| E.1 Medical condition or disease under investigation |
| E.1.1 | Medical condition(s) being investigated |
| Solid Tumors |
| tumori solidi |
|
| E.1.1.1 | Medical condition in easily understood language |
| Solid tumors are masses of abnormal tissue growth that originate in organs or soft tissues and do not include fluid areas and cysts |
| I tumori solidi sono masse caratterizzate da crescita anomala dei tessuti che si originano in organi o tessuti molli e non contengono aree liquide e cisti |
|
| 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 | 21.1 |
| E.1.2 | Level | PT |
| E.1.2 | Classification code | 10059515 |
| E.1.2 | Term | Non-small cell lung cancer metastatic |
| E.1.2 | System Organ Class | 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) |
|
| 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 provide continued onartuzumab and/or parent study (P study)-
designated control treatments to patients with cancer who were
previously enrolled in a Roche/Genentech-sponsored onartuzumab P
study and who derived benefit, as assessed by the responsible
investigator, from the therapy administered in the P study
¿To collect safety data with regard to administration of continued onartuzumab therapy |
Offrire la prosecuzione del trattamento con onartuzumab e/o dei trattamenti di controllo indicati nello studio principale (studio P) a pazienti affetti da tumore precedentemente arruolati in uno studio P su onartuzumab sponsorizzato da Roche/Genentech e che, in base alla valutazione dello sperimentatore responsabile, hanno tratto beneficio dalla terapia somministrata nello studio P
¿Raccogliere i dati sulla sicurezza relativamente alla prosecuzione della terapia con onartuzumab
|
|
| E.2.2 | Secondary objectives of the trial |
|
| E.2.3 | Trial contains a sub-study | No |
| E.3 | Principal inclusion criteria |
- Enrolled and receiving either control treatment and/or onartuzumab-based
study treatment in an eligible P study
- Has not met the treatment discontinuation criteria specified in their P
study protocol at the time of enrollment into the extension study (E
study)
- Ability to begin treatment in the extension (rollover) protocol within 42 days following the last day of the parent study
- For women who are not postmenopausal (>=12 months of non-
therapy-induced amenorrhea) or surgically sterile (absence of ovaries
and/or uterus): agreement to remain abstinent or use single or
combined non-hormonal contraceptive methods that result in a failure
rate of <1% per year during the treatment period and for at least 180
days after the last dose of study drug.
- For men: agreement to remain abstinent or use a condom plus an
additional contraceptive method that together result in a failure rate of <1% per year during the treatment period and for at least 180 days after
the last dose of study drug and agreement to refrain from donating sperm during this same period |
Arruolati e in terapia con trattamento di controllo e/o trattamento in studio basato su onartuzumab in uno studio P eleggibile
- Non soddisfano i criteri di interruzione del trattamento specificati nel proprio protocollo dello studio P al momento dell'arruolamento nello studio di estensione (studio E)
- Capacità di iniziare il trattamento del protocollo di estensione (rollover) entro 42 giorni dall'ultimo giorno dello studio principale
- Per le donne non in stato di post-menopausa (>=12 mesi di amenorrea non indotta da terapia) o chirurgicamente sterili (assenza di ovaie e/o utero): consenso a praticare l'astinenza o a utilizzare un metodo contraccettivo unico o non ormonale combinato che abbia un tasso di insuccesso <1% l'anno durante il periodo di trattamento e per almeno 180 giorni dopo l'ultima dose di farmaco in studio.
