An Open-label, Non-randomized, Dose Escalation, Safety and Pharmacokinetic Phase I Study of Ombrabulin (AVE8062) in Combination With Bevacizumab Administered by Intravenous Infusion Every 3 Weeks in Patients With Advanced Solid Tumors.
The duration of the study for each patient will include an up to 28-day screening phase,
21-day study treatment cycles, an end of treatment visit with a follow-up period. Each
patient will participate in only one dose group and will receive AVE8062 with bevacizumab
every 3 weeks until disease progression or unacceptable toxicities, withdrawal of consent
or Investigator's decision.
Interventional
Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Incidence of Dose Limiting Toxicities (DLTs) that will define the MTD
3 weeks
Yes
Clinical Sciences & Operations
Study Director
Sanofi
France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
TCD11379
NCT01193595
September 2010
October 2013
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