A Dose-escalation Study of Ombrabulin in Combination With Paclitaxel and Carboplatin in Patients With Advanced Solid Tumors
- Conditions
- Advanced Solid Tumors
- Interventions
- Registration Number
- NCT01293630
- Lead Sponsor
- Sanofi
- Brief Summary
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
- Detailed Description
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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 18
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Cohort - 1 through 5 Ombrabulin (AVE8062) AVE8062 combined with paclitaxel and carboplatin will be administered once every 3 weeks Cohort - 1 through 5 Paclitaxel AVE8062 combined with paclitaxel and carboplatin will be administered once every 3 weeks Cohort - 1 through 5 Carboplatin AVE8062 combined with paclitaxel and carboplatin will be administered once every 3 weeks
- Primary Outcome Measures
Name Time Method The number of of drug related adverse events meeting the defined dose limiting toxicity at Cycle 1 3 weeks
- Secondary Outcome Measures
Name Time Method Pharmacokinetic parameter of paclitaxel: Vss Day 1-3 at Cycle 1 Pharmacokinetic parameter of ombrabulin: AUC Day 1-2 at Cycle 1 Pharmacokinetic parameter of ombrabulin: Cmax Day 1-2 at Cycle 1 The number of laboratory abnormalities 30 days after the last injection Pharmacokinetic parameter of RPR258063: tmax Day 1-2 at Cycle 1 Pharmacokinetic parameter of carboplatin (free and total platinum): Cmax Day 1-3 at Cycle 1 Pharmacokinetic parameter of paclitaxel: CL Day 1-3 at Cycle 1 The number of treatment emergent adverse events 30 days after the last injection Pharmacokinetic parameter of ombrabulin: Vss Day 1-2 at Cycle 1 Pharmacokinetic parameter of paclitaxel: Cmax Day 1-3 at Cycle 1 Pharmacokinetic parameter of RPR258063: t 1/2 Day 1-2 at Cycle 1 Pharmacokinetic parameter of RPR258063: Metabolic Ratio Day 1-2 at Cycle 1 The number of serious adverse events 30 days after the last injection Investigator determination of response 30 days after the last injection Pharmacokinetic parameter of carboplatin (free and total platinum): t 1/2 Day 1-3 at Cycle 1 Pharmacokinetic parameter of ombrabulin: CL Day 1-2 at Cycle 1 Pharmacokinetic parameter of ombrabulin: t 1/2 Day 1-2 at Cycle 1 Pharmacokinetic parameter of RPR258063: Cmax Day 1-2 at Cycle 1 Pharmacokinetic parameter of RPR258063: AUC Day 1-2 at Cycle 1 Pharmacokinetic parameter of paclitaxel: t 1/2 Day 1-3 at Cycle 1 Pharmacokinetic parameter of carboplatin (free and total platinum): AUC Day 1-3 at Cycle 1 Pharmacokinetic parameter of carboplatin (free and total platinum): CL Day 1-3 at Cycle 1 Pharmacokinetic parameter of carboplatin (free and total platinum): Vss Day 1-3 at Cycle 1 Pharmacokinetic parameter of paclitaxel: AUC Day 1-3 at Cycle 1
Trial Locations
- Locations (2)
Investigational Site Number 392002
🇯🇵Akashi-Shi, Japan
Investigational Site Number 392001
🇯🇵Hidaka-Shi, Japan