Clinical trial NCT01263886: Trial of Ombrabulin (AVE8062) in Combination With Taxane and Platinum in Patients With Non-small Cell Lung Cancer
Official title: A Multinational, Randomized, Double Blind, Controlled Phase II Trial of Ombrabulin With Taxane and Platinum Combination Administered Every Three Weeks, in First Line Treatment of Patients Metastatic Non-small Cell Lung Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Non-small Cell Lung Cancer
Lead sponsor: Sanofi
Sponsor class: INDUSTRY
First posted: 2010-12-21
Enrollment: 176
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: Inclusion criteria:

* 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

Exclusion criteria:

* 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.

Primary outcomes:
measure: Progression free survival (PFS)
timeFrame: approximately 1.5 years
Secondary outcomes:
measure: Overall survival (OS)
timeFrame: approximately 1.5 years
measure: Objective response rate (OR)
timeFrame: approximately 1.5 years
Other outcomes:
Locations:
city: Muscle Shoals
country: United States
facility: Investigational Site Number 840001
state: Alabama
city: Hot Springs
country: United States
facility: Investigational Site Number 840003
state: Arkansas
city: Anaheim
country: United States
facility: Investigational Site Number 840002
state: California
city: Modesto
country: United States
facility: Investigational Site Number 840009
state: California
city: Lansing
country: United States
facility: Investigational Site Number 840005
state: Michigan
city: Bendigo
country: Australia
facility: Investigational Site Number 036002
city: Southport
country: Australia
facility: Investigational Site Number 036001
city: Santiago
country: Chile
facility: Investigational Site Number 152005
city: Santiago
country: Chile
facility: Investigational Site Number 152002
city: Santiago
country: Chile
facility: Investigational Site Number 152003
city: Valparaiso
country: Chile
facility: Investigational Site Number 152004
city: Zagreb
country: Croatia
facility: Investigational Site Number 191002
city: Zagreb
country: Croatia
facility: Investigational Site Number 191003
city: Zagreb
country: Croatia
facility: Investigational Site Number 191001
city: Bordeaux Cedex
country: France
facility: Investigational Site Number 250005
city: Dijon
country: France
facility: Investigational Site Number 250002
city: Lyon
country: France
facility: Investigational Site Number 250003
city: Nice Cedex 02
country: France
facility: Investigational Site Number 250004
city: Saint-Herblain Cedex
country: France
facility: Investigational Site Number 250001
city: Gauting
country: Germany
facility: Investigational Site Number 276001
city: Großhansdorf
country: Germany
facility: Investigational Site Number 276002
city: Immenhausen
country: Germany
facility: Investigational Site Number 276003
city: Genova
country: Italy
facility: Investigational Site Number 380002
city: Milano
country: Italy
facility: Investigational Site Number 380003
city: Monza
country: Italy
facility: Investigational Site Number 380001
city: Seoul
country: Korea, Republic of
facility: Investigational Site Number 410003
city: Seoul
country: Korea, Republic of
facility: Investigational Site Number 410002
city: Seoul
country: Korea, Republic of
facility: Investigational Site Number 410001
city: Lublin
country: Poland
facility: Investigational Site Number 616003
city: Poznan
country: Poland
facility: Investigational Site Number 616001
city: Warszawa
country: Poland
facility: Investigational Site Number 616004
city: Warszawa
country: Poland
facility: Investigational Site Number 616005
city: Bucharest
country: Romania
facility: Investigational Site Number 642002
city: Cluj Napoca
country: Romania
facility: Investigational Site Number 642003
city: Craiova
country: Romania
facility: Investigational Site Number 642004
city: Iasi
country: Romania
facility: Investigational Site Number 642001
city: Moscow
country: Russian Federation
facility: Investigational Site Number 643002
city: St-Petersburg
country: Russian Federation
facility: Investigational Site Number 643004
city: Belgrade
country: Serbia
facility: Investigational Site Number 688003
city: Sremska Kamenica
country: Serbia
facility: Investigational Site Number 688001
city: Dnipropetrovsk
country: Ukraine
facility: Investigational Site Number 804001
city: Kyiv
country: Ukraine
facility: Investigational Site Number 804003
city: Sumy
country: Ukraine
facility: Investigational Site Number 804002
Study officials:
affiliation: Sanofi
name: Clinical Sciences & Operations
role: STUDY_DIRECTOR
References: