Phase II Study of ASP3550 in Patients With Prostate Cancer
NCT ID: NCT00568516
Last Updated: 2014-10-29
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
273 participants
INTERVENTIONAL
2007-10-31
2009-10-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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1.Low dose group
ASP3550
subcutaneous administration
2.High dose group
ASP3550
subcutaneous administration
Interventions
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ASP3550
subcutaneous administration
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Is a patient in whom endocrine treatment is indicated. Patients with rising serum PSA after having prostatectomy or radiotherapy performed with curative intention may be included
* Has a serum testosterone level above 1.5 ng/mL at screening
* Has an ECOG (Eastern Co-operative Oncology Group) P.S. (Performance Status) score of 0 to 2
Exclusion Criteria
* Is being treated with a 5α-reductase inhibitor
* Is a candidate for curative therapy, i.e., radical prostatectomy or radiotherapy within 12 months
* Has concurrent or a history of severe asthma (defined as a need for daily treatment with inhalation steroids), anaphylactic reactions, severe urticaria and angioedema
20 Years
MALE
No
Sponsors
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Astellas Pharma Inc
INDUSTRY
Responsible Party
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Principal Investigators
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Central Contact
Role: STUDY_CHAIR
Astellas Pharma Inc
Locations
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Chugoku, , Japan
Chūbu, , Japan
Hokkaido, , Japan
Kansai, , Japan
Kanto, , Japan
Kyusyu, , Japan
Shikoku, , Japan
Tōhoku, , Japan
Countries
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Other Identifiers
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3550-CL-0003
Identifier Type: -
Identifier Source: org_study_id
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