A Multinational Phase 3, Randomized, Double-Blind, Placebo-Controlled Efficacy and SafetyStudy of Oral MDV3100 in Chemotherapy-Na?ve Patients with Progressive Metastatic Prostate CancerWho Have Failed Androgen Deprivation Therapy - PREVAI
- Conditions
- Chemotherapy-Na?ve Patients with Progressive Metastatic Prostate Cancer Who Have Failed Androgen Deprivation TherapyMedDRA version: 9.1Level: LLTClassification code 10036909
- Registration Number
- EUCTR2010-020821-41-IT
- Lead Sponsor
- Medivation, Inc.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- Male
- Target Recruitment
- 1717
1. Willing and able to provide informed consent;
2. Histologically or cytologically confirmed adenocarcinoma of the prostate without neuroendocrine
differentiation or small cell features;
3. Ongoing androgen deprivation therapy with a GnRH analogue or bilateral orchiectomy (i.e., surgical or
medical castration);
4. Patients who have not had a bilateral orchiectomy, must have a plan to maintain effective GnRH-analogue
therapy for the duration of the trial;
5. Serum testosterone level = 1.73 nmol/L (50 ng/dL) at the Screening visit;
6. Patients receiving bisphosphonate therapy must have been on stable doses for at least 4 weeks;
7. Progressive disease at study entry defined as one or more of the following three criteria that occurred while the
patient was on androgen deprivation therapy as defined in eligibility criterion #2:
• PSA progression defined by a minimum of two rising PSA levels with an interval of = 1 week between each
determination. Patients who received an anti-androgen must have progression after withdrawal (= 4 weeks since
last flutamide or = 6 weeks since last bicalutamide or nilutamide). The PSA value at the Screening visit should
be = 2 µg/L (2 ng/mL);
• Soft tissue disease progression defined by RECIST 1.1;
• Bone disease progression defined by PCWG2 with two or more new lesions on bone scan;
8. Metastatic disease documented by bone lesions on bone scan or by measurable soft tissue disease by CT/MRI. Patients whose disease spread is limited to regional pelvic lymph nodes are not eligible;
9. No prior cytotoxic chemotherapy for prostate cancer;
10. Asymptomatic or mildly symptomatic from prostate cancer (i.e., the score on Brief Pain Inventory – Short
Form Question #3 must be < 4);
11. Eastern Cooperative Oncology Group (ECOG) performance status of 0–1;
12. Estimated life expectancy of = 6 months;
13. Able to swallow the study drug and comply with study requirements.
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
1. Severe concurrent disease,infection, or co-morbidity that, in the judgment of the Investigator, would make the
patient inappropriate for enrollment;
2. Known or suspected brain metastasis or active leptomeningeal disease;
3. History of another malignancy within the previous 5 years other than curatively treated non-melanomatous
skin cancer;
4. Absolute neutrophil count <1,500/µL, or platelet count <100,000/µL, or hemoglobin <5.6 mmol/L (9 g/dL) at the Screening visit (NOTE: patients may not have received any growth factors within 7 days or blood transfusions within 28 days of the hematologic laboratory values obtained at the Screening visit);
5. Total bilirubin, alanine aminotransferase (ALT) or aspartate aminotransferase (AST) >2.5 times the ULN at the Screening visit;
6. Creatinine >177 µmol/L (2mg/dL) at the Screening visit;
7. Albumin <30 g/L (3.0 g/dL) at the Screening visit;
8. History of seizure or any condition that may predispose to seizure. Also, history of loss of consciousness or
transient ischemic attack within 12 months of enrollment (Day 1 visit);
9. Clinically significant cardiovascular disease including:
• Myocardial infarction within 6 months;
• Uncontrolled angina within 3 months;
• NYHA class 3 or 4, or patients with history of congestive heart failure NYHA class 3 or 4 in the past, unless a screening echocardiogram or multi-gated
acquisition scan performed within three months results in a left ventricular ejection fraction that is =45%;
• History of clinically significant ventricular arrhythmias (e.g., ventricular tachycardia, ventricular fibrillation, torsades de pointes);
• History of Mobitz II second degree or third degree heart block without a permanent pacemaker in place;
• Hypotension as indicated by systolic blood pressure <86 millimeters of mercury (mmHg) at the Screening visit;
• Bradycardia as indicated by a heart rate of <50 beats per minute on the Screening ECG;
• Uncontrolled hypertension as indicated by systolic blood pressure >170 mmHg or diastolic blood pressure >105 mmHg at the Screening visit;
10. Gastrointestinal disorder affecting absorption (e.g., gastrectomy, active peptic ulcer disease within last 3
months);
11. Major surgery within 4 weeks of enrollment (Day 1 Visit);
12. Use of opiate analgesics for pain from prostate cancer within 4 weeks of enrollment (Day 1 visit);
13. Radiation therapy for treatment of the primary tumor within 3 weeks of enrollment (Day 1 visit);
14. Radiation or radionuclide therapy for treatment of metastasis;
15. Treatment with flutamide within 4 weeks of enrollment (Day 1 visit);
16. Treatment with bicalutamide or nilutamide within 6 weeks of enrollment (Day 1 visit);
17. Treatment with 5-a reductase inhibitors (finasteride, dutasteride), estrogens, cytproterone within 4 weeks of enrollment (Day 1 visit)
18. Treatment with systemic biologic therapy for prostate cancer (other than approved bone targeted agents and
GnRH-analogue therapy) or other agents with anti-tumor activity within 4 weeks of enrollment (Day 1 visit);
19. History of prostate cancer progression on ketoconazole;
20. Prior use, or participation in a clinical trial, of an investigational agent that blocks androgen synthesis (e.g.,abiraterone acetate, TAK-700, TAK-683, TAK-448) or targets the androgen receptor (e.g., BMS 641988);
21. Participation in a previous clinical trial of MDV3100;
22. Use of an investigational agent within 4 weeks of enrollment (Day 1 visit);
23. Use of herbal products that ma
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method