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

November 18, 2015 updated by: Sanofi

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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

Enrollment (Actual)

176

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Australia
      • Bendigo, Australia, 3550
        • Investigational Site Number 036002
      • Southport, Australia, 4215
        • Investigational Site Number 036001
  • Chile
      • Santiago, Chile, 751-0009
        • Investigational Site Number 152005
      • Santiago, Chile, 7510032
        • Investigational Site Number 152002
      • Santiago, Chile, 8380456
        • Investigational Site Number 152003
      • Valparaiso, Chile, 2363058
        • Investigational Site Number 152004
  • Croatia
      • Zagreb, Croatia
        • Investigational Site Number 191001
      • Zagreb, Croatia, 10000
        • Investigational Site Number 191002
      • Zagreb, Croatia, 10000
        • Investigational Site Number 191003
  • France
      • Bordeaux Cedex, France, 33076
        • Investigational Site Number 250005
      • Dijon, France, 21034
        • Investigational Site Number 250002
      • Lyon, France, 69373
        • Investigational Site Number 250003
      • Nice Cedex 02, France, 06189
        • Investigational Site Number 250004
      • Saint-Herblain Cedex, France, 44805
        • Investigational Site Number 250001
  • Germany
      • Gauting, Germany, 82131
        • Investigational Site Number 276001
      • Großhansdorf, Germany, 22927
        • Investigational Site Number 276002
      • Immenhausen, Germany, 34376
        • Investigational Site Number 276003
  • Italy
      • Genova, Italy, 16132
        • Investigational Site Number 380002
      • Milano, Italy, 20132
        • Investigational Site Number 380003
      • Monza, Italy, 20052
        • Investigational Site Number 380001
  • Korea, Republic of
      • Seoul, Korea, Republic of, 120-752
        • Investigational Site Number 410002
      • Seoul, Korea, Republic of, 110-744
        • Investigational Site Number 410003
      • Seoul, Korea, Republic of, 135-710
        • Investigational Site Number 410001
  • Poland
      • Lublin, Poland, 20-954
        • Investigational Site Number 616003
      • Poznan, Poland, 60-569
        • Investigational Site Number 616001
      • Warszawa, Poland, 02-781
        • Investigational Site Number 616004
      • Warszawa, Poland, 04-125
        • Investigational Site Number 616005
  • Romania
      • Bucharest, Romania, 050098
        • Investigational Site Number 642002
      • Cluj Napoca, Romania, 400015
        • Investigational Site Number 642003
      • Craiova, Romania, 200385
        • Investigational Site Number 642004
      • Iasi, Romania, 700106
        • Investigational Site Number 642001
  • Russian Federation
      • Moscow, Russian Federation, 115478
        • Investigational Site Number 643002
      • St-Petersburg, Russian Federation, 194291
        • Investigational Site Number 643004
  • Serbia
      • Belgrade, Serbia, 11080
        • Investigational Site Number 688003
      • Sremska Kamenica, Serbia, 21204
        • Investigational Site Number 688001
  • Ukraine
      • Dnipropetrovsk, Ukraine, 49102
        • Investigational Site Number 804001
      • Kyiv, Ukraine, 3022
        • Investigational Site Number 804003
      • Sumy, Ukraine, 40003
        • Investigational Site Number 804002
  • United States
    • Alabama
      • Muscle Shoals, Alabama, United States, 35661
        • Investigational Site Number 840001
    • Arkansas
      • Hot Springs, Arkansas, United States, 71913
        • Investigational Site Number 840003
    • California
      • Anaheim, California, United States, 92801
        • Investigational Site Number 840002
      • Modesto, California, United States, 95355
        • Investigational Site Number 840009
    • Michigan
      • Lansing, Michigan, United States, 48912
        • Investigational Site Number 840005

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Progression free survival (PFS)
Time Frame: approximately 1.5 years
approximately 1.5 years

Secondary Outcome Measures

Outcome Measure
Time Frame
Overall survival (OS)
Time Frame: approximately 1.5 years
approximately 1.5 years
Objective response rate (OR)
Time Frame: approximately 1.5 years
approximately 1.5 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sanofi

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2011

Primary Completion (Actual)

March 1, 2012

Study Completion (Actual)

October 1, 2012

Study Registration Dates

First Submitted

December 14, 2010

First Submitted That Met QC Criteria

December 17, 2010

First Posted (Estimate)

December 21, 2010

Study Record Updates

Last Update Posted (Estimate)

December 21, 2015

Last Update Submitted That Met QC Criteria

November 18, 2015

Last Verified

November 1, 2015

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • EFC10259
  • 2010-019384-11 (EudraCT Number)
  • U1111-1115-3677 (Other Identifier: UTN)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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