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
The duration of the study for an individual subject will include:
1. Baseline assessments: within 7 days prior to the first dose of IMP.
2. Study treatment period(s):
Subjects will start 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, start with initiation period; subjects must complete all the visits
in the initiation period before moving to the extension period.
- if ≥2 cycles, start with extension period; duration of extension period is
- Subjects who will take a SAR245408 or SAR245409 daily dose higher than their
established dose of SAR245408 or SAR245409, respectively, in the parental study
will enter the study on Day 1 of the initiation period.
- Subjects who had dose interrupted in the parental study but fulfill parental
protocol criteria to restart IMP treatment will enter the treatment-extension
study on Day 1 of the initiation period.
- Subjects who fulfill the parental study criteria for IMP treatment continuation
but have ongoing Grade 2 AE(s) will enter the treatment-extension study on Day 1
of the initiation period.
Subjects may continue to receive study treatment until disease progression,
unacceptable toxicity, withdrawal of consent, or until commercial supplies of SAR245408
or SAR245409 are available to them outside of the clinical trial
3. Follow-up assessments: 23 to 37 days after the last dose of IMP.
Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Safety and tolerability as measured by the incidence and frequency of adverse events (AEs) and laboratory abnormalities
Safety will be assessed continuously. Subjects will have a visit on site every week (Cycle 1) or every 2 weeks (Cycle 2) during the initiation period (if applicable), and every 4 or 6 weeks during the extension period.
Up to 2 years
Clinical Sciences & Operations
United States: Food and Drug Administration
|Investigational Site Number 840002||Newark, New Jersey 07103|
|Investigational Site Number 840008||Los Angeles, California 90048|
|Investigational Site Number 840005||San Antonio, Texas 78229|
|Investigational Site Number 840004||Boston, Massachusetts 02115|
|Investigational Site Number 840009||Modesto, California 95355|
|Investigational Site Number 840006||Augusta, Georgia 30912|
|Investigational Site Number 840001||Detroit, Michigan 48201|
|Investigational Site Number 840003||Dallas, Texas 75230|
|Investigational Site Number 840010||Birmingham, Alabama 35205|
|Investigational Site Number 840015||Columbus, Ohio 43210|
|Investigational Site Number 840007||Nashville, Tennessee 37232|