Trial of Ombrabulin (AVE8062) in Combination With Taxane and Platinum in Patients With Non-small Cell Lung Cancer
- Conditions
- Non-small Cell Lung Cancer
- Interventions
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 176
Not provided
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