E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
locally advanced or metastatic Non-Small-Cell Lung Cancer |
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MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 9.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10059515 |
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E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
To demonstrate progression free survival (PFS) improvement for ombrabulin compared to placebo, in combination with taxane andplatinum, as first line treatment for patients with locally advanced or metastatic non-small cell lung cancer (NSCLC). |
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E.2.2 | Secondary objectives of the trial |
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. |
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E.2.3 | Trial contains a sub-study | Yes |
E.2.3.1 | Full title, date and version of each sub-study and their related objectives |
FARMACOGENETICA: Versione:1 Data:2010/09/10 Titolo:Sottostudio opzionale di farmacogenetica Obiettivi:L`obiettivo principale del sottostudio opzionale di farmacogenetica e` di analizzare un gruppo di biomarcatori allo scopo di indentificare una potenziale firma predittiva di efficacia per la terapia con ombrabulin (AVE8062),in associazione con taxani e sali di platino. (per maggiori dettagli fare riferimento all`Appendice D)
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E.3 | Principal inclusion criteria |
• Histologically proven locally advanced or metastatic non-small cell lung cancer (stage IV, according to Tumor, Nodes, Metastasis (TNM) classification 7th 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 |
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E.4 | Principal 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 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) Exclusion criteria related to ombrabulin 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 thrombo-embolism 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 orangiocardiography 12-lead Electrocardiogram (ECG): Infarction Q-wave, ST segment depression or elevation ≥1 mm in at least 2 contiguous leads |
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E.5 End points |
E.5.1 | Primary end point(s) |
Progression free survival (PFS) |
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | Yes |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | Yes |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | Yes |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | Yes |
E.6.13.1 | Other scope of the trial description |
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E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | Yes |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | No |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | No |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | Yes |
E.8.1.5 | Parallel group | Yes |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | No |
E.8.2.2 | Placebo | Yes |
E.8.2.3 | Other | No |
E.8.3 |
The trial involves single site in the Member State concerned
| No |
E.8.4 | The trial involves multiple sites in the Member State concerned | Yes |
E.8.4.1 | Number of sites anticipated in Member State concerned | 3 |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.5.1 | Number of sites anticipated in the EEA | 20 |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | Yes |
E.8.6.2 | Trial being conducted completely outside of the EEA | Information not present in EudraCT |
E.8.6.3 | If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned |
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E.8.7 | Trial has a data monitoring committee | No |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 2 |
E.8.9.1 | In the Member State concerned months | 0 |
E.8.9.1 | In the Member State concerned days | 0 |