International, Multi-Center, Open-label, Treatment Extension Study of Iniparib as Monotherapy or in Combination Chemotherapeutic Regimens in Cancer Patients Who Have Derived Clinical Benefit From Iniparib Following Completion of a Phase 1, 2 or 3 Parental Study
The Treatment Extension protocol consists of three time points/periods: the Screening Period
(during which assessments are performed to determine whether the patient meets the criteria
to participate in the study), the Treatment Period (during which the patient receives
treatment with the study drug(s)), and the Post-Treatment Period (during which patients
complete an evaluation approximately 30 days after the last dose of study drug). Patients
may continue to participate on the Treatment Extension study as long as they meet criteria
to continue to receive therapy, tolerate the treatment regimen, do not develop progressive
disease (PD), do not discontinue from iniparib, do not withdraw consent, or until iniparib
becomes commercially available.
Interventional
Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Number of participants with incidence of adverse events by NCI-CTCAE version 4.03
Up to 30 days after last treatment dose
Yes
Clinical Sciences & Operations
Study Director
Sanofi
United States: Food and Drug Administration
LTS12674
NCT01593228
May 2012
March 2014
Name | Location |
---|---|
Investigational Site Number 840046 | La Jolla, California 92037 |
Investigational Site Number 840027 | Jacksonville, Florida 32256 |
Investigational Site Number 840017 | East Orange, New Jersey 07018 |
Investigational Site Number 840028 | Chattanooga, Tennessee 37404 |
Investigational Site Number 840006 | Rochester, Minnesota 55905 |
Investigational Site Number 840001 | Detroit, Michigan 48201 |
Investigational Site Number 840003 | Dallas, Texas 75230 |
Investigational Site Number 840013 | Birmingham, Alabama 35205 |
Investigational Site Number 840025 | Sioux City, Iowa 51105 |
Investigational Site Number 840002 | Jackson, Mississippi 39202 |
Investigational Site Number 840010 | Albany, New York 12206 |
Investigational Site Number 840007 | Austin, Texas 78731 |
Investigational Site Number 840019 | Plano, Texas 75075 |
Investigational Site Number 840033 | Santa Maria, California 93454-8903 |
Investigational Site Number 840008 | Denver, Colorado 80218 |
Investigational Site Number 840055 | Tucker, Georgia 30084 |
Investigational Site Number 840039 | Maywood, Illinois 60153 |
Investigational Site Number 840012 | Indianapolis, Indiana 46227 |
Investigational Site Number 840030 | Boston, Massachusetts 02115 |
Investigational Site Number 840004 | St. Louis, Missouri 63141 |
Investigational Site Number 840022 | Las Vegas, Nevada 89169 |
Investigational Site Number 840015 | Charlotte, North Carolina 28204 |
Investigational Site Number 840043 | Cleveland, Ohio 44106 |
Investigational Site Number 840021 | Pittsburgh, Pennsylvania 15213 |
Investigational Site Number 840005 | Norfolk, Virginia 23502 |
Investigational Site Number 840009 | Vancouver, Washington 98684 |