Spots Global Cancer Trial Database for Open Label Treatment Extension Study With SAR245408 or SAR245409 as a Monotherapy or as a Combination Regimen
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Trial Identification
Brief Title: Open Label Treatment Extension Study With SAR245408 or SAR245409 as a Monotherapy or as a Combination Regimen
Official Title: International, Multicenter, Open-label, Treatment-extension Study for Subjects Who Completed a Phase 1 or Phase 2 Parental Study to Continue Receiving Treatment With SAR245408 or SAR245409 as a Monotherapy or as a Combination Regimen
Study ID: NCT01587040
Conditions
Study Description
Brief Summary: Primary Objective: The purpose of this study was to determine the long term safety and tolerability of SAR245408 and SAR245409 as a monotherapy or as part of a combination regimen in participants who were benefiting from treatment.
Detailed Description: The duration of the study for an individual participant included: 1. Baseline assessments: within 7 days prior to the first dose of investigational medicinal product (IMP). 2. Study treatment period(s): Participants started study treatment at the beginning of the initiation or extension periods based on the length of prior therapy with SAR245408 or SAR245409 * if \<2 cycles, started with initiation period; Participant must have had completed all the visits in the initiation period before moving to the extension period. * if \>=2 cycles, started with extension period; duration of extension period was unlimited. * Participants who took a SAR245408 or SAR245409 daily dose higher than their established dose of SAR245408 or SAR245409, respectively, in the parental study entered the study on Day 1 of the initiation period. * Participants who had dose interrupted in the parental study but fulfilled parental protocol criteria to restart IMP treatment entered the treatment-extension study on Day 1 of the initiation period. * Participants who fulfilled the parental study criteria for IMP treatment continuation but had ongoing Grade 2 adverse events (AEs) entered the treatment-extension study on Day 1 of the initiation period. Participants continued to receive study treatment until disease progression, unacceptable toxicity, withdrawal of consent, or until commercial supplies of SAR245408 or SAR245409 were available to them outside of the clinical trial. 3. Follow-up assessments: 23 to 37 days after the last dose of IMP.
Keywords
Eligibility
Minimum Age:
Eligible Ages: CHILD, ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
Investigational Site Number 840010, Birmingham, Alabama, United States
Investigational Site Number 840009, Los Angeles, California, United States
Investigational Site Number 840008, Los Angeles, California, United States
Investigational Site Number 840022, Denver, Colorado, United States
Investigational Site Number 840104, Fort Myers, Florida, United States
Investigational Site Number 840006, Augusta, Georgia, United States
Investigational Site Number 840004, Boston, Massachusetts, United States
Investigational Site Number 840021, Saint Louis, Missouri, United States
Investigational Site Number 840002, New Brunswick, New Jersey, United States
Investigational Site Number 840020, Canton, Ohio, United States
Investigational Site Number 840015, Columbus, Ohio, United States
Investigational Site Number 840017, Philadelphia, Pennsylvania, United States
Investigational Site Number 840007, Nashville, Tennessee, United States
Investigational Site Number 840003, Dallas, Texas, United States
Investigational Site Number 840005, San Antonio, Texas, United States
Investigational Site Number 840018, Morgantown, West Virginia, United States
Investigational Site Number 056001, Leuven, , Belgium
Investigational Site Number 250004, Montpellier, , France
Investigational Site Number 250003, Pierre Benite Cedex, , France
Investigational Site Number 250005, Rouen Cedex, , France
Investigational Site Number 724001, Barcelona, , Spain
Contact Details
Name: Clinical Sciences & Operations
Affiliation: Sanofi
Role: STUDY_DIRECTOR
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