COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC:

Get the latest research information from NIH: Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01161836
Recruitment Status : Completed
First Posted : July 14, 2010
Last Update Posted : September 24, 2013
Information provided by (Responsible Party):

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.

Condition or disease Intervention/treatment Phase
Advanced Solid Tumors Drug: Iniparib Phase 1

Expanded Access : An investigational treatment associated with this study is no longer available outside the clinical trial.   More info ...

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 7 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (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
Study Start Date : July 2010
Actual Primary Completion Date : February 2011
Actual Study Completion Date : June 2011

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:
  • SAR240550
  • BSI-201

Primary Outcome Measures :
  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 Outcome Measures :
  1. The clinical and biological tolerability of iniparib. [ Time Frame: During treatment and until 30 days post treatment ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Layout table for eligibility information
Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01161836

Layout table for location information
United States, Washington
Northwest Medical Specialties
Tacoma, Washington, United States, 98405
Sponsors and Collaborators
Layout table for investigator information
Study Director: Clinical Sciences & Operations Sanofi
Layout table for additonal information
Responsible Party: Sanofi Identifier: NCT01161836    
Other Study ID Numbers: BEX11505
20100109 ( Other Identifier: BiPar )
First Posted: July 14, 2010    Key Record Dates
Last Update Posted: September 24, 2013
Last Verified: September 2013
Additional relevant MeSH terms:
Layout table for MeSH terms
Poly(ADP-ribose) Polymerase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents