hormone-resistant prostate cancer MedDRA version: 6.1 Level: LLT Classification code 10062904 Term:
Conditions
Interventions
Product Name: ZD4054
Product Code: ZD4054
Pharmaceutical Form: Tablet
Current Sponsor code: ZD4054
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 10-
Pharmaceutica
Sponsors
AstraZeneca AB
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 radionuclide bone scan. Patients must have disease involvement =65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1.Radiotherapy to bone lesion or prostatic bed within 4 weeks of starting study treatment 2.Current use (from the time that written informed consent is given) of any opiates, with the exception of opiates taken PRN for pain not directly related to prostate cancer 3.Prior cytotoxic chemotherapy (such as paclitaxel, docetaxel and mitoxantrone) for the treatment of recurrent prostate cancer (prior estramustine therapy is allowed), as well as other targeted cancer therapies (such as EGF, EGFR, VEGF and VEGFR) 4.Systemic radionuclide therapy (ie, strontium chloride Sr89, 186Relabeled HEDP, or 153Sm-EDTMP pentasodium) within 12 weeks of starting study treatment 5.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 6.Use of systemic retinoids within 2 weeks of starting study treatment 7.Have received investigational drug in another clinical study of anticancer therapy, within 4 weeks of starting study treatment 8.Prior therapy with endothelin receptor antagonists or family history of hypersensitivity to endothelin antagonists 9.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 10.Symptomatic peripheral neuropathy of CTCAE grade 2 or higher 11.Known or suspected central nervous system metastases 12.History of past or current epilepsy, epilepsy syndrome, or other seizure disorder 13.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 14.QT interval corrected for heart rate eg, by Bazett’s correction >470 msec 15.Previous history or presence of another malignancy, other than prostate cancer or treated squamous/basal cell carcinoma of the skin, within the last 5 years 16.In the opinion of the investigator, any evidence of severe or uncontrolled systemic disease (eg, 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 17.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 19.Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) >2.5 times the ULN or 5 times the ULN in the presence of liver metastasis 20.Creatinine clearance of <50 mL/minute, determined using the Cockcroft-Gault equation or by 24-hour creatinine clearance 21.Patients who discontinue after randomisation cannot be re-enrolled. Patients who fail to meet the inclusion/exclusion criteria may be reconsidered once for participation in the study. Patients who are re-enrolled must be re-consented and will be assigned a new enrolment number 22.Involvement
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To determine the effect of ZD4054 on overall survival, defined as time to death (from randomisation) from any cause, compared to placebo;Secondary Objective: 1.To assess the effect of ZD4054 on progression free survival, defined as time from randomisation into the study until clinical progression of disease, compared to placebo 2.To investigate the tolerability and safety profile of ZD4054 compared to placebo 3.To assess the effect of ZD4054 on time to use of opiates compared to placebo 4.To assess the effect of ZD4054 on the incidence of skeletal related events compared to placebo 5.To investigate the effects of ZD4054 on bone metastases formation compared to placebo 6.To assess the effects of ZD4054 on Health Related Quality of Life (HRQOL) compared to placebo 7.To investigate the effect of ZD4054 on time to prostate-specific antigen (PSA) progression compared to placebo 8.To assess the effects of ZD4054 on time to pain progression compared to placebo 9.To investigate the effects of ZD4054 on time to initiation of chemotherapy compared to placebo 10.To investigate the pharmacokinetic characteristics of ZD4054 ;Primary end point(s): Overall survivan defined as Time to death (from randomisation) from any cause | — |
Countries
Austria, Belgium, Denmark, Finland, France, Germany, Hungary, Italy, Netherlands, Portugal, Sweden, United Kingdom
Outcome results
None listed