EUCTR2009-013174-41-IT进行中（未招募）1 期
AFFIRM: A Multinational Phase 3, Randomized, Double-Blind, Placebo-Controlled Efficacy and Safety Study of Oral MDV3100 in Patients with Progressive Castration-Resistant Prostate Cancer Previously Treated with Docetaxel-Based Chemotherapy - AFFIRM
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 1,170
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. Histologically or cytologically confirmed adenocarcinoma of the prostate without neuroendocrine differentiation or small cell features; 2. Ongoing androgen deprivation therapy with a gonadotropin releasing hormone (GnRH) analogue or orchiectomy (i.e., surgical or medical castration); 3. For patients who have not had an orchiectomy, there must be a plan to maintain effective GnRH-analogue therapy for the duration of the trial; 4. Serum testosterone level < 1.7 nmol/L (50 ng/dL) at the Screening visit; 5. Patients receiving bisphosphonate therapy must have been on stable doses for at least four weeks; 6. Progressive disease by PSA or imaging after docetaxel-based chemotherapy in the setting of medical or surgical castration. Disease progression for study entry is defined as one or more of the following three criteria: PSA progression defined by a minimum of three rising PSA levels with an interval of ≥ 1 week between each determination. The PSA value at the Screening visit should be ≥ 2 ?g/L (2 ng/mL); Soft tissue disease progression defined by RECIST (Appendix A); Bone disease progression defined by two or more new lesions on bone scan; 7. No more than two prior chemotherapy regimens with at least one regimen containing docetaxel; 8. ECOG performance status of 0 2; 9. Estimated life expectancy of ≥ six months; 10. Able to swallow the study drug and comply with study requirements; 11. Willing and able to give informed consent.
- •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. Severe concurrent disease, infection, or co-morbidity that, in the judgment of the investigator, would make the patient inappropriate for enrollment; 2. Metastases in the brain or active epidural disease (NOTE: patients with treated epidural disease are allowed); 3. Absolute neutrophil count < 1,500/?L, platelet count < 100,000/?L, and hemoglobin < 5.6 mmol/L (9 g/dL) at the Screening visit; (NOTE: patients may not have received any growth factors or blood transfusions within seven days of the hematologic laboratory values obtained at the Screening visit); 4. Total bilirubin, alanine aminotransferase (ALT) or aspartate aminotransferase (AST) > 2 times the upper limit of normal at the Screening visit; 5. Creatinine > 177 ?mol/L (2 mg/dL) at the Screening visit; 6. Albumin < 30 g/L (3.0 g/dL) at the Screening visit; 7. History of another malignancy within the previous 5 years other than curatively treated non-melanomatous skin cancer; 8. Treatment with androgen receptor antagonists (bicalutamide, flutamide, nilutamide), 5-α reductase inhibitors (finasteride, dutasteride), estrogens, or chemotherapy within four weeks of enrollment (Day 1 visit) or plans to initiate treatment with any of these treatments during the study; 9. Treatment with therapeutic immunizations for prostate cancer (e.g., PROVENGE) or plans to initiate treatment with any of these treatments during the study; 10. Use of herbal products that may decrease PSA levels (e.g., saw palmetto) or systemic corticosteroids greater than the equivalent of 10 mg of prednisone/prednisolone per day within four weeks of enrollment (Day 1 visit) or plans to initiate treatment with any of these treatments during the study; 11. History of prostate cancer progression on ketoconazole or plans to initiate ketoconazole treatment during the study; 12. Radiation therapy within 3 weeks (if single fraction of radiotherapy within 2 weeks) and radionuclide therapy within 8 weeks of enrollment (Day 1 visit); 13. Planned palliative procedures for alleviation of bone pain such as radiation therapy or surgery; 14. Structurally unstable bone lesions suggesting impending fracture; 15. History of seizure, including any febrile seizure, loss of consciousness, or transient ischemic attack within 12 months of enrollment (Day 1 visit), or any condition that may pre-dispose to seizure (e.g., prior stroke, brain arteriovenous malformation, head trauma with loss of consciousness requiring hospitalization)
研究者
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