Japanese BAY88-8223 Monotherapy Phase II Study

• Status: Completed
• Trial end date: 2017-05-16
• Target enrollment: 0
• Participant gender: Male

Summary

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

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

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

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