NCT01161836

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
7

participants targeted

Target at below P25 for phase_1

Timeline
Completed

Started Jul 2010

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2010

Completed
11 days until next milestone

First Submitted

Initial submission to the registry

July 12, 2010

Completed
2 days until next milestone

First Posted

Study publicly available on registry

July 14, 2010

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2011

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2011

Completed
Last Updated

September 24, 2013

Status Verified

September 1, 2013

Enrollment Period

7 months

First QC Date

July 12, 2010

Last Update Submit

September 23, 2013

Conditions

Advanced Solid Tumors

Outcome Measures

Primary Outcomes (4)

  • The excretion balance and systemic exposure of radioactivity after intravenous (IV) administration of [14C]-iniparib

    Up to 35 days

  • The pharmacokinetics of iniparib, iodo-amino-benzamide (IABM) and iodo-amino-benzoic acid (IABA) and their contribution to overall exposure of radioactivity

    up to 35 days

  • The effects of iniparib on changes in the ECG with special focus on the QTcF interval duration

    96 hours

  • The metabolic pathways of iniparib and identify the chemical structures of the main metabolites.

    Up to 35 days

Secondary Outcomes (1)

  • The clinical and biological tolerability of iniparib.

    During treatment and until 30 days post treatment

Study Arms (1)

iniparib

EXPERIMENTAL

Segment 1: 400 mg \[14C\]-iniparib single administration Segment 2: Iniparib, 5.6mg/kg, extension treatment with or without additional chemotherapy

Drug: Iniparib

Interventions

IniparibDRUG

Solution for infusion 60-minute intravenous infusion

Also known as: SAR240550, BSI-201
iniparib

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
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.

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Study Sites (1)

Northwest Medical Specialties

Tacoma, Washington, 98405, United States

Location

MeSH Terms

Interventions

iniparib

Study Officials

  • Clinical Sciences & Operations

    Sanofi

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR
Expanded Access
Yes

Study Record Dates

First Submitted

July 12, 2010

First Posted

July 14, 2010

Study Start

July 1, 2010

Primary Completion

February 1, 2011

Study Completion

June 1, 2011

Last Updated

September 24, 2013

Record last verified: 2013-09

Locations

US(1)