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Radium-223 Dichloride in Castration-Resistant (Hormone-Refractory) Prostate Cancer Patients With Bone Metastases—Expanded Access Program1
Expanded Access Program Trial Design • Population: Patients diagnosed with castrate-resistant (hormone-refractory) prostate cancer and bone metastases
Expanded Access Program for Radium-223 Dichloride TREATMENT PHASE
FOLLOW-UP PHASE
6 injections at 4-week intervals
Assessments every 6 months until end of program
Radium-223 Dichloride* 50 kBq/kg
M0
M6
M12
M18
M24
MONTHS *Plus best standard of care.
Purpose • To provide Radium-223 Dichloride to CRPC/HRPC patients diagnosed with bone metastases • To collect short- and long-term safety data on Radium-223 Dichloride
Inclusion Criteria†:
Exclusion Criteria†:
• Age≥18 years • Histologically or cytologically confirmed prostate cancer • Patients diagnosed with progressive bone predominant metastatic CRPC/HRPC with at least 2 skeletal metastases on bone scan with no lung, liver, and/or brain metastasis (lymph-node-only metastasis is allowed) • Progressive disease is defined either by: – The appearance of new bone lesions. If progression is based on new lesion(s) on bone scan only without an increase in PSA, PSA values from 3 assessments within the last 6 months must be provided; OR – In the absence of new bone lesions by 2 consecutive increases in serum PSA over previous reference value, which should not be more than 6 months before screening, each measured at least 1 week apart with the last PSA ≥5 ng/mL • Life expectancy ≥6 months • ECOG PS of 0 to 2 • Adequate hematological, liver, and renal function – ANC ≥1.5 x109/L – Platelet count ≥100 x109/L – Hemoglobin ≥10.0 g/dL (100 g/L; 6.2 mmol/L) – Total bilirubin level ≤1.5 x institutional ULN – AST and ALT ≤2.5 x ULN – Creatinine ≤1.5 x ULN – Albumin >25 g/L
• Treatment with an investigational drug within previous 4 weeks, or planned during the treatment period or follow-up • Eligible for first course of docetaxel (ie, patients who are fit enough, willing, and who are located where treatment with docetaxel is available) • Treatment with cytotoxic chemotherapy within previous 4 weeks, or failure to recover from AEs due to cytotoxic chemotherapy administered more than 4 weeks previous (however, ongoing neuropathy is permitted) • Received previous radiotherapy to >25% of bone marrow, including hemibody radiation • Received systemic therapy with radionuclides (eg, strontium-89, samarium-153, rhenium-186, or rhenium-188, or radium-223 chloride) for the treatment of bony metastases • Other malignancy treated within the last 3 years (except nonmelanoma skin cancer or low-grade superficial bladder cancer) • Visceral metastases as assessed by abdominal or pelvic CT (or other imaging modality) • Presence of brain metastases • Lymphadenopathy exceeding 6 cm in short-axis diameter • Any size pelvic lymphadenopathy if it is thought to be a contributor to concurrent hydronephrosis • Imminent or history of spinal cord compression based on clinical findings and/or MRI • Any other serious illness or medical condition, such as but not limited to: – Any infection ≥NCI-CTCAE version 4.03 Grade 2 – Cardiac failure NYHA III or IV – Crohn’s disease or ulcerative colitis – Bone marrow dysplasia • Fecal incontinence
Radium-223 Dichloride is an investigational agent and is not approved by the US Food and Drug Administration, the European Medicines Agency, or other health authorities. Additional criteria apply.
†
Reference: 1. Bayer HealthCare Clinical Study Protocol BAY 88-8223/16216. Version 1.0; January 25, 2012. Abbreviation: CRPC=castration-resistant prostate cancer; HRPC=hormone-refractory prostate cancer; EBRT=external beam radiation therapy; PSA=prostate-specific antigen; ECOG PS=Eastern Cooperative Oncology Group Performance Status; ANC=absolute neutrophil count; ULN=upper limit of normal; AST=aspartate aminotransferase; ALT=alanine aminotransferase; AEs=adverse events; CT=computed tomography; MRI=magnetic resonance imaging; NCI-CTCAE=National Cancer Institute Common Terminology Criteria for Adverse Events; NYHA=New York Heart Association
Bayer Pharma AG 13342 Berlin, Germany www.bayerpharma.com
G.SM.ON.06.2012.0419
04/12