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

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.

Study Overview

• Status: Completed
• Conditions: Advanced Solid Tumors
• Intervention / Treatment: Drug: Iniparib

• Study Type: Interventional
• Enrollment (Actual): 7
• Phase: Phase 1

Expanded Access

No longer available outside the clinical trial. See expanded access record.

Contacts and Locations

Study Locations

• United States
  • Washington
    • Tacoma, Washington, United States, 98405
      • Northwest Medical Specialties

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: BASIC_SCIENCE
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: iniparib; Segment 1: 400 mg [14C]-iniparib single administration Segment 2: Iniparib, 5.6mg/kg, extension treatment with or without additional chemotherapy	Drug: Iniparib; Solution for infusion 60-minute intravenous infusion; Other Names: BSI-201; SAR240550

What is the study measuring?

Primary Outcome Measures

Outcome 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 Outcome Measures

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

Collaborators and Investigators

• Sponsor: Sanofi

Study record dates

Study Major Dates

• Study Start: July 1, 2010
• Primary Completion (ACTUAL): February 1, 2011
• Study Completion (ACTUAL): June 1, 2011

Study Registration Dates

• First Submitted: July 12, 2010
• First Submitted That Met QC Criteria: July 12, 2010
• First Posted (ESTIMATE): July 14, 2010

Study Record Updates

• Last Update Posted (ESTIMATE): September 24, 2013
• Last Update Submitted That Met QC Criteria: September 23, 2013
• Last Verified: September 1, 2013

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Antineoplastic Agents; Poly(ADP-ribose) Polymerase Inhibitors; Iniparib
• Other Study ID Numbers: BEX11505; 20100109 (OTHER: BiPar)