Clinical trial NCT01565746: Safety, Biodistribution, Radiation Dosimetry and Pharmacokinetics Study of BAY88-8223 in Japanese Patients
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Prostatic Neoplasms
Keywords: BAY88-8223
radium-223 dichloride
prostate cancer
Lead sponsor: Bayer
Sponsor class: INDUSTRY
First posted: 2012-03-29
Enrollment: 19
Sex: MALE
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: 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

Primary outcomes:
measure: Number of participants with Critical toxicities
timeFrame: Up to day 28
measure: Maximum drug concentration in blood after single dose administration (Cmax) of BAY88-8223 for blood samples
timeFrame: up to 72 hours
measure: Area under the concentration - time curve (AUC) of BAY88-8223 for blood samples
timeFrame: up to 72 hours
Secondary outcomes:
measure: Changes in prostate specific antigen (PSA)
timeFrame: baseline, up to 12 weeks
measure: Overall Survival
timeFrame: Up to 36 months
Other outcomes:
Locations:
city: Kashiwa
country: Japan
state: Chiba
city: Yokohama
country: Japan
state: Kanagawa
city: Osakasayama
country: Japan
state: Osaka
Study officials:
affiliation: Bayer
name: Bayer Study Director
role: STUDY_DIRECTOR
References:
citation: 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.
citation: 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.