Hormone refractory prostate cancer (HRPC)
Conditions
Interventions
Product Name: ZACTIMA
Product Code: ZD6474
Pharmaceutical Form: Tablet
INN or Proposed INN: vandetanib
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 100-
Pharmace
Sponsors
AstraZeneca AB
Eligibility
Sex/Gender
Male
Inclusion criteria
Inclusion criteria: 1. Provision of informed consent 2. Male patients aged 18 years and over 3. Metastatic hormone refractory prostate cancer defined as those patients with evidence of progression of disease in spite of castrate levels of testosterone indicated by rising levels of PSA. 4. Patients with a serum testosterone 12 weeks. 7. Screening PSA values > 20 ng/ml. This must be confirmed by two separate measurements at least 2 weeks apart 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. Treatment within 4 weeks before randomisation and/or whilst on study, treatment with the following: a non-approved or experimental drug; a drug with similar mechanism of action to ZD6474 2. Concurrent treatment with other anticancer agents, other than docetaxel and prednisolone as defined in the protocol. 3. Severe obstructive urinary symptoms or macroscopic haematuria 4. Major surgery within 4 weeks of randomisation or incompletely healed surgical incision 5. History of hypersensitivity to active or inactive excipients of ZD6474, docetaxel, prednisolone or placebo. 6. Current or prior malignancy within previous 3 years (other than prostate cancer or adequately treated basal cell or squamous cell carcinoma of the skin). 7. Any of the following laboratory values: total bilirubin > ULRR; ALT or AST > 2.5 x ULRR; serum creatinine > 1.5 x ULRR and creatinine clearance or =2) within 3 months before entry, or presence of cardiac disease that, in the opinion of the investigator, increases the risk of ventricular arrhythmia 11. History of arrhythmia (multifocal premature ventricular contractions, bigeminy, trigeminy, ventricular tachycardia, symptomatic or uncontrolled atrial fibrillation) which is symptomatic or requires treatment (CTCAE grade 3) or asymptomatic sustained ventricular tachycardia. Atrial fibrillation, controlled on medication, is not excluded 12. Congenital long QT syndrome or 1st degree relative with unexplained sudden death under 40 years of age 13. QT prolongation with other medication that requires discontinuation of that medication 14. Presence of left bundle branch block 15. QTc with Bazett’s correction unmeasurable or > or = 480msec or greater on screening ECG (Note: if patient has QTc interval > or = 480msec on screening ECG, the screen ECG may be repeated twice [at least 24 hours apart]. The average QTc from the 3 screening ECGs must be 160 mmHg or diastolic blood pressure >110 mmHg) 20. Involvement in the planning and conduct of the study (applies to both AstraZeneca staff or staff at the study site) 21. Previous enrolment or randomisation of treatment in the present study. 22. Any unresolved toxicity > Common Toxicity Criteria (CTC) grade 2 from previous anticancer therapy. 23. Brain metastases or spinal cord compression, unless treated at least 4 weeks before entry, and stable wit
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To assess the efficacy of ZD6474 in combination with docetaxel/prednisolone in the treatment of HRPC by the rate of prostate specific antigen (PSA) fall.;Secondary Objective: To assess the safety and tolerability of ZD6474 in combination with docetaxel and prednisolone in the treatment of HRPC by review of adverse events and laboratory parameters. To assess the efficacy of ZD6474/docetaxel/prednisolone treatment results in a lower relative risk of progression (after 8 months minimum follow-up) against docetaxel/prednisolone alone using the progression event count methodology. ;Primary end point(s): The primary outcome variable is defined as a PSA response. A PSA response is defined as a 50% reduction from baseline at any assessment. | — |
Countries
Germany, Hungary, Sweden
Outcome results
None listed