Skip to main content
OpenTrials
Completed

NCT Number: NCT01161836

An Open-label Study Investigating the Disposition and QT/QTc Interval Effects of 400 mg [14C]-Iniparib(3.7 MBq, 100 µCi)

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Advanced Solid Tumors

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Northwest Medical Specialties

Tacoma, Washington, 98405, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Iniparib

Drug

Solution for infusion

60-minute intravenous infusion

Other names: SAR240550, BSI-201

Primary outcomes

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

    Time frame: Up to 35 days

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

    Time frame: up to 35 days

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

    Time frame: 96 hours

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

    Time frame: Up to 35 days

Secondary outcomes

  1. The clinical and biological tolerability of iniparib.

    Time frame: During treatment and until 30 days post treatment

Sponsors and collaborators

Lead sponsor

Sanofi

Industry

Registry information

Official study title

An Open-label Study Investigating the Disposition and QT/QTc Interval Effects of 400 mg [14C]-Iniparib(3.7 MBq, 100 µCi) Administered at Cycle 1 as a 60-minute Intravenous Infusion to Patients With Advanced Solid Tumors Followed by Extended Treatment With BSI-201 With or Without Additional Chemotherapy

Important dates

Study start
2010
Primary completion
2011
Study completion
2011
First posted
Jul 14, 2010
Registry last updated
Sep 24, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.