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

Phase 1

• Conditions: Progressive Castration-Resistant Prostate Cancer; MedDRA version: 12.0Level: LLTClassification code 10007385Term: Carcinoma in situ of prostate

• Registration Number: EUCTR2009-013174-41-IT
• Lead Sponsor: Medivation, Inc.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2009-11-03
• Last Update Posted: 19 February 2018

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Male
• Target Recruitment: 1170

Inclusion Criteria

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

Exclusion Criteria

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)

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified