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 docetaxel and 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, docetaxel 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
11
Pharmaceutical form:injection solution Route of administration: intravenous infusion
Pharmaceutical form:injection solution Route of administration: intravenous infusion
Pharmaceutical form:injection solution Route of administration: intravenous infusion
Investigational Site Number 392003
Akashi-Shi, Japan
Investigational Site Number 392001
Kōtoku, Japan
Investigational Site Number 392002
Nagoya, 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 profiles of all study drugs and AVE8062 active metabolite based on PK parameters (Cmax, AUC, t1/2, CL, Vss).
Time frame: Cycle 1: Day 1 and 3; up to Cycle 4: Day 1
Objective tumor response as defined by the Response Evaluation Criteria in Solid Tumors (RECIST v1.1)
Time frame: on-treatment period + 30 days
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