Study Completed

Prostatic Neoplasms

Bayer Identifier:

15354

ClinicalTrials.gov Identifier:

NCT01565746

EudraCT Number:

Not Available

EU CT Number:

Not Available

Safety, biodistribution, radiation dosimetry and pharmacokinetics study of BAY88-8223 in Japanese patients

Trial purpose

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.

Key Participants Requirements

Sex

Male

Age

20 - N/A

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 summary

Enrollment Goal

Trial Dates

March 2012 - April 2016

Phase

Phase 1

Could I Receive a placebo

Products

Xofigo (Radium-223 dichloride, BAY88-8223)

Accepts Healthy Volunteer

Where to participate

Status	Institution	Location
Completed		Kashiwa, 277-8577, Japan
Completed		Yokohama, 236-0004, Japan
Completed		Osakasayama, 589-8511, Japan

Primary Outcome

Number of participants with Critical toxicities
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
Time Frame:
Up to day 28
Safety Issue:
Yes
Maximum drug concentration in blood after single dose administration (Cmax) of BAY88-8223 for blood samples
Time Frame:
up to 72 hours
Safety Issue:
No
Area under the concentration - time curve (AUC) of BAY88-8223 for blood samples
Time Frame:
up to 72 hours
Safety Issue:
No

Secondary Outcome

Changes in prostate specific antigen (PSA)
Time Frame:
baseline, up to 12 weeks
Safety Issue:
No
Overall Survival
Time Frame:
Up to 36 months
Safety Issue:
No

Trial design

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

Additional Information

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