check_circleStudy Completed

Prostate Cancer, Metastases, Pharmacokinetics

Alpharadin™ (Radium-223 chloride) Safety and Dosimetry With HRPC That Has Metastasized to the Skeleton

Trial purpose

The purpose of the study is to investigate the safety, biodistribution, radiation dosimetry and pharmacokinetics of three intravenous escalating dose levels of Xofigo (Alpharadin).

Key Participants Requirements

Sex

Male

Age

18 - N/A

Trial summary

Enrollment Goal
10
Trial Dates
August 2008 - October 2009
Phase
Phase 1
Could I Receive a placebo
No
Products
Xofigo (Radium-223 dichloride, BAY88-8223)
Accepts Healthy Volunteer
No

Where to participate

StatusInstitutionLocation
Completed
Memorial Sloan-Kettering Cancer CenterNew York, 10065, United States

Primary Outcome

  • All safety data, including adverse events, occurrence of treatment-emergent adverse events, changes in laboratory variables, vital signs, ECG, physical examination, long term radiation toxicity, including results of bone marrow biopsy
    date_rangeTime Frame:
    1 year
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    Safety Issue:
    Yes
  • Biodistribution, dosimetry and pharmacokinetics (whole body activity assessment, the counts in region-of-interest (ROIs) from anterior and posterior whole-body images, and the assay of activity in blood
    date_rangeTime Frame:
    6 days after injection
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    Safety Issue:
    No

Secondary Outcome

  • Post-treatment PSA effect: PSA decline, time to PSA progression after PSA response
    date_rangeTime Frame:
    1 year
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    Safety Issue:
    No
  • Post-treatment bone markers effect: Changes in bone marker values from pre- to post administration
    date_rangeTime Frame:
    1 year
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    Safety Issue:
    No
  • Circulating tumor cells (CTCs) enumeration and role of molecular profiling of CTC in predicting sensitivity to treatment and treatment response
    date_rangeTime Frame:
    1 year
    enhanced_encryption
    Safety Issue:
    No

Trial design

Phase 1, Open-label, Single Ascending-dose Study to Assess Safety, Pharmacokinetics, Biodistribution and Radiation Dosimetry of Intravenous Doses of Alpharadin™ Injection (Radium-223 Chloride) in Patients With HRPC and Skeletal Metastases
Trial Type
Interventional
Intervention Type
Drug
Trial Purpose
Basic Science
Allocation
N/A
Blinding
Open Label
Assignment
Single Group Assignment
Trial Arms
1