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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


Phase 2
18 Years
N/A
Not Enrolling
Both
Non-small Cell Lung Cancer

Thank you

Trial Information

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


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.

Inclusion 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.

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Outcome Measure:

Progression free survival (PFS)

Outcome Time Frame:

approximately 1.5 years

Safety Issue:

No

Principal Investigator

Clinical Sciences & Operations

Investigator Role:

Study Director

Investigator Affiliation:

Sanofi

Authority:

United States: Food and Drug Administration

Study ID:

EFC10259

NCT ID:

NCT01263886

Start Date:

January 2011

Completion Date:

October 2012

Related Keywords:

  • Non-Small Cell Lung Cancer
  • Carcinoma, Non-Small-Cell Lung
  • Lung Neoplasms

Name

Location

Investigational Site Number 840001Muscle Shoals, Alabama  35661
Investigational Site Number 840003Hot Springs, Arkansas  71913
Investigational Site Number 840002Anaheim, California  92801
Investigational Site Number 840009Modesto, California  95355
Investigational Site Number 840005Lansing, Michigan  48912