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Japanese BAY88-8223 Monotherapy Phase II Study

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Bayer

Status and phase

Completed
Phase 2

Conditions

Prostatic Neoplasms

Treatments

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

Study type

Interventional

Funder types

Industry

Identifiers

Details and patient eligibility

About

To evaluate the efficacy and safety of the best standard of care plus BAY88-8223 in Japanese patients with CRPC and bone metastases after a multiple administration

Enrollment

49 patients

Sex

Male

Ages

20+ years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria:

  • Have received docetaxel or not eligible for the first course of docetaxel, i.e. patients who are not fit enough and willing.
  • Histologically or cytologically confirmed adenocarcinoma of the prostate
  • Multiple bone metastases
  • Either regular (not occasional) analgesic medication use for cancer-related bone pain or treatment with external beam radiotherapy (EBRT) for bone pain.
  • Best standard of care(BSoC) is regarded as the routine standard of care.

Exclusion Criteria :

  • Treatment with cytotoxic chemotherapy within previous 4 weeks, or planned during the treatment period
  • History of visceral metastasis, or presence of visceral metastasis

Trial design

Primary purpose

Treatment

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

49 participants in 1 patient group

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

Trial contacts and locations

16

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Data sourced from clinicaltrials.gov

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