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

NCT01565746 | Completed Phase 1

• 1 other identifier: 15354
• Study Type: interventional
• Target: 19
• Locations: 1 country
• Sites: 3

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.

Conditions

Prostatic Neoplasms

Keywords

BAY88-8223; radium-223 dichloride; prostate cancer

Outcome Measures

Primary Outcomes (3)

• Number of participants with Critical toxicities

  Critical toxicities (using National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) version 4.0) will be defined as the occurrence of one or more of the following drug-related toxicities: 1) ≥Grade 3 non-hematologic toxicity, 2) Grade 3 neutropenia with fever, 3) Grade 4 neutropenia that failed to recover to grade 2 or less after treatment with Granulocyte colony-stimulating factor (GCSF) within 2 weeks, 4) Grade 4 thrombocytopenia

  Up to day 28

• Maximum drug concentration in blood after single dose administration (Cmax) of BAY88-8223 for blood samples

  up to 72 hours

• Area under the concentration - time curve (AUC) of BAY88-8223 for blood samples

  up to 72 hours

Secondary Outcomes (2)

• Changes in prostate specific antigen (PSA)

  baseline, up to 12 weeks

• Overall Survival

  Up to 36 months

Study Arms (3)

Radium-223 dichloride [50 kBq/kg]

EXPERIMENTAL

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

Radium-223 dichloride [100 kBq/kg]

EXPERIMENTAL

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

Radium-223 dichloride [expansion]

EXPERIMENTAL

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

Interventions

Radium-223 dichloride (Xofigo, BAY88-8223) DRUG

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

Radium-223 dichloride [50 kBq/kg]

Eligibility Criteria

• Age: 20 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Bayer: lead

Study Sites (3)

Unknown Facility

Kashiwa, Chiba, 277-8577, Japan

Location

Unknown Facility

Yokohama, Kanagawa, 236-0004, Japan

Location

Unknown Facility

Sayama, Osaka, 589-8511, Japan

Location

Related Publications (2)

• 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.

  PMID: 27272279 RESULT

• 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.

  PMID: 28478485 DERIVED

MeSH Terms

Conditions

Prostatic Neoplasms

Interventions

radium Ra 223 dichloride

Condition Hierarchy (Ancestors)

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

Study Officials

• Bayer Study Director

  Bayer

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 1, 2012
• First Posted: March 29, 2012
• Study Start: March 1, 2012
• Primary Completion: October 1, 2012
• Study Completion: April 1, 2016
• Last Updated: October 17, 2016

Record last verified: 2016-10

Locations

JP (3)