EUCTR2007-003228-39-FI进行中（未招募）不适用
A Phase III, Randomised, Double-blind, Placebo-controlled Study to Assess the Efficacy and Safety of 10 mg ZD4054 in Combination with Docetaxel in Comparison with Docetaxel in Patients with Metastatic Hormone-resistant Prostate Cancer
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 1,044
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- Male
入选标准
- •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 scan. Patients must have disease involvement <75% of the spine, pelvis and ribs in the anteroposterior (AP) or posteroanterior (PA) view. Patients with =3 lesions seen on bone scan will require a CT scan, MRI or x-ray to confirm
- •5.Biochemical progression of prostate cancer, defined as at least 2 stepwise increases in a series of any 3 PSA values collected while the patient is castrate. The 3 PSA values selected do not need to be consecutive, and do not need to include the most recent PSA collected at or prior to study enrolment but must meet the following criteria:
- •- There must be at least 14 days between each of the 3 PSA values, and each must be collected no more than 1 year before enrolment into the study
- •- The last PSA value in the series of 3 must be either an increase of =25% of the first PSA or an absolute increase of =10ng/nL over the first PSA
- •- The last PSA value in the series of 3 must be=1.2 ng/mL in patients who have had radical prostatectomy and =5ng/mL in all other patients
- •- Each of the 3 PSA values must be collected whilst the patient is under medical castration or is surgically castrated
- •6.Continuosely medically castrated with stable treatment for at least 8 weeks prior to study randomisation or sugically castrated. Acceptable medical castration includes luteinising hormone-releasing hormone analogues (LHRHa), estradiol, estramustine or other estrogen based preparations. Anti-androgens can be taken in conjunction with medical castration. Serum testosteron must be =2.4mmol/L (70ng/dL) at enrolment despite method of castration.
- •7.World Health Organisation (WHO) performance status 0 – 1 (see Appendix E).
- •8.Life expectancy of 3 months or more.
- •For inclusion in the genetic component of the study, patients must fulfil the following criterion:
- •1.Provision of informed consent for genetic research.
- •If a patient declines to participate in the genetic research, there will be no penalty or loss of benefit to the patient. The patient will not be excluded from other aspects of the study described in this Clinical Study Protocol, so long as they consent to participate
- •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
排除标准
- •1.Radiotherapy to bone lesion or prostatic bed within 4 weeks of starting study treatment
- •2.Prior cytotoxic chemotherapy (eg paclitaxel, docetaxel, mitoxantrone) for the treatment of recurrent prostate cancer (prior estramustine therapy is allowed).
- •Prior targeted cancer therapies eg EGF, EGFR, VEGF and VEGFR or immune cell therapy, only permitted if the patient received them during participation in a previous clinical trial
- •3.Systemic radionuclide therapy (ie, strontium chloride Sr89, 186Relabeled HEDP, or 153Sm-EDTMP pentasodium) within 12 weeks of starting study treatment
- •4.Use of potent CYP450 inducers (eg phenytoin, rifampicin, carbamazepine, phenobarbitone, St John’s Wort) within 2 w of starting study treatment. Dexamethasone is acceptable for this study when used as part of the standard docetaxel regime
- •5.Use of systemic retinoids within 2 w of starting study treatment
- •6.Have received investigational drug in another clinical study of anti-cancer therapy, within 4 w of starting study treatment
- •7.Prior therapy with endothelin receptor antagonists or family history of hypersensitivity to endothelin antagonists
- •8.Acute or evolving spinal cord compression, neurological symptoms or signs consistent with this. 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
- •9.Symptomatic peripheral neuropathy of CTCAE grade 2 or higher
- •10.Known or suspected central nervous system metastases
- •11.History of past or current epilepsy, epilepsy syndrome, or other seizure disorder
- •12.Stage II, III or IV cardiac failure (classified according to NYHA) or myocardial infarction within 6 months prior to study entry
- •13.QT interval corrected for heart rate eg, by Bazett’s correction >470 msec
- •14.Previous history or presence of another malignancy within the preceding 5 y except treated squamous/basal cell carcinoma of the skin or melanoma that has been fully excised with no signs of residual disease or recurrence at the time of study enrolment
- •15.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
- •16.Absolute Neutrophil Count (ANC) <1.5 x 109/L (1,500/mm3); haemoglobin (Hb) <9 g/dL; platelet count <100 x 109/L (100,000/mm3). Concomitant use of erythropoietin or blood transfusions is allowed
- •17.Serum bilirubin >1.5 times the upper limit of normal (ULN). Not applicable to patients with confirmed 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
- •18.Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) >2.5 times the ULN or 5 times the ULN in the presence of liver metastases
- •19.Creatinine clearance of <50 mL/minute, determined using the Cockcroft-Gault equation or by 24-hour creatinine clearance
- •20.Patients who have been previously randomised in this study cannot be rerandomised. Patients who fail to meet the exclusion/inclusion criteria may be reconsidered once for participation in the study
- •21.Involvement in the planning and conduct of the study (staff at ICON, Ast
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