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

Advanced Solid Tumors Clinical Trial

Official 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01161836
• Other study ID #: BEX11505
• Secondary ID: 20100109
• Status: Completed
• Phase: Phase 1
• First received: July 12, 2010
• Last updated: September 23, 2013
• Start date: July 2010
• Est. completion date: June 2011

Study information

• Verified date: September 2013
• Source: Sanofi
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 7
• Est. completion date: June 2011
• Est. primary completion date: February 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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 Design

Endpoint Classification: Pharmacokinetics Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Advanced Solid Tumors

Intervention

Drug:
• Iniparib
Solution for infusion 60-minute intravenous infusion

Locations

Country	Name	City	State
United States	Northwest Medical Specialties	Tacoma	Washington

Sponsors (1)

Lead Sponsor	Collaborator
Sanofi

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The excretion balance and systemic exposure of radioactivity after intravenous (IV) administration of [14C]-iniparib		Up to 35 days	No
Primary	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	No
Primary	The effects of iniparib on changes in the ECG with special focus on the QTcF interval duration		96 hours	Yes
Primary	The metabolic pathways of iniparib and identify the chemical structures of the main metabolites.		Up to 35 days	No
Secondary	The clinical and biological tolerability of iniparib.		During treatment and until 30 days post treatment	Yes