Dose Escalation, Safety, Pharmacokinetic and Pharmacodynamic, First in Man Study, of SAR125844 Single Agent Administered as Slow Intravenous Infusion in Adult Patients With Advanced Malignant Solid Tumors
The duration of the study for one patient in the dose escalation phase of the study will
include a screening period of up to 3 weeks and a 4-week treatment cycle(s). The patients
may continue treatment until disease progression, unacceptable toxicity, or willingness to
stop, followed by a minimum of 30-day follow-up. The study will also include 2 expansion
cohorts. If a patient treated in dose escalation part or in an expansion cohorts, continues
to benefit from the treatment at the time of Clinical Study Report, the patient can continue
study treatment for a maximum of 1 year and will continue to undergo all assessments as per
the study flowchart. Such patients will be followed at least until 30 days after the last
IMP administration.
Interventional
Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label
Dose Escalation To determine the maximum tolerated dose (MTD) of SAR125844
At day 28 of Cycle 1 of each treated patient, DLT is assessed
Yes
Clinical Sciences & Operations
Study Director
Sanofi
France: Committee for the Protection of Personnes
TED11449
NCT01391533
July 2011
January 2016
Name | Location |
---|