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

Completed · Phase 2 · Has a placebo group

Conditions studied: Non-small Cell Lung Cancer

In brief

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.

Key facts

Study ID

NCT01263886

Run by

Sanofi

People needed

176

Starts

2011-02-01

Expected to finish

2012-10-01

Last updated by the study team

2015-12-21

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Histologically proven squamous metastatic non-small cell lung cancer (stage IV, according to Tumor Nodes Metastasis (TNM) classification seventh edition)
• 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

You may not qualify if…

• Prior chemotherapy, immunotherapy or targeted therapy for lung cancer disease (including adjuvant/neoadjuvant therapy)
• 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.

Where it is running

• 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

Full record on ClinicalTrials.gov

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