EUCTR2009-013174-41-FR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 µg/L (2 ng/mL);
- •Soft tissue disease progression defined by RECIST 1.1 (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 = 6 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/µL, platelet count < 100,000/µL, 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 7 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 µmol/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-a 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);
- •16. Clinically significant cardiovascular disease;
- •17. Have used or plan to use from 30 days prior to enrollment (Day 1 visit) through the end of the study medications known to lower the seizure threshold or prolong the QT interval;
- •Aminophylline/theophylline;
- •Atypical antipsychotics (e.g., clozapine, olanzapine, risperidone, ziprasidone);
- •Bupropion;
- •Class IA and III antiarrhythmics (e.g., amiodarone, bretylium, disopyramide, ibutilide, procainamide, quinidine, sotalol);
- •Dolasetron;
- •Droperidol;
- •Gatafloxacin/moxifloxacin;
- •Macrolide antibiotics (e.g., erythromycin, clarithromycin);
- •Pethidine;
- •Phenothiazine antipsychotics (e.g., chlorpromazine, mesoridazine, thioridazine);
- •Pimozide;
- •Tricyclic and tetracyclic antidepressants (e.g., amitriptyline, desipramine, doxepin, imipramine, maprotiline, mirtazapine);
- •Venlafaxine.
- •18. Participation in a previous clinical trial of an investigational agent that blocks androgen synthesis (e.g., abiraterone acetate, TAK-700, TAK-68
研究者
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