Trial of Ombrabulin (AVE8062) in Combination With Taxane and Platinum in Patients With Non-small Cell Lung Cancer

Phase 2

Completed

• Conditions: Non-small Cell Lung Cancer
• Interventions: Drug: ombrabulin (AVE8062); Drug: placebo

• Registration Number: NCT01263886
• Lead Sponsor: Sanofi

Brief Summary

Primary Objective:

* To demonstrate progression free survival (PFS) improvement for ombrabulin compared to placebo, in combination with taxane and platinum, as first line treatment for patients with metastatic non-small cell lung cancer (NSCLC).

Secondary Objective:

* To determine overall survival (OS), overall response rate (ORR) according to Response Evaluation Criteria In Solid Tumors (RECIST) criteria, safety, and evaluate potential biomarkers, pharmacokinetic (PK) analysis of ombrabulin and its main metabolite, RPR258063, using a population approach.

Detailed Description

Patients will be treated for a maximum of 6 cycles (21 days each), in the absence of unacceptable toxicity or disease progression or consent withdrawal. All patients will be followed for disease progression documentation and for patient status until up to one year after the primary analysis cutoff date.

Study Timeline

• Study First Submitted: 2010-12-14
• Study First Submitted QC: 2010-12-17
• Study First Posted: 2010-12-21
• Study Start: 2011-02
• Primary Completion: 2012-03
• Study Completion: 2012-10
• Status Verified: 2015-11
• Disposition First Submitted: 2015-11-18
• Disposition First Submitted QC: 2015-11-18
• Last Update Submitted: 2015-11-18
• Disposition First Posted: 2015-12-21
• Last Update Posted: 2015-12-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 176

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
AVE8062 and combination	ombrabulin (AVE8062)	Day 1: AVE8062 Day 2: docetaxel followed by cisplatin or paclitaxel followed by carboplatin
Placebo	placebo	Day 1: placebo Day 2: docetaxel followed by cisplatin or paclitaxel followed by carboplatin

Primary Outcome Measures

Name	Time	Method
Progression free survival (PFS)	approximately 1.5 years

Secondary Outcome Measures

Name	Time	Method
Objective response rate (OR)	approximately 1.5 years
Overall survival (OS)	approximately 1.5 years

Trial Locations

Locations (43)

Investigational Site Number 840009; 🇺🇸 Modesto, California, United States

Investigational Site Number 152003; 🇨🇱 Santiago, Chile

Investigational Site Number 250002; 🇫🇷 Dijon, France

Investigational Site Number 380002; 🇮🇹 Genova, Italy

Investigational Site Number 840003; 🇺🇸 Hot Springs, Arkansas, United States

Investigational Site Number 036002; 🇦🇺 Bendigo, Australia

Investigational Site Number 036001; 🇦🇺 Southport, Australia

Investigational Site Number 250005; 🇫🇷 Bordeaux Cedex, France

Investigational Site Number 250003; 🇫🇷 Lyon, France

Investigational Site Number 250004; 🇫🇷 Nice Cedex 02, France

Investigational Site Number 250001; 🇫🇷 Saint-Herblain Cedex, France

Investigational Site Number 276001; 🇩🇪 Gauting, Germany

Investigational Site Number 276002; 🇩🇪 Großhansdorf, Germany

Investigational Site Number 276003; 🇩🇪 Immenhausen, Germany

Investigational Site Number 380001; 🇮🇹 Monza, Italy

Investigational Site Number 380003; 🇮🇹 Milano, Italy

Investigational Site Number 410001; 🇰🇷 Seoul, Korea, Republic of

Investigational Site Number 616004; 🇵🇱 Warszawa, Poland

Investigational Site Number 152004; 🇨🇱 Valparaiso, Chile

Investigational Site Number 191002; 🇭🇷 Zagreb, Croatia

Investigational Site Number 642003; 🇷🇴 Cluj Napoca, Romania

Investigational Site Number 152005; 🇨🇱 Santiago, Chile

Investigational Site Number 152002; 🇨🇱 Santiago, Chile

Investigational Site Number 191001; 🇭🇷 Zagreb, Croatia

Investigational Site Number 191003; 🇭🇷 Zagreb, Croatia

Investigational Site Number 616001; 🇵🇱 Poznan, Poland

Investigational Site Number 616005; 🇵🇱 Warszawa, Poland

Investigational Site Number 616003; 🇵🇱 Lublin, Poland

Investigational Site Number 642002; 🇷🇴 Bucharest, Romania

Investigational Site Number 642001; 🇷🇴 Iasi, Romania

Investigational Site Number 643004; 🇷🇺 St-Petersburg, Russian Federation

Investigational Site Number 688003; 🇷🇸 Belgrade, Serbia

Investigational Site Number 804001; 🇺🇦 Dnipropetrovsk, Ukraine

Investigational Site Number 643002; 🇷🇺 Moscow, Russian Federation

Investigational Site Number 642004; 🇷🇴 Craiova, Romania

Investigational Site Number 688001; 🇷🇸 Sremska Kamenica, Serbia

Investigational Site Number 804003; 🇺🇦 Kyiv, Ukraine

Investigational Site Number 804002; 🇺🇦 Sumy, Ukraine

Investigational Site Number 410003; 🇰🇷 Seoul, Korea, Republic of

Investigational Site Number 410002; 🇰🇷 Seoul, Korea, Republic of

Investigational Site Number 840001; 🇺🇸 Muscle Shoals, Alabama, United States

Investigational Site Number 840002; 🇺🇸 Anaheim, California, United States

Investigational Site Number 840005; 🇺🇸 Lansing, Michigan, United States