Prostatic Neoplasms
Conditions
Keywords
BAY88-8223, radium-223 dichloride, prostate cancer
Brief summary
This is an uncontrolled, open-label, non-randomized Phase I study to investigate safety, biodistribution, radiation dosimetry and pharmacokinetics of a single dose of BAY88-8223 in Japanese patients with castration-resistant prostate cancer and bone metastases.
Interventions
DRUGRadium-223 dichloride (Xofigo, BAY88-8223)
Radium-223 dichloride (Xofigo, BAY88-8223) 50 kBq/kg
Sponsors
Bayer
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
20 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Male ≥ 20 years of age * Histologically or cytologically confirmed adenocarcinoma of the prostate * Presents with at least 2 bone metastases, confirmed by scintigraphic imaging within the previous 4 weeks * Patients who has failed initial hormonal therapy using either an orchiectomy or a Gonadotropin releasing hormone (GnRH) agonist in combination with an antiandrogen must first progress through antiandrogen withdrawal prior to being eligible. The minimum timeframe to document failure of anti-androgen withdrawal will be four weeks * Progressive castration resistant metastatic disease * Castrate level of testosterone (\<50 ng/dL), treatment to maintain castrate levels of testosterone must be continued
Exclusion criteria
* Has received an investigational drug in the 4 weeks before or is scheduled to receiving one during or in the 8 weeks after study drug administration. * Has received chemo-, immuno-, or radiotherapy within the last 4 weeks prior to entry in the study, or has not recovered from acute adverse events as a result of such therapy * Has received prior hemibody external radiotherapy * Has a need for immediate external radiotherapy * Has received systemic radiotherapy with radium-223, strontium-89, samarium-153, rhenium-186 or rhenium-188 for the treatment of bony metastases within the last 24 weeks prior to administration of study drug * When receiving bisphosphonates, has changed the dose within 4 weeks before administration of study drug
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Maximum drug concentration in blood after single dose administration (Cmax) of BAY88-8223 for blood samples | up to 72 hours | — |
| Area under the concentration - time curve (AUC) of BAY88-8223 for blood samples | up to 72 hours | — |
| Number of participants with Critical toxicities | Up to day 28 | Critical toxicities (using National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) version 4.0) will be defined as the occurrence of one or more of the following drug-related toxicities: 1) ≥Grade 3 non-hematologic toxicity, 2) Grade 3 neutropenia with fever, 3) Grade 4 neutropenia that failed to recover to grade 2 or less after treatment with Granulocyte colony-stimulating factor (GCSF) within 2 weeks, 4) Grade 4 thrombocytopenia |
Secondary
| Measure | Time frame |
|---|---|
| Changes in prostate specific antigen (PSA) | baseline, up to 12 weeks |
| Overall Survival | Up to 36 months |
Countries
Japan
Outcome results
None listed