Castration-refractory prostate cancer prior treated with chemo therapy MedDRA version: 12.0 Level: LLT Classification code 10036909 Term: Prostate cancer metastatic
Conditions
Interventions
Product Code: ZD4054
Pharmaceutical Form: Tablet
Current Sponsor code: ZD4054
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 10-
Sponsors
Dept of Urology Aarhus Universityhospital
Eligibility
Sex/Gender
Male
Inclusion criteria
Inclusion criteria: 1. Provision of informed consent 2. Male, aged 18 years or older 3. Histological or cytological confirmation of adenocarcinoma of the prostate 4. Documented evidence of bone metastasis on bone scans. 5. Surgically castrated or continuously medically castrated with serum testosterone ?2.4 nmol/L (70 ng/dL). 6. Previously (not inside 8 weeks) treated with at least two times 75 mg/m2 docetaxel. 7. Biochemical progression of prostate cancer after chemotherapy, documented while the patient is castrate: o Biochemical progression is defined as at least 2 stepwise increases (=1ng/mL) in PSA over a period of =1 month (values do not need to be consecutive but 2 values that have increased since the previous highest value are required) with at least 14 days between each measurement irrespective of assay or laboratory. 8. Life expectancy of 3 months or more. 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. Use of potent CYP450 inducers (such as phenytoin, rifampicin, carbamazepine, phenobarbitone and St John’s Wort) within 2 weeks of starting study treatment. Dexamethasone will be allowed if the investigator feels it is necessary but is encouraged to use a different form of steroid treatment wherever possible 2. Have received investigational drug in another clinical study of anticancer therapy, within 4 weeks of starting study treatment 3. Hypersensitivity to endothelin antagonists 4. Neurological symptoms or signs consistent with acute or evolving spinal cord compression. If a patient has neurologic symptoms, an MRI must be performed that demonstrates no impending or actual spinal cord compression. Stable, previously treated patients are allowed 5. History of past or current epilepsy, epilepsy syndrome, or other seizure disorder 6. Stage II, III or IV cardiac failure (classified according to New York Heart Association (NYHA) classification) or myocardial infarction within 6 months prior to study entry 7. QT interval corrected for heart rate e.g., by Bazett’s correction >470 msec 8. In the opinion of the investigator, any evidence of severe or uncontrolled systemic disease (e.g., currently unstable or uncompensated respiratory, cardiac, hepatic or renal disease) or evidence of any other significant clinical disorder or laboratory finding that makes it undesirable for the patient to participate in the study 9. Hemoglobin (Hb) 1.5 times the upper limit of normal (ULN). This will not apply to patients with Gilbert’s syndrome (persistent or recurrent hyperbilirubinemia that is predominantly unconjugated in the absence of evidence of haemolysis or hepatic pathology), who will be allowed in consultation with their physician 11. Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) >2.5 times the ULN or 5 times the ULN in the presence of liver metastasis 12. Creatinine clearance of <50 mL/minute, determined using the Cockcroft-Gault equation or by 24-hour creatinine clearance
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary objective of this study is: To assess the safety and tolerability profile of ZD4054 after treatment with chemotherapy ? Adverse events ? Vital signs ? Laboratory data ? ECGs ? Physical Exam ? Death from any cause ;Secondary Objective: 1. To investigate the effect of ZD4054 on rate of rise of PSA 2. To investigate the effect of ZD4054 on prostate cancer related pain 3. To investigate the effect of ZD4054 on the plasma concentration of circulating tumour cells (CTC). ;Primary end point(s): The primary outcome variable is safety and tolerability as assessed by adverse event data. | — |
Countries
Denmark
Outcome results
None listed