An Open-label, Dose-escalation, Safety and Pharmacokinetics Phase I Study of Ombrabulin in Combination With Docetaxel and Cisplatin Every 3 Weeks in Patients With Advanced Solid Tumors
Overview
- Phase
- Phase 1
- Intervention
- OMBRABULIN (AVE8062)
- Conditions
- Neoplasms, Malignant
- Sponsor
- Sanofi
- Enrollment
- 11
- Locations
- 3
- Primary Endpoint
- Dose limiting toxicity
- Status
- Completed
- Last Updated
- 12 years ago
Overview
Brief Summary
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
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 30 days after the last infusion of ombrabulin. The patient will continue treatment until disease progression, unacceptable toxicity, patient's refusal of further treatment.
Investigators
Eligibility Criteria
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Arms & Interventions
Ombrabulin/ docetaxel/cisplatin
AVE8062 combined with docetaxel and cisplatin will be administered once in every 3 weeks, with 30-minute intravenous infusion
Intervention: OMBRABULIN (AVE8062)
Ombrabulin/ docetaxel/cisplatin
AVE8062 combined with docetaxel and cisplatin will be administered once in every 3 weeks, with 30-minute intravenous infusion
Intervention: cisplatin
Ombrabulin/ docetaxel/cisplatin
AVE8062 combined with docetaxel and cisplatin will be administered once in every 3 weeks, with 30-minute intravenous infusion
Intervention: docetaxel
Outcomes
Primary Outcomes
Dose limiting toxicity
Time Frame: 3 weeks (cycle 1)
Secondary Outcomes
- Pharmacokinetic profiles of all study drugs and AVE8062 active metabolite based on PK parameters (Cmax, AUC, t1/2, CL, Vss).(Cycle 1: Day 1 and 3; up to Cycle 4: Day 1)
- Global safety profile based on treatment emergent adverse events, serious adverse events, and laboratory abnormalities(on-treatment period + 30 days)
- Objective tumor response as defined by the Response Evaluation Criteria in Solid Tumors (RECIST v1.1)(on-treatment period + 30 days)