An Open-label Study Investigating the Disposition and QT/QTc Interval Effects of 400 mg [14C]-Iniparib(3.7 MBq, 100 µCi)
NCT ID: NCT01161836
Last Updated: 2013-09-24
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
7 participants
INTERVENTIONAL
2010-07-31
2011-06-30
Brief Summary
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During Segment 1, patients are administered a single IV administration of \[14C\]-iniparib.
During Segment 2, patients are administered iniparib with or without additional chemotherapy. Acceptable chemotherapy regimens is limited to those for which previous experience with iniparib exists.
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
BASIC_SCIENCE
NONE
Study Groups
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iniparib
Segment 1: 400 mg \[14C\]-iniparib single administration
Segment 2: Iniparib, 5.6mg/kg, extension treatment with or without additional chemotherapy
Iniparib
Solution for infusion
60-minute intravenous infusion
Interventions
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Iniparib
Solution for infusion
60-minute intravenous infusion
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
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18 Years
65 Years
ALL
No
Sponsors
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Sanofi
INDUSTRY
Responsible Party
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Principal Investigators
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Clinical Sciences & Operations
Role: STUDY_DIRECTOR
Sanofi
Locations
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Northwest Medical Specialties
Tacoma, Washington, United States
Countries
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Other Identifiers
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20100109
Identifier Type: OTHER
Identifier Source: secondary_id
BEX11505
Identifier Type: -
Identifier Source: org_study_id
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