An Open-Label Study of YM155 + Docetaxel in Subjects With Advanced Hormone Refractory Prostate Cancer and Other Solid Tumors
NCT ID: NCT00514267
Last Updated: 2015-08-13
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
PHASE1/PHASE2
32 participants
INTERVENTIONAL
2007-05-31
2010-03-31
Brief Summary
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Detailed Description
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Part 1: Assessment of feasibility and safety of administering YM155 in combination with docetaxel and prednisone in subjects with hormone refractory prostate cancer (HRPC) \[ ENROLLMENT COMPLETED \]
Part 2: Assessment of feasibility and safety of administering YM155 in combination with docetaxel in subjects with solid tumors (except HRPC).
This registration has been updated to reflect the design requirements of PART 2.
Conditions
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Study Design
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NON_RANDOMIZED
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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1. HRPC
YM 155
IV
Docetaxel
IV
Prednisone
Oral
2. Solid Tumors
YM 155
IV
Docetaxel
IV
Interventions
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YM 155
IV
Docetaxel
IV
Prednisone
Oral
Eligibility Criteria
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Inclusion Criteria
* Male subjects with histologically or cytologically confirmed adenocarcinoma of the prostate with clinical or radiological evidence of metastatic disease.
Part 2:
* Subjects with histologically and cytologically confirmed solid tumors with measurable disease (except HRPC).
Exclusion Criteria
18 Years
ALL
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_DIRECTOR
Astellas Pharma Global Development
Locations
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San Antonio, Texas, United States
Countries
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Other Identifiers
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155-CL-025
Identifier Type: -
Identifier Source: org_study_id
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