Primary Objective: * To determine the maximum tolerated dose based on the incidence of dose limiting toxicity and the maximum administered dose of ombrabulin in combination with cisplatin administered every 3 weeks in patients with advanced solid tumors. Secondary Objectives: * To assess the overall safety profile of the combination therapy. * To characterize the pharmacokinetic profile of ombrabulin, its active metabolite RPR 258063, and cisplatin in combination. * To evaluate anti-tumor activity of the combination therapy.
The duration of the study for each patient will include an up to 4-week screening phase, 21-day study treatment cycles, an end of treatment visit and a follow-up period 30 days after the last infusion of ombrabulin. The patient will continue treatment until disease progression, unacceptable toxicity, patient's refusal of further treatment.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
12
Pharmaceutical form:injection solution Route of administration: intravenous infusion
Pharmaceutical form: injection solution Route of administration: intravenous infusion
Sanofi-Aventis Administrative Office
Tokyo, Japan
Dose limiting toxicity
Time frame: 3 weeks (cycle 1)
Global safety profile based on treatment emergent adverse events, serious adverse events, and laboratory abnormalities
Time frame: on-treatment period + 30 days
Pharmacokinetic parameters of AVE8062
Time frame: Cycle 1 : Day 1 and 2; up to Cycle 4 : Day 1
Pharmacokinetic parameters of cisplatin
Time frame: Day 1 to 4 of Cycle 1
Pharmacokinetic parameters of AVE8062's active metabolite RPR258063
Time frame: Cycle 1 : Day 1 and 2; up to Cycle 4 : Day 1
Objective tumor response as defined by the Response Evaluation Criteria in Solid Tumors (RECIST v1.1)
Time frame: up to a maximum of 11 months
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