Primary Objective: Participants achieving an Objective Response Rate Secondary Objective: * Progression Free Survival * Overall Survival * Response Duration * Safety
The screening period = up to 4 weeks prior to SAR3419 administration The treatment period = from the day of first administration of SAR3419 until the End-Of-Treatment visit. All patients will receive SAR3419 until evidence of disease progression, unacceptable toxicity or other reasons for therapy discontinuation - After therapy discontinuation all patients will enter a safety follow-up period of 42 days starting from the day of administration of the last dose of SAR3419 and ending with the End Of Treatment visit. All patients, regardless whether they have progressed or not, will be followed until death or end of study to evaluate survival for at least 18 months.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
61
Pharmaceutical form:concentrate for solution for infusion Route of administration: intravenous
Number of participants achieving an Objective Response Rate
Time frame: 18 months
Number of participants with Adverse Events
Time frame: Up to 1 year
Response duration - Time
Time frame: Up to 18 months after the first infusion of the last patient
Progression Free Survival - Time
Time frame: Up to 18 months after the first infusion of the last patient
Overall Survival - Time
Time frame: Up to 18 months after the first infusion of the last patient
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Investigational Site Number 840001
Denver, Colorado, United States
Investigational Site Number 840003
Augusta, Georgia, United States
Investigational Site Number 840005
Boise, Idaho, United States
Investigational Site Number 056002
Ghent, Belgium
Investigational Site Number 056001
Leuven, Belgium
Investigational Site Number 203002
Brno, Czechia
Investigational Site Number 203003
Prague, Czechia
Investigational Site Number 203001
Prague, Czechia
Investigational Site Number 376003
Jerusalem, Israel
Investigational Site Number 376002
Tel Litwinsky, Israel
...and 18 more locations