- Per gli uomini: consenso a praticare l'astinenza o a utilizzare un preservativo più un ulteriore metodo contraccettivo che nel complesso abbiano un tasso di insuccesso <1% l'anno durante il periodo di trattamento e per almeno 180 giorni dopo l'ultima dose di farmaco in studio e consenso ad astenersi dalla donazione di sperma durante lo stesso periodo
|
|
| E.4 | Principal exclusion criteria |
- Pregnancy or lactation or intention to become pregnant during the study (serum pregnancy test required before enrollment)
- Any non-protocol anti-cancer therapy started between discontinuation from treatment in P study and start of enrollment in E study |
Gravidanza o allattamento o intenzione di intraprendere una gravidanza durante lo studio (test di gravidanza su siero necessario prima dell'arruolamento)
- Qualsiasi terapia antitumorale estranea al protocollo iniziata tra l'interruzione del trattamento dello studio P e l'inizio dell'arruolamento nello studio E
|
|
| E.5 End points |
| E.5.1 | Primary end point(s) |
| Incidence of serious adverse events considered related to onartuzumab |
| Incidenza di eventi avversi seri considerati correlati a onartuzumab |
|
| E.5.1.1 | Timepoint(s) of evaluation of this end point |
| Up to 2 years |
| Fino a 2 anni |
|
| E.5.2 | Secondary end point(s) |
|
| E.5.2.1 | Timepoint(s) of evaluation of this end point |
|
| 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 | No |
| E.6.4 | Safety | Yes |
| E.6.5 | Efficacy | No |
| 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 |
To provide continued onartuzumab and/or parent study (P study)-
designated control treatments to patients with cancer who were
previously enrolled in a Roche/Genentech-sponsored onartuzumab P
study and who derived benefit, as assessed by the responsible
investigator, from the therapy administered in the P study |
| Offrire la prosecuzione del trattamento con onartuzumab e/o dei trattamenti di controllo indicati nello studio principale (studio P) a pazienti affetti da tumore precedentemente arruolati in uno studio P su onartuzumab sponsorizzato da Roche/Genentech e che, in base alla valutazione dello sperimentatore responsabile, hanno tratto beneficio dalla terapia somministrata nello studio P |
|
| 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) | Yes |
| E.7.4 | Therapeutic use (Phase IV) | No |
| E.8 Design of the trial |
| E.8.1 | Controlled | No |
| E.8.1.1 | Randomised | No |
| 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 | No |
| 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 | No |
| E.8.2.3 | Other | No |
| E.8.2.4 | Number of treatment arms in the trial | 1 |
| E.8.3 |
The trial involves single site in the Member State concerned
| Yes |
| E.8.4 | The trial involves multiple sites in the Member State concerned | No |
| E.8.4.1 | Number of sites anticipated in Member State concerned | 1 |
| E.8.5 | The trial involves multiple Member States | Yes |
| E.8.5.1 | Number of sites anticipated in the EEA | 7 |
| 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 |
| Japan |
| Korea, Democratic People's Republic of |
| Korea, Republic of |
| Malaysia |
| Russian Federation |
| Serbia |
| South Africa |
| United States |
| France |
| Italy |
| Lithuania |
| Poland |
| Spain |
|
| 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
|
The end of this study is defined as the date of the last patient, last visit (LPLV). This corresponds to 30 days after the last patient discontinues all treatment (either onartuzumab, control treatment, or both) for any
reason. Once patients have discontinued either control treatment and/or onartuzumab-based study treatment and completed a 30-day follow-up visit, their participation in the trial is considered complete.
|
| La fine dello studio ¿ definita come la data dell'ultima visita dell'ultimo paziente (LPLV). Questa corrisponde a 30 giorni dopo l'interruzione di tutti i trattamenti (onartuzumab, trattamento di controllo o entrambi) da parte dell'ultimo paziente per qualsiasi ragione. Quando i pazienti hanno interrotto il trattamento di controllo e/o il trattamento in studio a base di onartuzumab e hanno completato la visita di follow-up a 30 giorni, la loro partecipazione allo studio si considera completa. |
|
| 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 |
| E.8.9.2 | In all countries concerned by the trial years | 2 |
| E.8.9.2 | In all countries concerned by the trial months | 0 |
| E.8.9.2 | In all countries concerned by the trial days | 0 |
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