The primary objective of the study is to determine the maximum tolerated dose (MTD) based on the incidence of dose limiting toxicity (DLT) and the maximum administered dose (MAD) of ombrabulin combined with paclitaxel and carboplatin administered every 3 weeks in patients with advanced solid tumors. Secondary Objectives: * To assess the overall safety profiles of the combination therapy * To characterize the pharmacokinetic profile of ombrabulin, its active metabolite RPR 258063, paclitaxel, and carboplatin when used in combination * To document the objective tumor response
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.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
18
Pharmaceutical form:solution Route of administration: intravenous
Pharmaceutical form:solution Route of administration: intravenous
Pharmaceutical form:solution Route of administration: intravenous
Investigational Site Number 392002
Akashi-Shi, Japan
Investigational Site Number 392001
Hidaka-Shi, Japan
The number of of drug related adverse events meeting the defined dose limiting toxicity at Cycle 1
Time frame: 3 weeks
The number of treatment emergent adverse events
Time frame: 30 days after the last injection
The number of serious adverse events
Time frame: 30 days after the last injection
The number of laboratory abnormalities
Time frame: 30 days after the last injection
Pharmacokinetic parameter of ombrabulin: Cmax
Time frame: Day 1-2 at Cycle 1
Pharmacokinetic parameter of RPR258063: tmax
Time frame: Day 1-2 at Cycle 1
Pharmacokinetic parameter of paclitaxel: Cmax
Time frame: Day 1-3 at Cycle 1
Pharmacokinetic parameter of carboplatin (free and total platinum): Cmax
Time frame: Day 1-3 at Cycle 1
Investigator determination of response
Time frame: 30 days after the last injection
Pharmacokinetic parameter of ombrabulin: AUC
Time frame: Day 1-2 at Cycle 1
Pharmacokinetic parameter of ombrabulin: CL
Time frame: Day 1-2 at Cycle 1
Pharmacokinetic parameter of ombrabulin: Vss
Time frame: Day 1-2 at Cycle 1
Pharmacokinetic parameter of ombrabulin: t 1/2
Time frame: Day 1-2 at Cycle 1
Pharmacokinetic parameter of RPR258063: Cmax
Time frame: Day 1-2 at Cycle 1
Pharmacokinetic parameter of RPR258063: AUC
Time frame: Day 1-2 at Cycle 1
Pharmacokinetic parameter of RPR258063: t 1/2
Time frame: Day 1-2 at Cycle 1
Pharmacokinetic parameter of RPR258063: Metabolic Ratio
Time frame: Day 1-2 at Cycle 1
Pharmacokinetic parameter of paclitaxel: AUC
Time frame: Day 1-3 at Cycle 1
Pharmacokinetic parameter of paclitaxel: CL
Time frame: Day 1-3 at Cycle 1
Pharmacokinetic parameter of paclitaxel: Vss
Time frame: Day 1-3 at Cycle 1
Pharmacokinetic parameter of paclitaxel: t 1/2
Time frame: Day 1-3 at Cycle 1
Pharmacokinetic parameter of carboplatin (free and total platinum): AUC
Time frame: Day 1-3 at Cycle 1
Pharmacokinetic parameter of carboplatin (free and total platinum): CL
Time frame: Day 1-3 at Cycle 1
Pharmacokinetic parameter of carboplatin (free and total platinum): Vss
Time frame: Day 1-3 at Cycle 1
Pharmacokinetic parameter of carboplatin (free and total platinum): t 1/2
Time frame: Day 1-3 at Cycle 1
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