Trial Review

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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT01263886




Registration number
NCT01263886
Ethics application status
Date submitted
14/12/2010
Date registered
21/12/2010
Date last updated
21/12/2015

Titles & IDs
Public title
Trial of Ombrabulin (AVE8062) in Combination With Taxane and Platinum in Patients With Non-small Cell Lung Cancer
Scientific 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
Secondary ID [1] 0 0
2010-019384-11
Secondary ID [2] 0 0
EFC10259
Universal Trial Number (UTN)
Trial acronym
DISRUPT
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Non-small Cell Lung Cancer 0 0
Condition category
Condition code
Cancer 0 0 0 0
Lung - Mesothelioma
Cancer 0 0 0 0
Lung - Non small cell
Cancer 0 0 0 0
Lung - Small cell

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - ombrabulin (AVE8062)
Treatment: Drugs - placebo

Experimental: AVE8062 and combination - Day 1: AVE8062

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

Placebo comparator: Placebo - Day 1: placebo

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


Treatment: Drugs: ombrabulin (AVE8062)
Pharmaceutical form:solution

Route of administration: intravenous

Treatment: Drugs: placebo
Pharmaceutical form:solution

Route of administration: intravenous
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Progression free survival (PFS)
Timepoint [1] 0 0
approximately 1.5 years
Secondary outcome [1] 0 0
Overall survival (OS)
Timepoint [1] 0 0
approximately 1.5 years
Secondary outcome [2] 0 0
Objective response rate (OR)
Timepoint [2] 0 0
approximately 1.5 years

Eligibility
Key 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
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
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 design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s


The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 2
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/02/2011
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/10/2012
Sample size
Target
Accrual to date
Final
176
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
Investigational Site Number 036002 - Bendigo
Recruitment hospital [2] 0 0
Investigational Site Number 036001 - Southport
Recruitment postcode(s) [1] 0 0
3550 - Bendigo
Recruitment postcode(s) [2] 0 0
4215 - Southport
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Alabama
Country [2] 0 0
United States of America
State/province [2] 0 0
Arkansas
Country [3] 0 0
United States of America
State/province [3] 0 0
California
Country [4] 0 0
United States of America
State/province [4] 0 0
Michigan
Country [5] 0 0
Chile
State/province [5] 0 0
Santiago
Country [6] 0 0
Chile
State/province [6] 0 0
Valparaiso
Country [7] 0 0
Croatia
State/province [7] 0 0
Zagreb
Country [8] 0 0
France
State/province [8] 0 0
Bordeaux Cedex
Country [9] 0 0
France
State/province [9] 0 0
Dijon
Country [10] 0 0
France
State/province [10] 0 0
Lyon
Country [11] 0 0
France
State/province [11] 0 0
Nice Cedex 02
Country [12] 0 0
France
State/province [12] 0 0
Saint-Herblain Cedex
Country [13] 0 0
Germany
State/province [13] 0 0
Gauting
Country [14] 0 0
Germany
State/province [14] 0 0
Großhansdorf
Country [15] 0 0
Germany
State/province [15] 0 0
Immenhausen
Country [16] 0 0
Italy
State/province [16] 0 0
Genova
Country [17] 0 0
Italy
State/province [17] 0 0
Milano
Country [18] 0 0
Italy
State/province [18] 0 0
Monza
Country [19] 0 0
Korea, Republic of
State/province [19] 0 0
Seoul
Country [20] 0 0
Poland
State/province [20] 0 0
Lublin
Country [21] 0 0
Poland
State/province [21] 0 0
Poznan
Country [22] 0 0
Poland
State/province [22] 0 0
Warszawa
Country [23] 0 0
Romania
State/province [23] 0 0
Bucharest
Country [24] 0 0
Romania
State/province [24] 0 0
Cluj Napoca
Country [25] 0 0
Romania
State/province [25] 0 0
Craiova
Country [26] 0 0
Romania
State/province [26] 0 0
Iasi
Country [27] 0 0
Russian Federation
State/province [27] 0 0
Moscow
Country [28] 0 0
Russian Federation
State/province [28] 0 0
St-Petersburg
Country [29] 0 0
Serbia
State/province [29] 0 0
Belgrade
Country [30] 0 0
Serbia
State/province [30] 0 0
Sremska Kamenica
Country [31] 0 0
Ukraine
State/province [31] 0 0
Dnipropetrovsk
Country [32] 0 0
Ukraine
State/province [32] 0 0
Kyiv
Country [33] 0 0
Ukraine
State/province [33] 0 0
Sumy

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Sanofi
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Clinical Sciences & Operations
Address 0 0
Sanofi
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.

Results not provided in https://clinicaltrials.gov/study/NCT01263886