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

Prostatic Neoplasms Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01565746
• Other study ID #: 15354
• Status: Completed
• Phase: Phase 1
• First received: March 1, 2012
• Last updated: October 14, 2016
• Start date: March 2012
• Est. completion date: April 2016

Study information

• Verified date: October 2016
• Source: Bayer
• Contact: n/a
• Is FDA regulated: No
• Health authority: Japan: Pharmaceuticals and Medical Devices Agency
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 19
• Est. completion date: April 2016
• Est. primary completion date: October 2012
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 20 Years and older

Eligibility

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

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Prostatic Neoplasms

Intervention

Drug:
• Radium-223 dichloride (Xofigo, BAY88-8223)
Radium-223 dichloride (Xofigo, BAY88-8223) 50 kBq/kg
• Radium-223 dichloride (Xofigo, BAY88-8223)
Radium-223 dichloride (Xofigo, BAY88-8223) 100 kBq/kg
• Radium-223 dichloride (Xofigo, BAY88-8223)
Expansion arm: Radium-223 dichloride (Xofigo, BAY88-8223) 50 kBq/kg

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Bayer

Country where clinical trial is conducted

Japan, 

References & Publications (1)

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 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Yes
Primary	Maximum drug concentration in blood after single dose administration (Cmax) of BAY88-8223 for blood samples		up to 72 hours	No
Primary	Area under the concentration - time curve (AUC) of BAY88-8223 for blood samples		up to 72 hours	No
Secondary	Changes in prostate specific antigen (PSA)		baseline, up to 12 weeks	No
Secondary	Overall Survival		Up to 36 months	No

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