Safety, Biodistribution, Radiation Dosimetry and Pharmacokinetics Study of BAY88-8223 in Japanese Patients

• Status: Completed
• Trial end date: 2016-04-01
• Target enrollment: 0
• Participant gender: Male

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Bayer
• Treatments: Radium Ra 223 dichloride; Succinylcholine

Criteria

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