NCT01021150

Dose Escalation, Safety and Pharmacokinetic Study of AVE8062 Combined With Cisplatin in Patients With Solid Tumors

An Open Label, Dose Escalation, Safety and Pharmacokinetics Phase 1 Study With Ombrabulin Administered as a 30-minute Intravenous Infusion in Combination With Cisplatin Administered as an Intravenous Infusion Every 3 Weeks in Patients With Advanced Solid Tumors

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 12 (estimated)
• Sponsor: Sanofi · Industry
• Sex: All
• Age: 20 Years – 75 Years
• Healthy volunteers: Not accepted

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 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.

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.

Conditions

• Neoplasms, Malignant

Interventions

Type	Name	Description
DRUG	ombrabulin (AVE8062)	Pharmaceutical form:injection solution Route of administration: intravenous infusion
DRUG	cisplatin	Pharmaceutical form: injection solution Route of administration: intravenous infusion

Timeline

• Start date: 2010-03-01
• Primary completion: 2011-05-01
• Completion: 2011-05-01
• First posted: 2009-11-26
• Last updated: 2011-06-13

Locations

1 site across 1 country: Japan