EUCTR2008-002158-40-PT进行中（未招募）不适用
A MULTICENTER, RANDOMIZED, DOUBLE-BLIND, PHASE 3 STUDY OF SUNITINIB PLUS PREDNISONE VERSUS PREDNISONE IN PATIENTS WITH PROGRESSIVE METASTATIC HORMONE-REFRACTORY PROSTATE CANCER AFTER FAILURE OF A DOCETAXEL-BASED CHEMOTHERAPY REGIMEN
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- Pfizer Inc
- 入组人数
- 819
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
- •Subjects must meet all of the following inclusion criteria to be eligible for enrollment into the study:
- •1. Histologically- or cytologically-confirmed adenocarcinoma of the prostate.
- •2. Metastatic hormone-refractory prostate cancer (refractory to androgen ablation). Patients must have surgical or ongoing chemical castration, with baseline testosterone level <50 ng/dL.
- •3. Patients must have disease that has failed one prior docetaxel-based chemotherapy regimen for the treatment of metastatic disease, defined as progression of disease on or after treatment (docetaxel-resistant), or be considered docetaxel-intolerant (discontinued treatment due to unacceptable toxicity, as judged by the treating physician or by the patient). In the event both disease progression and drug intolerance are observed during prior docetaxel-based treatment, disease progression will be considered the dominant entry criterion.
- •4. Patients must have documented evidence of progressive disease defined by either:
- •PSA progression: minimum of 2 rising values (3 measurements) obtained a minimum
- •of one week apart with the last result being at least 2.0 ng/mL,
- •New or increasing non-bone disease (RECIST), or
- •Positive bone scan with 2 or more new lesions (PCWG2).
- •5. ECOG performance status 0 or 1.
- •6. Resolution of all acute toxic effects of prior therapy (except for alopecia and neuropathy) or surgical procedure to grade =1 or to baseline prior to therapy.
- •7. Adequate organ function as defined by the following criteria:
- •Serum aspartate transaminase (AST; serum glutamic oxaloacetic transaminase[SGOT]) and serum alanine transaminase (ALT; serum glutamic pyruvic transaminase [SGPT]) =2.5 x upper limit of normal (ULN), =5 x ULN for patients with liver metastases
- •Total serum bilirubin =1.5 x ULN
- •Absolute neutrophil count (ANC) =1500/µL
- •Platelets =100,000/µL
- •Hemoglobin =9.0 g/dL
- •Serum creatinine =2 x ULN
- •QTc interval =470 msec
- •Left ventricular ejection fraction (LVEF) =lower limit of institutional normal (LLN) as assessed by multigated acquisition (MUGA) scan or echocardiogram (ECHO)
- •8. Signed and dated informed consent document indicating that the patient (or legally acceptable representative) has been informed of all pertinent aspects of the trial prior to enrollment.
- •9. Willingness and ability to comply with scheduled visits, treatment plans, laboratory tests, and other study procedures, including the completion of patient reported outcomes questionnaires and an analgesic use diary.
- •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
- •Subjects presenting with any of the following will not be included in the study:
- •1. Prior treatment with sunitinib (in any clinical setting) and/or more than one prior chemotherapy regimen in the metastatic disease treatment setting.
- •2. Chemotherapy within 3 weeks of the date of the first dose.
- •3. Radioisotope therapy with Strontium-89 or Samarium within 12 weeks of the date of the first dose.
- •4. Radiation therapy (including palliative radiotherapy to metastatic lesion(s)) within 2 weeks or major surgery (e.g., open abdominal, pelvic, thoracic, orthopedic or neurosurgery) within 4 weeks of the date of the first dose.
- •5. Current treatment on another therapeutic clinical trial.
- •6. Impending complication from bone metastases (fracture and/or cord compression).
- •Properly treated or stabilized fractures and/or cord compression is allowed.
- •7. Presence of ongoing urinary obstruction (e.g., urinary retention, hydronephrosis) requiring medical intervention. Properly treated urinary obstruction is allowed.
- •8. Grade =3 hemorrhage within 4 weeks of the date of the first dose.
- •9. Ongoing cardiac dysrhythmias of grade =2.
- •10. Hypertension that cannot be controlled by medications (>150/100 mmHg despite optimal medical therapy)
- •11. Ongoing treatment with therapeutic doses (with therapeutic INR levels) of coumarinderivatives or oral anti-vitamin K agents.
- •12. Diagnosis of any second malignancy within the last 3 years, except basal cell carcinoma, squamous cell skin cancer, stage I carcinoma fully treated, or in situ carcinoma that have been adequately treated with no evidence of recurrent disease for 12 months.
- •13. Any of the following within the 6 months prior to study drug administration: severe/unstable angina, myocardial infarction, symptomatic congestive heart failure,
- •pulmonary embolism, cerebrovascular accident, or transient ischemic attack.
- •14. History of, or known brain metastases (skull metastases allowed), carcinomatous
- •meningitis, or leptomeningeal disease.
- •15. Known human immunodeficiency virus (HIV) infection.
- •16. Other severe acute or chronic medical or psychiatric condition, or laboratory abnormality that would impart, in the judgment of the investigator, excess risk associated with study participation or study drug administration, or which, in the judgment of the investigator would make the patient inappropriate for entry into the trial.
研究者
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