AVE8062 in Combination With Platinum-taxane Doublet in Advanced Solid Tumor

Phase 1

Completed

• Conditions: Neoplasms
• Interventions: Drug: OMBRABULIN (AVE8062)

• Registration Number: NCT00719524
• Lead Sponsor: Sanofi

Brief Summary

The purpose of this study is to determine the recommended dose of the combination of AVE8062 with platinum salts (cisplatin or carboplatin) and taxanes (docetaxel or paclitaxel) in patients with advanced solid tumors for which platinum-taxane doublet constitutes mainstay of care.

Detailed Description

Not available

Study Timeline

• Study Start: 2008-07
• Study First Submitted: 2008-07-17
• Study First Submitted QC: 2008-07-17
• Study First Posted: 2008-07-21
• Primary Completion: 2013-02
• Study Completion: 2013-02
• Status Verified: 2013-03
• Last Update Submitted: 2013-03-08
• Last Update Posted: 2013-03-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 71

Inclusion Criteria

• Advanced neoplastic disease (i.e. metastatic or locally advanced disease) for which platinum-taxane doublet regimens are approved or constitutes the mainstay of care such as non small cell lung cancer, epithelial ovary cancer, gastric cancer, transitional cell and bladder cancer and head and neck cancer.
• Eastern cooperative oncology group (ECOG) performance status of 0 to 1.

Exclusion Criteria

• Concurrent treatment with any other anticancer therapy, including chemotherapy, immunotherapy, radiotherapy (excluding radiotherapy with palliative intent on non-target lesions), targeted therapy, gene therapy, or patients planning to receive these treatments during the study.
• Absence of histologically or cytologically proven cancer at the first diagnosis.
• Negative serum/urinary pregnancy test
• Washout period of 3 weeks for prior anti-tumor therapy or any investigational treatment

The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
1	OMBRABULIN (AVE8062)	-

Primary Outcome Measures

Name	Time	Method
Recommended dose of the combination based on Dose Limiting Toxicities observed	Cycle 1

Secondary Outcome Measures

Name	Time	Method
Overall safety profile	Treatment period
Pharmacokinetic profile	Cycle 1
Anti-tumor activity of the combination	Every 2 cycles

Trial Locations

Locations (3)

Investigational Site Number 250001; 🇫🇷 Villejuif, France

Investigational Site Number 756001; 🇨🇭 Bellinzona, Switzerland

Investigational Site Number 380001; 🇮🇹 Milano, Italy