None listed
Conditions
Interventions
Group 1 Type of group
10 mg of ZD4054 administered orally once a day in the form of tablets until a discontinuation criterion is met.
Group name:Group 2 Type of group
Placebo administered orally once a day in the form of tablets until a discontinuation criterion is met.
Sponsors
AstraZeneca AB,
Eligibility
Sex/Gender
Male
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: • Provision of informed consent • Male, 18 years of age or older • Histological or cytologic confirmation of prostate adenocarcinoma • No evidence of metastatic disease, local recurrence or pelvic lymph node disease in: Chest CT, CT or MRI of the abdomen / pelvis, Bone scintigraphy • Biochemical progression of prostate cancer, documented even if the patient is neutered. • Castrated surgically or medically castrated continuously with serum testosterone <2.4 nmol / 1 (70 ng / dl), with stable treatment for 8 weeks • Performance status of the World Health Organization (QMS) 0-1 • Life expectancy of 6 or more months.
Exclusion criteria
Exclusion criteria: • Current use (from the time you provided informed consent) of any opioid, with the exception of opiates taken PRN for symptoms unrelated to the disease • Definitive treatment to treat the patient´s primary prostate cancer (prostatectomy, radiotherapy, cryotherapy) within 3 months of entering the study • Previous cytotoxic chemotherapy (such as paclitaxel, docetaxel, and mitoxantrone) for the treatment of recurrent prostate cancer (prior treatment with estramustine is allowed), as well as other treatments directed against cancer (such as EGF, EGFR, VEGF, and VEGFR) • Use of intravenous bisphosphonates in the 6 months prior to the start of study treatment. Oral bisphosphonates are allowed for the prevention and / or treatment of osteoporosis. The dose of oral bisphosphonate should be stable for a minimum of 4 weeks before starting the study treatment. Intravenous bisphosphonates are allowed after the progression of the disease, however, the dose in the study should be stable. • Use of potent inducers of CYP450 (such as phenytoin, rifampicin, carbamazepine, and phenobarbitone, St John´s Wort) within 2 weeks of the start of study treatment. Dexamethasone will be allowed if the investigator believes it is necessary but the use of a different form of steroid treatment is encouraged whenever possible • Use of systemic retinoids within 2 weeks of the start of study treatment • Having received a research medication in another clinical trial of cancer treatment, within 4 weeks of the start of study treatment • Previous treatment with endothelin receptor antagonists or family history of hypersensitivity to endothelin antagonists • History of epilepsy, epileptic syndrome or other seizure disorder, past or present • Stage II, III or IV heart failure (classified according to the classification of the New York Heart Association (NYHA)) or myocardial infarction within 6 months prior to study entry • Corrected QT interval for heart rate (by Bazett connection) (QTcb)> 470 msec • Previous history or presence of another neoplasm other than prostate cancer or squamous cell carcinoma of the treated skin, within the last 5 years • In the opinion of the investigator, any evidence of severe or uncontrolled systemic disease (eg, respiratory, cardiac, hepatic or renal disease currently unstable or decompensated) or evidence of any other significant clinical alteration or laboratory finding that makes it undesirable the patient participates in the study • 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 hemolysis or liver pathology), who will be allowed in consultation with their physician. • Alanine aminotransferase (ALT) or aspartate aminotransferase (AST)> 2.5 times the LSN • Creatinine clearance <50 ml / minute, determined using the Cockcroft-Gault equation or by 24-hour creatinine clearance • Patients who discontinue after randomization can not be enrolled. Patients who do not meet the inclusion / exclusion criteria can be reconsidered once to participate in the study. Patients who are enrolled again must re-consent and will be assigned a new enrollment number • Participation in the programming and conduct of the stu
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Outcome name:Defined as time to death (from randomization) for any cause Measure:Global survival Timepoints:From randomization to death ; Outcome name:Progression is defined as: One or more new bone lesions in bone scintigraphy (confirmed, if there are <3 CT lesions, MRJ or radiography), Development of malignant visceral disease on CT / MRI, Death in the absence of progression Measure:Time to progression compared to placebo Timepoints:When the progression occurs | — |
Secondary
| Measure | Time frame |
|---|---|
| Outcome name:Incidence and severity of adverse events, findings in vital signs, laboratory data, electrocardiogram (ECHO) and physical examination Measure:Safety and tolerability Timepoints:During the study ; Outcome name:Defined as the time to the first PSA value> 50% with respect to the baseline value, observed in at least two consecutive values of PSA Measure:Time to progression of the PSA Timepoints:When the PSA progresses ; Outcome name:As registered by the FWB domain of the FACT-P and the total score of the FACT-P Measure:Functional wellbeing (FWB) Timepoints:During the study ; Outcome name:Defined as time to pain requiring analgesia with opioids due to metastatic disease Measure:Time to symptomatic progression Timepoints:During the study | — |
Countries
Argentina, Australia, Austria, Belgium, Brazil, Canada, Chile, China, Colombia, Czech Republic, Denmark, France, Germany, Hungary, India, Ireland, Israel, Italy, Japan, Korea South, Latovia, Mexico, Netherlands, Norway, Poland, Portugal, Romania, Russian Federation, Spain, Sweden, Taiwan, Turkey, United Kindgdom, United States
Contacts
Public ContactCarmen Tueros
ICON CLINICAL RESEARCH PERU S.A.
Outcome results
None listed