E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Patients affected by stage IIIB or stage IV NSCLC candidates to receive a first line chemotherapy with vinorelbine due to age ≥ 70 and Eastern Cooperative Oncology Group (ECOG) Performance status ≤2 or age ≤ 70 but ECOG PS ≥ 2 |
Pazienti affetti da neoplasia del polmone non a piccole cellule (NSCLC), stadio IIIB o IV, candidati a ricevere una chemioterapia di prima linea con vinorelbina con età ≥ 70 ed Eastern
Cooperative Oncology Group (ECOG) performance status ≤ 2 o di età ≤ 70, ma PS (ECOG) ≥ 2. |
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E.1.1.1 | Medical condition in easily understood language |
Patients with lung cancer, candidates to receive a first-line chemotherapy with vinorelbine with age ≥ 70 and in good condition or younger but with poor performance status |
Pazienti affetti da neoplasia del polmone candidati a ricevere una chemioterapia di prima linea con vinorelbina con età ≥ 70 e in buone condizioni o più giovani ma in condizioni scadute |
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E.1.1.2 | Therapeutic area | Diseases [C] - Cancer [C04] |
MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 15.0 |
E.1.2 | Level | PT |
E.1.2 | Classification code | 10029522 |
E.1.2 | Term | Non-small cell lung cancer stage IV |
E.1.2 | System Organ Class | 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) |
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E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 15.0 |
E.1.2 | Level | PT |
E.1.2 | Classification code | 10029521 |
E.1.2 | Term | Non-small cell lung cancer stage IIIB |
E.1.2 | System Organ Class | 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) |
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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 |
Patient preference for oral or intravenous vinorelbine, from the 3° cycle onwards |
determinazione della percentuale di pazienti che esprimano la preferenza per la via di somministrazione
orale (OS) della vinorelbina rispetto a quella endovenosa (IV), dal 3° ciclo di trattamento in poi. |
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E.2.2 | Secondary objectives of the trial |
Overall Response Rate, Time to Progression, Toxicity, Survival, Subjective reasons for treatment choice. |
- tasso di risposta (RR)
· sopravvivenza libera da progressione (PFS)
· sopravvivenza globale (OS)
· tossicità delle formulazioni orale ed endovenosa
· le ragioni della preferenza per la via di somministrazione orale o endovenosa. |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
Patients affected by stage IIIB or stage IV NSCLC candidates to receive a first line chemotherapy with vinorelbine due to age ≥ 70 and Eastern Cooperative Oncology Group (ECOG) Performance status ≤2 or age ≤ 70 but ECOG PS ≥ 2 |
Pazienti affetti da neoplasia del polmone non a piccole cellule (NSCLC), stadio IIIB o IV, candidati a ricevere una chemioterapia di prima linea con vinorelbina con età ≥ 70 ed Eastern
Cooperative Oncology Group (ECOG) performance status ≤ 2 o di età ≤ 70, ma PS (ECOG) ≥ 2. |
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E.4 | Principal exclusion criteria |
1. Patients who have had previous chemotherapy for lung cancer or radiotherapy on target lesions.
2. Participation in another clinical trial with any investigational agents within 30 days prior to study screening.
3. Presence of infection.
4. Preexisting clinically significant peripheral neuropathy. |
1. I pazienti che hanno ricevuto una precedente chemioterapia o radioterapia per la neoplasia ai polmoni.
2. La partecipazione a un altro studio clinico con farmaci sperimentali nei 30 giorni precedenti
le procedure di screening.
3. Presenza di infezione.
4. Preesistente neuropatia periferica clinicamente rilevante |
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E.5 End points |
E.5.1 | Primary end point(s) |
The primary objective of the study was to evaluate patient-reported preference for “oral” or “intravenous” vinorelbine. The primary endpoint was the percentage of patients who preferred the “oral” to the “intravenous” vinorelbine. |
L'obiettivo primario dello studio è valutare la preferenza riferita dal paziente per la vinorelbina "orale" o "endovenosa". L'endpoint primario è quindi la percentuale di pazienti che preferiscono la via di somministrazione "orale" a quella "endovenosa". |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
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E.5.2 | Secondary end point(s) |
Secondary endpoints are response rate (RR), progression-free survival (PFS), overall survival (OS) and toxicity of both drug formulations. The trial aims to evaluate subjective reasons for treatment choice. |
Gli endpoint secondari sono il tasso di risposta (RR), la sopravvivenza libera da progressione (PFS), la sopravvivenza globale (OS) e la tossicità di entrambe le formulazioni del farmaco. Lo studio si propone anche di valutare motivi soggettivi per la scelta del trattamento. |
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
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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 | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | No |
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 |
preference for the intravenous or oral route of administration |
preferenza per la via di somministrazione endovenosa o orale |
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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) | No |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | Yes |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | Yes |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | No |
E.8.1.5 | Parallel group | Yes |
E.8.1.6 | Cross over | Yes |
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 | No |
E.8.2.3 | Other | Yes |
E.8.2.3.1 | Comparator description |
stesso farmaco, ma diversa via di somministrazione - Stesso farmaco ad altro dosaggio |
same drug, but different route of administration - same IMP used at different dosage |
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E.8.2.4 | Number of treatment arms in the trial | 2 |
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 | 8 |
E.8.5 | The trial involves multiple Member States | No |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | No |
E.8.6.2 | Trial being conducted completely outside of the EEA | No |
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 | 0 |
E.8.9.1 | In the Member State concerned months | 24 |
E.8.9.1 | In the Member State concerned days | 0 |