Trial Condition(s):
Safety, biodistribution, radiation dosimetry and pharmacokinetics study of BAY88-8223 in Japanese patients
15354
Not Available
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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.
- 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
- 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
Locations | Status | |
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Locations Investigative Site Kashiwa, Japan, 277-8577 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Yokohama, Japan, 236-0004 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Osakasayama, Japan, 589-8511 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
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
Trial Type:
Interventional
Intervention Type:
Drug
Trial Purpose:
Treatment
Allocation:
Non-randomized
Blinding:
Open Label
Assignment:
Parallel Assignment
Trial Arms:
3