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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/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
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.
Trial website
https://clinicaltrials.gov/ct2/show/NCT01263886
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



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT01263886