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

Sanofi1 site in 1 country12 target enrollmentMarch 2010

ConditionsNeoplasms, Malignant

Interventionsombrabulin (AVE8062)cisplatin

Drugsombrabulin (AVE8062)cisplatin

Overview

Phase: Phase 1
Intervention: ombrabulin (AVE8062)
Conditions: Neoplasms, Malignant
Sponsor: Sanofi
Enrollment: 12
Locations: 1
Primary Endpoint: Dose limiting toxicity
Status: Completed
Last Updated: 14 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

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 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.

Registry

clinicaltrials.gov

Start Date

March 2010

End Date

May 2011

Last Updated

14 years ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

Sanofi

Eligibility Criteria

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Arms & Interventions

Ombrabulin/cisplatin

AVE8062 combined with 75 mg/m2 of cisplatin will be administered once in every 3 weeks, with 30-minute intravenous infusion

Intervention: ombrabulin (AVE8062)

Ombrabulin/cisplatin

AVE8062 combined with 75 mg/m2 of cisplatin will be administered once in every 3 weeks, with 30-minute intravenous infusion

Intervention: cisplatin

Outcomes

Primary Outcomes

Dose limiting toxicity

Time Frame: 3 weeks (cycle 1)

Secondary Outcomes

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)