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Non-small Cell Lung CancerPhase 2DISRUPTNCT01263886

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

A Phase 2 study testing ombrabulin (AVE8062) in people with Non-small Cell Lung Cancer, run by Sanofi at 43 sites in 13 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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). Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Non-small Cell Lung Cancer
What is being tested?
ombrabulin (AVE8062)
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
176 participants
Where
43 sitesin 13 countries
Study dates
Feb 2011to Oct 2012
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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
Show all 20Show fewer
  • 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.

Trial locations and contacts

43 sites in 13 countries.

43 sites in 13 countries

United States5 sites

  • Investigational Site Number 840002

    Anaheim, California, 92801

  • Investigational Site Number 840003

    Hot Springs, Arkansas, 71913

  • Investigational Site Number 840005

    Lansing, Michigan, 48912

  • Investigational Site Number 840009

    Modesto, California, 95355

  • Investigational Site Number 840001

    Muscle Shoals, Alabama, 35661

Other trials in United States

France5 sites

  • Investigational Site Number 250005

    Bordeaux, 33076

  • Investigational Site Number 250002

    Dijon, 21034

  • Investigational Site Number 250003

    Lyon, 69373

  • Investigational Site Number 250004

    Nice, 06189

  • Investigational Site Number 250001

    Saint-Herblain, 44805

Other trials in France

Chile4 sites

  • Investigational Site Number 152005

    Santiago, 751-0009

  • Investigational Site Number 152002

    Santiago, 7510032

  • Investigational Site Number 152003

    Santiago, 8380456

  • Investigational Site Number 152004

    Valparaíso, 2363058

Other trials in Chile

Poland4 sites

  • Investigational Site Number 616003

    Lublin, 20-954

  • Investigational Site Number 616001

    Poznan, 60-569

  • Investigational Site Number 616004

    Warsaw, 02-781

  • Investigational Site Number 616005

    Warsaw, 04-125

Other trials in Poland

Romania4 sites

  • Investigational Site Number 642002

    Bucharest, 050098

  • Investigational Site Number 642003

    Cluj-Napoca, 400015

  • Investigational Site Number 642004

    Craiova, 200385

  • Investigational Site Number 642001

    Iași, 700106

Other trials in Romania

Croatia3 sites

  • Investigational Site Number 191002

    Zagreb, 10000

  • Investigational Site Number 191003

    Zagreb, 10000

  • Investigational Site Number 191001

    Zagreb

Other trials in Croatia

Germany3 sites

  • Investigational Site Number 276001

    Gauting, 82131

  • Investigational Site Number 276002

    Großhansdorf, 22927

  • Investigational Site Number 276003

    Immenhausen, 34376

Other trials in Germany

Italy3 sites

  • Investigational Site Number 380002

    Genova, 16132

  • Investigational Site Number 380003

    Milan, 20132

  • Investigational Site Number 380001

    Monza, 20052

Other trials in Italy

South Korea3 sites

  • Investigational Site Number 410003

    Seoul, 110-744

  • Investigational Site Number 410002

    Seoul, 120-752

  • Investigational Site Number 410001

    Seoul, 135-710

Other trials in South Korea

Ukraine3 sites

  • Investigational Site Number 804001

    Dnipropetrovsk, 49102

  • Investigational Site Number 804003

    Kyiv, 3022

  • Investigational Site Number 804002

    Sumy, 40003

Other trials in Ukraine

Australia2 sites

  • Investigational Site Number 036002

    Bendigo, 3550

  • Investigational Site Number 036001

    Southport, 4215

Other trials in Australia

Russia2 sites

  • Investigational Site Number 643002

    Moscow, 115478

  • Investigational Site Number 643004

    Saint Petersburg, 194291

Other trials in Russia

Serbia2 sites

  • Investigational Site Number 688003

    Belgrade, 11080

  • Investigational Site Number 688001

    Kamenitz, 21204

Other trials in Serbia

About this study

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

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.
Read the 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.

Being tested
ombrabulin (AVE8062), placebo
Medical subject headings
Carcinoma, Non-Small-Cell Lung

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • ombrabulin (AVE8062)Drug

    Pharmaceutical form:solution

    Route of administration: intravenous

  • placeboDrug

    Pharmaceutical form:solution

    Route of administration: intravenous

Study groups in NCT01263886
Study groupRoleWhat they receive
AVE8062 and combinationExperimentalDay 1: AVE8062 Day 2: docetaxel followed by cisplatin or paclitaxel followed by carboplatin
Receives: Drug: ombrabulin (AVE8062)
PlaceboPlacebo comparatorDay 1: placebo Day 2: docetaxel followed by cisplatin or paclitaxel followed by carboplatin
Receives: Drug: placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Progression free survival (PFS)

    Measured: approximately 1.5 years

Secondary outcomes (2)

  1. Overall survival (OS)

    Measured: approximately 1.5 years

  2. Objective response rate (OR)

    Measured: approximately 1.5 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted21 Dec 2010 (estimated)
  2. Study startFeb 2011
  3. Primary completionMar 2012
  4. Study completionOct 2012

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
176 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01263886
Sponsor's protocol ID
EFC10259
Other IDs
2010-019384-11, U1111-1115-3677
Acronym
DISRUPT
Status last verified
Nov 2015
First submitted
14 Dec 2010
Last updated
21 Dec 2015
Results posted
No
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing ombrabulin (AVE8062) in people with Non-small Cell Lung Cancer, run by Sanofi at 43 sites in 13 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 20 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 21 Dec 2015. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 43 sites in United States, France, Chile, Poland, Romania and 8 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Progression free survival (PFS) (time frame: approximately 1.5 years). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01263886.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Dec 2015.

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