated
- 14 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility 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
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
Outcomes
Primary Outcomes
Not specified
Similar Trials
Active, not recruiting
Phase 1
A Phase 1/2, Open-Label Study in Men with Prostate Cancer to Assess the Safety, Pharmacokinetics, and Testosterone-Lowering Efficacy of TAK-448, Administered as a 1 Month Depot, Including a Randomized Portion With a Group Administered LeuproreliProstate cancerMedDRA version: 12.1Level: LLTClassification code 10007113Term: Cancer of prostateEUCTR2009-017668-18-FRMillennium Pharmaceuticals, Inc.
Active, not recruiting
Not Applicable
Testing of a new drug in men with prostate cancer that may help lower testosterone levels.EUCTR2009-017668-18-BEMillennium Pharmaceuticals, Inc.123
Completed
Phase 2
Phase IIa Study of F-1311 in Patients with Prostate CancerProstate cancerJPRN-jRCT2080222723PDRadiopharma Inc.15
Completed
Phase 2
Phase IIb Study of F-1311 in Patients with Prostate CancerProstate CancerJPRN-jRCT2080223135PDRadiopharma Inc.56
Active, not recruiting
Phase 2
A study to investigate whether a combined Positron emission tomography (PET) and computerised tomography (CT) scan which utilises a tracer called Prostate Specific Membrane Antigen (PSMA) - a substance expressed by prostate cancer cells - can be used to better identify locally recurrent prostate cancer in men with a rising Prostate Specific Antigen (PSA) following radical prostatectomy. The study will then measure the impact of early salvage radiation therapy using advanced localisation techniques on patient survival, clinical toxicity, health related quality of life and prostate cancer-specific quality of life.Recurrent prostate cancerCancer - ProstateACTRN12615001183572Icon Cancer Foundation110