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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Sanofi
ClinicalTrials.gov Identifier:
NCT01161836
First received: July 12, 2010
Last updated: September 23, 2013
Last verified: September 2013
  Purpose

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.


Condition Intervention Phase
Advanced Solid Tumors
Drug: Iniparib
Phase 1

Access to an investigational treatment associated with this study is no longer available outside the clinical trial.   More info ...

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

Resource links provided by NLM:


Further study details as provided by Sanofi:

Primary Outcome Measures:
  • The excretion balance and systemic exposure of radioactivity after intravenous (IV) administration of [14C]-iniparib [ Time Frame: Up to 35 days ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • The effects of iniparib on changes in the ECG with special focus on the QTcF interval duration [ Time Frame: 96 hours ] [ Designated as safety issue: Yes ]
  • The metabolic pathways of iniparib and identify the chemical structures of the main metabolites. [ Time Frame: Up to 35 days ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • The clinical and biological tolerability of iniparib. [ Time Frame: During treatment and until 30 days post treatment ] [ Designated as safety issue: Yes ]

Enrollment: 7
Study Start Date: July 2010
Study Completion Date: June 2011
Primary Completion Date: February 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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:
  • SAR240550
  • BSI-201

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01161836

Locations
United States, Washington
Northwest Medical Specialties
Tacoma, Washington, United States, 98405
Sponsors and Collaborators
Sanofi
Investigators
Study Director: Clinical Sciences & Operations Sanofi
  More Information

No publications provided

Responsible Party: Sanofi
ClinicalTrials.gov Identifier: NCT01161836     History of Changes
Other Study ID Numbers: BEX11505, 20100109
Study First Received: July 12, 2010
Last Updated: September 23, 2013
Health Authority: United States: Food and Drug Administration

ClinicalTrials.gov processed this record on April 22, 2014