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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


Phase 1
18 Years
65 Years
Not Enrolling
Both
Advanced Solid Tumors

Thank you

Trial Information

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

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.

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

The excretion balance and systemic exposure of radioactivity after intravenous (IV) administration of [14C]-iniparib

Outcome Time Frame:

Up to 35 days

Safety Issue:

No

Principal Investigator

Clinical Sciences & Operations

Investigator Role:

Study Director

Investigator Affiliation:

Sanofi

Authority:

United States: Food and Drug Administration

Study ID:

BEX11505

NCT ID:

NCT01161836

Start Date:

July 2010

Completion Date:

June 2011

Related Keywords:

  • Advanced Solid Tumors

Name

Location

Northwest Medical SpecialtiesTacoma, Washington  98405