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

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

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01161836

Enrollment

Registered

2010-07-14

Start date

2010-07-31

Completion date

2011-06-30

Last updated

2013-09-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Advanced Solid Tumors

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.

Interventions

DRUGIniparib

Solution for infusion 60-minute intravenous infusion

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

BASIC_SCIENCE

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 65 Years

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame
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

Measure	Time frame
The clinical and biological tolerability of iniparib.	During treatment and until 30 days post treatment

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026