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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

Results pending

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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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

7 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-07-31

Study Completion Date

2011-06-30

Brief Summary

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This is a Phase 1, multi-center, open-label study.

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.

Detailed Description

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Conditions

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Advanced Solid Tumors

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

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

Group Type EXPERIMENTAL

Iniparib

Intervention Type DRUG

Solution for infusion

60-minute intravenous infusion

Interventions

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Iniparib

Solution for infusion

60-minute intravenous infusion

Intervention Type DRUG

Other Intervention Names

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SAR240550 BSI-201

Eligibility Criteria

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Inclusion Criteria

Male or female patients with advanced solid tumors that are refractory to standard treatment or for which no standard treatment exists; patients must be at least 18 years old.

Additional criteria are also required and should be evaluated by the research staff.
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Sanofi

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

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

Site Status

Countries

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United States

Other Identifiers

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20100109

Identifier Type: OTHER

Identifier Source: secondary_id

BEX11505

Identifier Type: -

Identifier Source: org_study_id