Clinical Trials/NCT01293630

NCT01293630

Completed

Phase 1

An Open-label, Dose-escalation, Safety and Pharmacokinetics Phase I Study of Ombrabulin in Combination With Paclitaxel and Carboplatin Every 3 Weeks in Patients With Advanced Solid Tumors

Sanofi2 sites in 1 country18 target enrollmentJanuary 2011

ConditionsAdvanced Solid Tumors

InterventionsOmbrabulin (AVE8062)Paclitaxel Carboplatin

DrugsOmbrabulin (AVE8062)Paclitaxel Carboplatin

Overview

Phase: Phase 1
Intervention: Ombrabulin (AVE8062)
Conditions: Advanced Solid Tumors
Sponsor: Sanofi
Enrollment: 18
Locations: 2
Primary Endpoint: The number of of drug related adverse events meeting the defined dose limiting toxicity at Cycle 1
Status: Completed
Last Updated: 10 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

January 2011

End Date

October 2013

Last Updated

10 years ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

Sanofi

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Arms & Interventions

Cohort - 1 through 5

AVE8062 combined with paclitaxel and carboplatin will be administered once every 3 weeks

Intervention: Ombrabulin (AVE8062)

Cohort - 1 through 5

AVE8062 combined with paclitaxel and carboplatin will be administered once every 3 weeks

Intervention: Paclitaxel

Cohort - 1 through 5

AVE8062 combined with paclitaxel and carboplatin will be administered once every 3 weeks

Intervention: Carboplatin

Outcomes

Primary Outcomes

The number of of drug related adverse events meeting the defined dose limiting toxicity at Cycle 1

Time Frame: 3 weeks

Secondary Outcomes

Pharmacokinetic parameter of ombrabulin: AUC(Day 1-2 at Cycle 1)
The number of laboratory abnormalities(30 days after the last injection)
Pharmacokinetic parameter of ombrabulin: Vss(Day 1-2 at Cycle 1)
Pharmacokinetic parameter of paclitaxel: CL(Day 1-3 at Cycle 1)
Pharmacokinetic parameter of carboplatin (free and total platinum): Cmax(Day 1-3 at Cycle 1)
The number of treatment emergent adverse events(30 days after the last injection)
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)
Pharmacokinetic parameter of paclitaxel: Vss(Day 1-3 at Cycle 1)
Pharmacokinetic parameter of ombrabulin: Cmax(Day 1-2 at Cycle 1)
Pharmacokinetic parameter of RPR258063: tmax(Day 1-2 at Cycle 1)
Pharmacokinetic parameter of paclitaxel: Cmax(Day 1-3 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)