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

October 14, 2016 updated by: Bayer

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

19

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Japan
    • Chiba
      • Kashiwa, Chiba, Japan, 277-8577
    • Kanagawa
      • Yokohama, Kanagawa, Japan, 236-0004
    • Osaka
      • Osakasayama, Osaka, Japan, 589-8511

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Radium-223 dichloride [50 kBq/kg]
Drug: Radium-223 dichloride (Xofigo, BAY88-8223)
Radium-223 dichloride (Xofigo, BAY88-8223) 50 kBq/kg
Drug: Radium-223 dichloride (Xofigo, BAY88-8223)
Radium-223 dichloride (Xofigo, BAY88-8223) 100 kBq/kg
Drug: Radium-223 dichloride (Xofigo, BAY88-8223)
Expansion arm: Radium-223 dichloride (Xofigo, BAY88-8223) 50 kBq/kg
Experimental: Radium-223 dichloride [100 kBq/kg]
Drug: Radium-223 dichloride (Xofigo, BAY88-8223)
Radium-223 dichloride (Xofigo, BAY88-8223) 50 kBq/kg
Drug: Radium-223 dichloride (Xofigo, BAY88-8223)
Radium-223 dichloride (Xofigo, BAY88-8223) 100 kBq/kg
Drug: Radium-223 dichloride (Xofigo, BAY88-8223)
Expansion arm: Radium-223 dichloride (Xofigo, BAY88-8223) 50 kBq/kg
Experimental: Radium-223 dichloride [expansion]
Drug: Radium-223 dichloride (Xofigo, BAY88-8223)
Radium-223 dichloride (Xofigo, BAY88-8223) 50 kBq/kg
Drug: Radium-223 dichloride (Xofigo, BAY88-8223)
Radium-223 dichloride (Xofigo, BAY88-8223) 100 kBq/kg
Drug: Radium-223 dichloride (Xofigo, BAY88-8223)
Expansion arm: Radium-223 dichloride (Xofigo, BAY88-8223) 50 kBq/kg

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of participants with Critical toxicities
Time Frame: Up to day 28
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
Time Frame: up to 72 hours
up to 72 hours
Area under the concentration - time curve (AUC) of BAY88-8223 for blood samples
Time Frame: up to 72 hours
up to 72 hours

Secondary Outcome Measures

Outcome Measure
Time Frame
Changes in prostate specific antigen (PSA)
Time Frame: baseline, up to 12 weeks
baseline, up to 12 weeks
Overall Survival
Time Frame: Up to 36 months
Up to 36 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Bayer

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2012

Primary Completion (Actual)

October 1, 2012

Study Completion (Actual)

April 1, 2016

Study Registration Dates

First Submitted

March 1, 2012

First Submitted That Met QC Criteria

March 27, 2012

First Posted (Estimate)

March 29, 2012

Study Record Updates

Last Update Posted (Estimate)

October 17, 2016

Last Update Submitted That Met QC Criteria

October 14, 2016

Last Verified

October 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 15354

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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