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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01263886
Recruitment Status : Completed
First Posted : December 21, 2010
Last Update Posted : December 21, 2015
Information provided by (Responsible Party):

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.

Condition or disease Intervention/treatment Phase
Non-small Cell Lung Cancer Drug: ombrabulin (AVE8062) Drug: placebo Phase 2

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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 176 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
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 Start Date : February 2011
Actual Primary Completion Date : March 2012
Actual Study Completion Date : October 2012

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lung Cancer

Arm Intervention/treatment
Experimental: AVE8062 and combination

Day 1: AVE8062

Day 2: docetaxel followed by cisplatin or paclitaxel followed by carboplatin

Drug: ombrabulin (AVE8062)

Pharmaceutical form:solution

Route of administration: intravenous

Placebo Comparator: Placebo

Day 1: placebo

Day 2: docetaxel followed by cisplatin or paclitaxel followed by carboplatin

Drug: placebo

Pharmaceutical form:solution

Route of administration: intravenous

Primary Outcome Measures :
  1. Progression free survival (PFS) [ Time Frame: approximately 1.5 years ]

Secondary Outcome Measures :
  1. Overall survival (OS) [ Time Frame: approximately 1.5 years ]
  2. Objective response rate (OR) [ Time Frame: approximately 1.5 years ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01263886

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Sponsors and Collaborators
Study Director: Clinical Sciences & Operations Sanofi

Responsible Party: Sanofi Identifier: NCT01263886     History of Changes
Other Study ID Numbers: EFC10259
2010-019384-11 ( EudraCT Number )
U1111-1115-3677 ( Other Identifier: UTN )
First Posted: December 21, 2010    Key Record Dates
Last Update Posted: December 21, 2015
Last Verified: November 2015

Additional relevant MeSH terms:
Lung Neoplasms
Carcinoma, Non-Small-Cell Lung
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Lung Diseases
Respiratory Tract Diseases
Carcinoma, Bronchogenic
Bronchial Neoplasms
Antineoplastic Agents