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

Bayer

Status and phase: Completed; Phase 1

Conditions: Prostatic Neoplasms

Treatments: Drug: Radium-223 dichloride (Xofigo, BAY88-8223)

Study type: Interventional

Funder types: Industry

Identifiers

NCT01565746

15354

Details and patient eligibility

About

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.

Enrollment: 19 patients

Sex: Male

Ages: 20+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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19 participants in 3 patient groups

Radium-223 dichloride [50 kBq/kg]

Experimental group

Treatment:

Drug: Radium-223 dichloride (Xofigo, BAY88-8223)

Drug: Radium-223 dichloride (Xofigo, BAY88-8223)

Drug: Radium-223 dichloride (Xofigo, BAY88-8223)

Radium-223 dichloride [100 kBq/kg]

Experimental group

Treatment:

Drug: Radium-223 dichloride (Xofigo, BAY88-8223)

Drug: Radium-223 dichloride (Xofigo, BAY88-8223)

Drug: Radium-223 dichloride (Xofigo, BAY88-8223)

Radium-223 dichloride [expansion]

Experimental group

Treatment:

Drug: Radium-223 dichloride (Xofigo, BAY88-8223)

Drug: Radium-223 dichloride (Xofigo, BAY88-8223)

Drug: Radium-223 dichloride (Xofigo, BAY88-8223)