Trial of Ombrabulin (AVE8062) in Combination With Taxane and Platinum in Patients With Non-small Cell Lung Cancer
NCT ID: NCT01263886
Last Updated: 2015-12-21
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
176 participants
INTERVENTIONAL
2011-02-28
2012-10-31
Brief Summary
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* 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
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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AVE8062 and combination
Day 1: AVE8062
Day 2: docetaxel followed by cisplatin or paclitaxel followed by carboplatin
ombrabulin (AVE8062)
Pharmaceutical form:solution
Route of administration: intravenous
Placebo
Day 1: placebo
Day 2: docetaxel followed by cisplatin or paclitaxel followed by carboplatin
placebo
Pharmaceutical form:solution
Route of administration: intravenous
Interventions
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ombrabulin (AVE8062)
Pharmaceutical form:solution
Route of administration: intravenous
placebo
Pharmaceutical form:solution
Route of administration: intravenous
Eligibility Criteria
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Inclusion Criteria
* Patients with measurable disease, Response Evaluation Criteria In Solid Tumors (RECIST) criteria (version 1.1)
* Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1
Exclusion Criteria
* History of brain metastases, uncontrolled spinal cord compression, or carcinomatous meningitis
* History of another neoplasm. Adequately treated basal cell or squamous skin cancer, or in situ cervical cancer, or any other cancer from which the patient has been disease-free for \>5 years are allowed
* Participation in another clinical trial and any concurrent treatment with any investigational drug within 30 days prior to randomization
* Acquired immunodeficiency syndrome (AIDS-related illness) or known human immunodeficiency virus (HIV) disease requiring antiretroviral treatment
* Any severe acute or chronic medical condition, which could impair the ability of the patient to participate in the study or interfere with interpretation of study results
* Pregnant or breast-feeding woman. Positive serum or urine pregnancy test prior to randomization
* Patient with reproductive potential (Male/Female) who do not agree to use accepted and effective method of contraception during the study treatment period and for at least 3 months after the completion of the study treatment. The definition of "effective method of contraception" will be based on the investigator's judgment
* Inadequate organ function
* Pre-existing peripheral neuropathy \> grade 1 according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) V.4.03
* Pre-existing hearing impairment \> grade 2
* Known hypersensitivity due to taxanes and /or polysorbate 80 or any other compound of the study drug combination
* Other serious illness or medical conditions such as (but not restricted): Active infection, Superior vena cava syndrome, Pericardial effusion requiring intervention (drainage)
* Documented medical history of myocardial infarction, documented angina pectoris, arrhythmia especially severe conduction disorder such as second or third-degree atrioventricular block, stroke, or history of arterial or venous thromboembolism within the past 6 months still requiring anticoagulants.
* Uncontrolled hypertension within 3 months prior to study treatment or patient with organ damage related to hypertension.
* Patient with Left Ventricular Ejection Fraction (LVEF) value lower than institution inferior normal limit, evaluated by echocardiography or angiocardiography
* 12-lead Electrocardiogram (ECG): Infarction Q-wave, ST segment depression or elevation ≥1 mm in at least 2 contiguous leads
* History of gross hemoptysis (i.e. 1/2 teaspoon of red blood or more per episode) within the past 1 month.
* Has non-squamous NSCLC(adenocarcinoma/large cell or other)
The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
18 Years
ALL
No
Sponsors
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Sanofi
INDUSTRY
Responsible Party
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Principal Investigators
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Clinical Sciences & Operations
Role: STUDY_DIRECTOR
Sanofi
Locations
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Investigational Site Number 840001
Muscle Shoals, Alabama, United States
Investigational Site Number 840003
Hot Springs, Arkansas, United States
Investigational Site Number 840002
Anaheim, California, United States
Investigational Site Number 840009
Modesto, California, United States
Investigational Site Number 840005
Lansing, Michigan, United States
Investigational Site Number 036002
Bendigo, , Australia
Investigational Site Number 036001
Southport, , Australia
Investigational Site Number 152005
Santiago, , Chile
Investigational Site Number 152002
Santiago, , Chile
Investigational Site Number 152003
Santiago, , Chile
Investigational Site Number 152004
Valparaíso, , Chile
Investigational Site Number 191002
Zagreb, , Croatia
Investigational Site Number 191003
Zagreb, , Croatia
Investigational Site Number 191001
Zagreb, , Croatia
Investigational Site Number 250005
Bordeaux, , France
Investigational Site Number 250002
Dijon, , France
Investigational Site Number 250003
Lyon, , France
Investigational Site Number 250004
Nice, , France
Investigational Site Number 250001
Saint-Herblain, , France
Investigational Site Number 276001
Gauting, , Germany
Investigational Site Number 276002
Großhansdorf, , Germany
Investigational Site Number 276003
Immenhausen, , Germany
Investigational Site Number 380002
Genova, , Italy
Investigational Site Number 380003
Milan, , Italy
Investigational Site Number 380001
Monza, , Italy
Investigational Site Number 616003
Lublin, , Poland
Investigational Site Number 616001
Poznan, , Poland
Investigational Site Number 616004
Warsaw, , Poland
Investigational Site Number 616005
Warsaw, , Poland
Investigational Site Number 642002
Bucharest, , Romania
Investigational Site Number 642003
Cluj-Napoca, , Romania
Investigational Site Number 642004
Craiova, , Romania
Investigational Site Number 642001
Iași, , Romania
Investigational Site Number 643002
Moscow, , Russia
Investigational Site Number 643004
Saint Petersburg, , Russia
Investigational Site Number 688003
Belgrade, , Serbia
Investigational Site Number 688001
Kamenitz, , Serbia
Investigational Site Number 410003
Seoul, , South Korea
Investigational Site Number 410002
Seoul, , South Korea
Investigational Site Number 410001
Seoul, , South Korea
Investigational Site Number 804001
Dnipropetrovsk, , Ukraine
Investigational Site Number 804003
Kyiv, , Ukraine
Investigational Site Number 804002
Sumy, , Ukraine
Countries
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Other Identifiers
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2010-019384-11
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
U1111-1115-3677
Identifier Type: OTHER
Identifier Source: secondary_id
EFC10259
Identifier Type: -
Identifier Source: org_study_id