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

Phase 1

Completed

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

• Registration Number: NCT01095302
• 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 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.

Study Timeline

• Study First Submitted: 2010-03-23
• Study First Submitted QC: 2010-03-29
• Study First Posted: 2010-03-30
• Study Start: 2010-05
• Primary Completion: 2011-12
• Study Completion: 2011-12
• Status Verified: 2013-10
• Last Update Submitted: 2013-10-12
• Last Update Posted: 2013-10-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 11

Inclusion Criteria

Not provided

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Ombrabulin/ docetaxel/cisplatin	OMBRABULIN (AVE8062)	AVE8062 combined with docetaxel and cisplatin will be administered once in every 3 weeks, with 30-minute intravenous infusion
Ombrabulin/ docetaxel/cisplatin	cisplatin	AVE8062 combined with docetaxel and cisplatin will be administered once in every 3 weeks, with 30-minute intravenous infusion
Ombrabulin/ docetaxel/cisplatin	docetaxel	AVE8062 combined with docetaxel and 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
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

Trial Locations

Locations (3)

Investigational Site Number 392001; 🇯🇵 Koto-Ku, Japan

Investigational Site Number 392003; 🇯🇵 Akashi-Shi, Japan

Investigational Site Number 392002; 🇯🇵 Nagoya-Shi, Japan