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

Primary Purpose

Prostatic Neoplasms

Status

Completed

Phase

Phase 1

Locations

Japan

Study Type

Interventional

Intervention

Radium-223 dichloride (Xofigo, BAY88-8223)

About this trial

This is an interventional treatment trial for Prostatic Neoplasms focused on measuring BAY88-8223, radium-223 dichloride, prostate cancer

Eligibility Criteria

20 Years - undefined (Adult, Older Adult)MaleDoes not accept healthy volunteers

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

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Arm Label

Radium-223 dichloride [50 kBq/kg]

Radium-223 dichloride [100 kBq/kg]

Radium-223 dichloride [expansion]

Arm Description

Outcomes

Primary Outcome Measures

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

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

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

Secondary Outcome Measures

Changes in prostate specific antigen (PSA)

Overall Survival

Full Information

NCT ID

NCT01565746

First Posted

March 1, 2012

Last Updated

October 14, 2016

Sponsor

Bayer

1. Study Identification

Unique Protocol Identification Number

NCT01565746

Brief Title

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

2. Study Status

Record Verification Date

October 2016

Overall Recruitment Status

Completed

Study Start Date

March 2012 (undefined)

Primary Completion Date

October 2012 (Actual)

Study Completion Date

April 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Bayer

4. Oversight

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Prostatic Neoplasms

Keywords

BAY88-8223, radium-223 dichloride, prostate cancer

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

19 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Radium-223 dichloride [50 kBq/kg]

Arm Type

Experimental

Arm Title

Radium-223 dichloride [100 kBq/kg]

Arm Type

Experimental

Arm Title

Radium-223 dichloride [expansion]

Arm Type

Experimental

Intervention Type

Drug

Intervention Name(s)

Radium-223 dichloride (Xofigo, BAY88-8223)

Intervention Description

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

Intervention Type

Drug

Intervention Name(s)

Radium-223 dichloride (Xofigo, BAY88-8223)

Intervention Description

Radium-223 dichloride (Xofigo, BAY88-8223) 100 kBq/kg

Intervention Type

Drug

Intervention Name(s)

Radium-223 dichloride (Xofigo, BAY88-8223)

Intervention Description

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

Primary Outcome Measure Information:

Title

Number of participants with Critical toxicities

Description

Time Frame

Up to day 28

Title

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

Time Frame

up to 72 hours

Title

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

Time Frame

up to 72 hours

Secondary Outcome Measure Information:

Title

Changes in prostate specific antigen (PSA)

Time Frame

baseline, up to 12 weeks

Title

Overall Survival

Time Frame

Up to 36 months

10. Eligibility

Sex

Male

Minimum Age & Unit of Time

20 Years

Accepts Healthy Volunteers

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Bayer Study Director

Organizational Affiliation

Bayer

Official's Role

Study Director

Facility Information:

City

Kashiwa

State/Province

Chiba

ZIP/Postal Code

277-8577

Country

Japan

City

Yokohama

State/Province

Kanagawa

ZIP/Postal Code

236-0004

Country

Japan

City

Osakasayama

State/Province

Osaka

ZIP/Postal Code

589-8511

Country

Japan

12. IPD Sharing Statement

Citations:

PubMed Identifier

27272279

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.

Results Reference

result

PubMed Identifier

28478485

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.

Results Reference

derived

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

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