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

NCT01263886 | Completed Phase 2

• 3 other identifiers: EFC102592010-019384-11U1111-1115-3677
• Study Type: interventional
• Target: 176
• Locations: 13 countries
• Sites: 43

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.

Conditions

Non-small Cell Lung Cancer

Outcome Measures

Primary Outcomes (1)

• Progression free survival (PFS)

  approximately 1.5 years

Secondary Outcomes (2)

• Overall survival (OS)

  approximately 1.5 years

• Objective response rate (OR)

  approximately 1.5 years

Study Arms (2)

AVE8062 and combination

EXPERIMENTAL

Day 1: AVE8062 Day 2: docetaxel followed by cisplatin or paclitaxel followed by carboplatin

Drug: ombrabulin (AVE8062)

Placebo

PLACEBO COMPARATOR

Day 1: placebo Day 2: docetaxel followed by cisplatin or paclitaxel followed by carboplatin

Drug: placebo

Interventions

ombrabulin (AVE8062) DRUG

Pharmaceutical form:solution Route of administration: intravenous

AVE8062 and combination

placebo DRUG

Pharmaceutical form:solution Route of administration: intravenous

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Sanofi: lead

Study Sites (43)

Investigational Site Number 840001

Muscle Shoals, Alabama, 35661, United States

Location

Investigational Site Number 840003

Hot Springs, Arkansas, 71913, United States

Location

Investigational Site Number 840002

Anaheim, California, 92801, United States

Location

Investigational Site Number 840009

Modesto, California, 95355, United States

Location

Investigational Site Number 840005

Lansing, Michigan, 48912, United States

Location

Investigational Site Number 036002

Bendigo, 3550, Australia

Location

Investigational Site Number 036001

Southport, 4215, Australia

Location

Investigational Site Number 152005

Santiago, 751-0009, Chile

Location

Investigational Site Number 152002

Santiago, 7510032, Chile

Location

Investigational Site Number 152003

Santiago, 8380456, Chile

Location

Investigational Site Number 152004

Valparaíso, 2363058, Chile

Location

Investigational Site Number 191002

Zagreb, 10000, Croatia

Location

Investigational Site Number 191003

Zagreb, 10000, Croatia

Location

Investigational Site Number 191001

Zagreb, Croatia

Location

Investigational Site Number 250005

Bordeaux, 33076, France

Location

Investigational Site Number 250002

Dijon, 21034, France

Location

Investigational Site Number 250003

Lyon, 69373, France

Location

Investigational Site Number 250004

Nice, 06189, France

Location

Investigational Site Number 250001

Saint-Herblain, 44805, France

Location

Investigational Site Number 276001

Gauting, 82131, Germany

Location

Investigational Site Number 276002

Großhansdorf, 22927, Germany

Location

Investigational Site Number 276003

Immenhausen, 34376, Germany

Location

Investigational Site Number 380002

Genova, 16132, Italy

Location

Investigational Site Number 380003

Milan, 20132, Italy

Location

Investigational Site Number 380001

Monza, 20052, Italy

Location

Investigational Site Number 616003

Lublin, 20-954, Poland

Location

Investigational Site Number 616001

Poznan, 60-569, Poland

Location

Investigational Site Number 616004

Warsaw, 02-781, Poland

Location

Investigational Site Number 616005

Warsaw, 04-125, Poland

Location

Investigational Site Number 642002

Bucharest, 050098, Romania

Location

Investigational Site Number 642003

Cluj-Napoca, 400015, Romania

Location

Investigational Site Number 642004

Craiova, 200385, Romania

Location

Investigational Site Number 642001

Iași, 700106, Romania

Location

Investigational Site Number 643002

Moscow, 115478, Russia

Location

Investigational Site Number 643004

Saint Petersburg, 194291, Russia

Location

Investigational Site Number 688003

Belgrade, 11080, Serbia

Location

Investigational Site Number 688001

Kamenitz, 21204, Serbia

Location

Investigational Site Number 410003

Seoul, 110-744, South Korea

Location

Investigational Site Number 410002

Seoul, 120-752, South Korea

Location

Investigational Site Number 410001

Seoul, 135-710, South Korea

Location

Investigational Site Number 804001

Dnipropetrovsk, 49102, Ukraine

Location

Investigational Site Number 804003

Kyiv, 3022, Ukraine

Location

Investigational Site Number 804002

Sumy, 40003, Ukraine

Location

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Interventions

AC 7700

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Clinical Sciences & Operations

  Sanofi

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 14, 2010
• First Posted: December 21, 2010
• Study Start: February 1, 2011
• Primary Completion: March 1, 2012
• Study Completion: October 1, 2012
• Last Updated: December 21, 2015

Record last verified: 2015-11

Locations

KR (3); UA (3); CL (4); SE (2); DE (3); US (5); PL (4); CR (3); FR (5); AU (2); IT (3); RO (4); RU (2)