Dose-escalation, Safety, Pharmacokinetics Study of AVE8062 Combined With Bevacizumab in Patients With Advanced Solid Tumors

Phase 1

Completed

• Conditions: Neoplasms, Malignant
• Interventions: Drug: Ombrabulin (AVE8062); Drug: bevacizumab

• Registration Number: NCT01193595
• Lead Sponsor: Sanofi

Brief Summary

Primary Objective:

- To determine the maximum administered dose (MAD) and the maximum tolerated dose (MTD) of ombrabulin in combination with best tolerated dose of bevacizumab based on the incidence of related Dose Limiting Toxicities (DLTs).

Secondary Objectives:

* To assess the overall safety profile of the combination

* To characterize the pharmacokinetic (PK) profile of both ombrabulin and bevacizumab when given in combination

* To evaluate preliminary evidence of anti-tumor activity

* To assess the pharmacodynamic effect using (Dynamic Contrast Enhanced Ultra-Sound) DCE-US, measuring biomarkers

Detailed Description

The duration of the study for each patient will include an up to 28-day screening phase, 21-day study treatment cycles, an end of treatment visit with a follow-up period. Each patient will participate in only one dose group and will receive AVE8062 with bevacizumab every 3 weeks until disease progression or unacceptable toxicities, withdrawal of consent or Investigator's decision.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2010-08-31
• Study Start: 2010-09
• Study First Submitted QC: 2010-09-01
• Study First Posted: 2010-09-02
• Primary Completion: 2014-10
• Study Completion: 2014-10
• Status Verified: 2014-12
• Last Update Submitted: 2014-12-02
• Last Update Posted: 2014-12-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 39

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
AVE8062/ bevacizumab	Ombrabulin (AVE8062)	The combination of ombrabulin and bevacizumab will be administered every 3 weeks according to the following schedule: One day 1, ombrabulin will be administered as a 30 minutes intravenous (i.v) infusion. Bevacizumab will be administered as a 30-90 minutes i.v. infusion 24 hours after the end of ombrabulin infusion on day 2.
AVE8062/ bevacizumab	bevacizumab	The combination of ombrabulin and bevacizumab will be administered every 3 weeks according to the following schedule: One day 1, ombrabulin will be administered as a 30 minutes intravenous (i.v) infusion. Bevacizumab will be administered as a 30-90 minutes i.v. infusion 24 hours after the end of ombrabulin infusion on day 2.

Primary Outcome Measures

Name	Time	Method
Incidence of Dose Limiting Toxicities (DLTs) that will define the MTD	3 weeks

Secondary Outcome Measures

Name	Time	Method
Pharmacokinetic parameters of ombrabulin	6 weeks
Overall safety profile of the combination	up to a maximum follow-up of 1 year
Pharmacokinetic parameters of bevacizumab	6 weeks
Preliminary evidence of antitumor activity according to Response Evaluation Criteria in Solid Tumors (RECIST 1.1)	up to a maximum follow-up of 1 year
Pharmacodynamic effect (biomarkers)	cycle 1

Trial Locations

Locations (4)

Investigational Site Number 380002; 🇮🇹 Milano, Italy

Investigational Site Number 380001; 🇮🇹 Milano, Italy

Investigational Site Number 250001; 🇫🇷 Villejuif Cedex, France

Investigational Site Number 826001; 🇬🇧 Sutton, United Kingdom