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

Phase 1

Completed

• Conditions: Neoplasms, Malignant
• Interventions: Drug: ombrabulin (AVE8062); Drug: cisplatin

• Registration Number: NCT01021150
• Lead Sponsor: Sanofi

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 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.

Study Timeline

• Study First Submitted: 2009-11-24
• Study First Submitted QC: 2009-11-25
• Study First Posted: 2009-11-26
• Study Start: 2010-03
• Primary Completion: 2011-05
• Study Completion: 2011-05
• Status Verified: 2011-06
• Last Update Submitted: 2011-06-10
• Last Update Posted: 2011-06-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 12

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Ombrabulin/cisplatin	ombrabulin (AVE8062)	AVE8062 combined with 75 mg/m2 of cisplatin will be administered once in every 3 weeks, with 30-minute intravenous infusion
Ombrabulin/cisplatin	cisplatin	AVE8062 combined with 75 mg/m2 of cisplatin will be administered once in every 3 weeks, with 30-minute intravenous infusion

Primary Outcome Measures

Name	Time	Method
Dose limiting toxicity	3 weeks (cycle 1)

Secondary Outcome Measures

Name	Time	Method
Global safety profile based on treatment emergent adverse events, serious adverse events, and laboratory abnormalities	on-treatment period + 30 days
Pharmacokinetic parameters of AVE8062	Cycle 1 : Day 1 and 2; up to Cycle 4 : Day 1
Pharmacokinetic parameters of cisplatin	Day 1 to 4 of Cycle 1
Pharmacokinetic parameters of AVE8062's active metabolite RPR258063	Cycle 1 : Day 1 and 2; up to Cycle 4 : Day 1
Objective tumor response as defined by the Response Evaluation Criteria in Solid Tumors (RECIST v1.1)	up to a maximum of 11 months

Trial Locations

Locations (1)

Sanofi-Aventis Administrative Office; 🇯🇵 Tokyo, Japan