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

Non-small Cell Lung Cancer Clinical Trial

— DISRUPT  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01263886
• Other study ID #: EFC10259
• Secondary ID: 2010-019384-11U1
• Status: Completed
• Phase: Phase 2
• First received: December 14, 2010
• Last updated: November 18, 2015
• Start date: February 2011
• Est. completion date: October 2012

Study information

• Verified date: November 2015
• Source: Sanofi
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical 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).

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 176
• Est. completion date: October 2012
• Est. primary completion date: March 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Carcinoma, Non-Small-Cell Lung
• Lung Neoplasms
• Non-small Cell Lung Cancer

Intervention

Drug:
• ombrabulin (AVE8062)
Pharmaceutical form:solution Route of administration: intravenous
• placebo
Pharmaceutical form:solution Route of administration: intravenous

Locations

Country	Name	City	State
Australia	Investigational Site Number 036002	Bendigo
Australia	Investigational Site Number 036001	Southport
Chile	Investigational Site Number 152002	Santiago
Chile	Investigational Site Number 152003	Santiago
Chile	Investigational Site Number 152005	Santiago
Chile	Investigational Site Number 152004	Valparaiso
Croatia	Investigational Site Number 191001	Zagreb
Croatia	Investigational Site Number 191002	Zagreb
Croatia	Investigational Site Number 191003	Zagreb
France	Investigational Site Number 250005	Bordeaux Cedex
France	Investigational Site Number 250002	Dijon
France	Investigational Site Number 250003	Lyon
France	Investigational Site Number 250004	Nice Cedex 02
France	Investigational Site Number 250001	Saint-Herblain Cedex
Germany	Investigational Site Number 276001	Gauting
Germany	Investigational Site Number 276002	Großhansdorf
Germany	Investigational Site Number 276003	Immenhausen
Italy	Investigational Site Number 380002	Genova
Italy	Investigational Site Number 380003	Milano
Italy	Investigational Site Number 380001	Monza
Korea, Republic of	Investigational Site Number 410001	Seoul
Korea, Republic of	Investigational Site Number 410002	Seoul
Korea, Republic of	Investigational Site Number 410003	Seoul
Poland	Investigational Site Number 616003	Lublin
Poland	Investigational Site Number 616001	Poznan
Poland	Investigational Site Number 616004	Warszawa
Poland	Investigational Site Number 616005	Warszawa
Romania	Investigational Site Number 642002	Bucharest
Romania	Investigational Site Number 642003	Cluj Napoca
Romania	Investigational Site Number 642004	Craiova
Romania	Investigational Site Number 642001	Iasi
Russian Federation	Investigational Site Number 643002	Moscow
Russian Federation	Investigational Site Number 643004	St-Petersburg
Serbia	Investigational Site Number 688003	Belgrade
Serbia	Investigational Site Number 688001	Sremska Kamenica
Ukraine	Investigational Site Number 804001	Dnipropetrovsk
Ukraine	Investigational Site Number 804003	Kyiv
Ukraine	Investigational Site Number 804002	Sumy
United States	Investigational Site Number 840002	Anaheim	California
United States	Investigational Site Number 840003	Hot Springs	Arkansas
United States	Investigational Site Number 840005	Lansing	Michigan
United States	Investigational Site Number 840009	Modesto	California
United States	Investigational Site Number 840001	Muscle Shoals	Alabama

Sponsors (1)

Lead Sponsor	Collaborator
Sanofi

Countries where clinical trial is conducted

United States,  Australia,  Chile,  Croatia,  France,  Germany,  Italy,  Korea, Republic of,  Poland,  Romania,  Russian Federation,  Serbia,  Ukraine, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Progression free survival (PFS)		approximately 1.5 years	No
Secondary	Overall survival (OS)		approximately 1.5 years	No
Secondary	Objective response rate (OR)		approximately 1.5 years	No