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

NCT ID: NCT01565746

Last Updated: 2016-10-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

19 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-03-31

Study Completion Date

2016-04-30

Brief Summary

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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.

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Detailed Description

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Conditions

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Prostatic Neoplasms

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Radium-223 dichloride [50 kBq/kg]

Group Type EXPERIMENTAL

Radium-223 dichloride (Xofigo, BAY88-8223)

Intervention Type DRUG

Radium-223 dichloride (Xofigo, BAY88-8223) 50 kBq/kg

Radium-223 dichloride [100 kBq/kg]

Group Type EXPERIMENTAL

Radium-223 dichloride (Xofigo, BAY88-8223)

Intervention Type DRUG

Radium-223 dichloride (Xofigo, BAY88-8223) 100 kBq/kg

Radium-223 dichloride [expansion]

Group Type EXPERIMENTAL

Radium-223 dichloride (Xofigo, BAY88-8223)

Intervention Type DRUG

Expansion arm: Radium-223 dichloride (Xofigo, BAY88-8223) 50 kBq/kg

Interventions

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Radium-223 dichloride (Xofigo, BAY88-8223)

Radium-223 dichloride (Xofigo, BAY88-8223) 50 kBq/kg

Intervention Type DRUG

Radium-223 dichloride (Xofigo, BAY88-8223)

Radium-223 dichloride (Xofigo, BAY88-8223) 100 kBq/kg

Intervention Type DRUG

Radium-223 dichloride (Xofigo, BAY88-8223)

Expansion arm: Radium-223 dichloride (Xofigo, BAY88-8223) 50 kBq/kg

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

20 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No

Sponsors

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Bayer

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Bayer Study Director

Role: STUDY_DIRECTOR

Bayer

Locations

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Kashiwa, Chiba, Japan

Site Status

Yokohama, Kanagawa, Japan

Site Status

Sayama, Osaka, Japan

Site Status

Countries

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Japan

References

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Yoshida K, Kaneta T, Takano S, Sugiura M, Kawano T, Hino A, Yamamoto T, Shizukuishi K, Kaneko M, Zurth C, Inoue T. Pharmacokinetics of single dose radium-223 dichloride (BAY 88-8223) in Japanese patients with castration-resistant prostate cancer and bone metastases. Ann Nucl Med. 2016 Aug;30(7):453-60. doi: 10.1007/s12149-016-1093-8. Epub 2016 Jun 7.

Reference Type RESULT
PMID: 27272279 (View on PubMed)

Uemura H, Uemura H, Matsubara N, Kinuya S, Hosono M, Yajima Y, Doi T. Safety and efficacy of radium-223 dichloride in Japanese patients with castration-resistant prostate cancer and bone metastases. Int J Clin Oncol. 2017 Oct;22(5):954-963. doi: 10.1007/s10147-017-1130-1. Epub 2017 May 6.

Reference Type DERIVED
PMID: 28478485 (View on PubMed)

Other Identifiers

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15354

Identifier Type: -

Identifier Source: org_study_id

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