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Completed

NCT Number: NCT01929655

Japanese BAY88-8223 Monotherapy Phase II Study

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

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Key information

Conditions

Prostatic Neoplasms Genital Diseases Genital Diseases, Male Genital Neoplasms, Male Male Urogenital Diseases Neoplasms Neoplasms by Site Prostatic Diseases Urogenital Diseases Urogenital Neoplasms

Age range

20 year and older

Sex eligibility

Male

Study type

Interventional

Phase

Phase 2

Primary location

Kashiwa, Chiba, Japan

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Radium-223 dichloride (Xofigo, BAY88-8223)

Drug

BAY88-8223, 50 kBq/kg will be administered as slow bolus intravenous injection 6 times at intervals of 4 weeks between each administration

Primary outcomes

  1. Percentage of change in total alkaline phosphatase from baseline at 12 weeks

    Time frame: Baseline and 12 weeks

Secondary outcomes

  1. Percentage of change in total alkaline phosphatase at the end of treatment

    Time frame: Baseline and 24 weeks

  2. Percentages of change in bone ALP at 12 weeks

    Time frame: Baseline and 12 weeks

  3. Percentages of change in bone ALP at the end of treatment

    Time frame: Baseline and 24 weeks

  4. The proportion of subjects who have total alkaline phosphatase normalization at 12 weeks

    Time frame: 12 weeks

  5. The proportion of subjects who have total alkaline phosphatase normalization at the end of treatment

    Time frame: 24 weeks

  6. The proportion of subjects who have bone alkaline phosphatase normalization at 12 weeks

    Time frame: 12 weeks

  7. The proportion of subjects who have bone alkaline phosphatase normalization at the end of treatment

    Time frame: 24 weeks

  8. Time to prostate specific antigen progression

    Time frame: 24 weeks

  9. Overall survival

    Time frame: 3 years

  10. Percentages of change in biomarkers of bone turnover at each time point

    Time frame: Baseline and 36 weeks

  11. Number of participants with drug related adverse events and serious adverse events as a measure of safety and tolerability

    Time frame: 3 years

  12. Incidence of treatment-emergent adverse events (TEAEs)

    Time frame: 24 weeks plus 30 days

  13. Number of participants with abnormal laboratory values

    Time frame: 36 weeks

Sponsors and collaborators

Lead sponsor

Bayer

Industry

Registry information

Official study title

A Single-arm, Open-label, Multicenter, Phase II Study of BAY88-8223 in the Treatment of Japanese Patients With Symptomatic Castration-resistant Prostate Cancer (CRPC) With Bone Metastases

Important dates

Study start
2013
Primary completion
2017
Study completion
2017
First posted
Aug 28, 2013
Registry last updated
Apr 24, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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