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| Sponsor: | Algeta ASA |
|---|---|
| Information provided by: | Algeta ASA |
| ClinicalTrials.gov Identifier: | NCT00667537 |
Purpose
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 |
|---|---|---|
|
Hormone Refractory Prostate Cancer Bone Metastases |
Drug: Alpharadin TM (Radium-223) |
Phase I |
| Study Type: | Interventional |
| Study Design: | Endpoint Classification: Pharmacokinetics/Dynamics Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Basic Science |
| 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 |
| Study Completion Date: | December 2009 |
| Primary Completion Date: | February 2008 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| 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.
|
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:
Eligibility| 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:
Contacts and Locations| 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 |
More Information
| Responsible Party: | Gillies O'Bryan-Tear, CMO, Algeta ASA |
| ClinicalTrials.gov Identifier: | NCT00667537 History of Changes |
| Other Study ID Numbers: | BC1-05 |
| Study First Received: | April 24, 2008 |
| Last Updated: | June 8, 2011 |
| Health Authority: | United Kingdom: Medicines and Healthcare Products Regulatory Agency |
|
Hormone Refractory Prostate Cancer Bone Metastases Radium-223 |
Biodistribution Dosimetry Pharmacokinetics |
|
Neoplasm Metastasis Neoplasms, Second Primary Prostatic Neoplasms Bone Neoplasms Bone Marrow Diseases Neoplastic Processes Neoplasms Pathologic Processes Genital Neoplasms, Male Urogenital Neoplasms |
Neoplasms by Site Genital Diseases, Male Prostatic Diseases Bone Diseases Musculoskeletal Diseases Hematologic Diseases Hormones Hormones, Hormone Substitutes, and Hormone Antagonists Physiological Effects of Drugs Pharmacologic Actions |