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Sponsored by: |
Algeta ASA |
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Information provided by: | Algeta ASA |
ClinicalTrials.gov Identifier: | NCT00667537 |
The purpose of this study is to evaluate the biodistribution, radiation dosimetry, pharmacokinetics and safety of the investigational radioisotope Radium-223, Alpharadin, in men with prostate cancer and bone metastases that no longer respond to hormonal treatment
Condition | Intervention | Phase |
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Hormone Refractory Prostate Cancer Bone Metastases |
Drug: Alpharadin TM (Radium-223) |
Phase I |
Study Type: | Interventional |
Study Design: | Basic Science, Open Label, Active Control, Single Group Assignment, Pharmacokinetics/Dynamics Study |
Official Title: | A Phase I Open-Label, Dosimetry, Biodistribution and Pharmacokinetic Study of Alpharadin™ in Patients With Hormone Refractory Prostate Cancer and Skeletal Metastases |
Enrollment: | 6 |
Study Start Date: | July 2007 |
Estimated Study Completion Date: | February 2009 |
Primary Completion Date: | February 2008 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1 |
Drug: Alpharadin TM (Radium-223)
IV administrations of 100 kBq/kg b.w. Two administrations will take place with an interval of 6 weeks.
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This is an open-label, biodistribution, radiation dosimetry, pharmacokinetic, safety and efficacy study of Alpharadin treatment. The treatment consists of at least two intravenous administrations of Alpharadin.
The target population is patients with asymptomatic or symptomatic (e.g. bone pain) hormone refractory prostate cancer, with documented skeletal metastases.
The study is designed to investigate safety, biodistribution, radiation dosimetry and pharmacokinetics of two separate IV administrations of Alpharadin (100 kBq/kg b.w.) separated by six weeks.
Furthermore, the secondary objectives of the study are:
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Male |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Hormone refractory with evidence of rising PSA:
Patients who have received prior antiandrogen drug therapy:
PSA progression
Laboratory requirements:
Exclusion Criteria:
Any other serious illness or medical condition, for example:
United Kingdom | |
Institute of Cancer Research and Royal Marsden Hospital | |
Sutton, United Kingdom, SM2 5PT |
Principal Investigator: | Christopher Parker, MD | Institute of Cancer Research and Royal Marsden Hospital |
Responsible Party: | Algeta ASA ( Thomas Ramdahl, President and CEO ) |
Study ID Numbers: | BC1-05 |
Study First Received: | April 24, 2008 |
Last Updated: | August 27, 2008 |
ClinicalTrials.gov Identifier: | NCT00667537 |
Health Authority: | United Kingdom: Medicines and Healthcare Products Regulatory Agency |
Hormone Refractory Prostate Cancer Bone Metastases Radium-223 |
Biodistribution Dosimetry Pharmacokinetics |
Prostatic Diseases Genital Neoplasms, Male Neoplasm Metastasis |
Urogenital Neoplasms Genital Diseases, Male Prostatic Neoplasms |
Neoplasms Neoplastic Processes Neoplasms by Site Pathologic Processes |