E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Solid Tumors |
Tumores sólidos |
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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 |
Los tumores sólidos son masas de tejido con crecimiento anormal que se originan en organos o tejidos blandos y que no incluyen areas liquidas y quistes |
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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 | 18.0 |
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) |
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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 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 |
- Proporcionar tratamiento continuo con onartuzumab y/o el tratamiento de control designado en el ensayo P-a pacientes con cáncer incluidos anteriormente en un ensayo P de onartuzumab promovido por Roche/Genentech y que se hayan beneficiado del tratamiento administrado en dicho ensayo, según la evaluación del investigador responsable. - Recabar datos de seguridad sobre la administración de un tratamiento continuo con onartuzumab. |
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E.2.2 | Secondary objectives of the trial |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
- Enrolled and receiving either control treatment 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 15 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 90 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 90 days after the last dose of study drug and agreement to refrain from donating sperm during this same period |
-Inclusión y recepción del tratamiento de control o del tratamiento del estudio basado en onartuzumab en un ensayo P elegible -Incumplimiento de los criterios de suspensión del tratamiento especificados en el protocolo de su ensayo P en el momento de la inscripción en ensayo E -Capacidad para iniciar el tratamiento en el protocolo de extensión en los 15 días siguientes al último día del estudio en el protocolo anterior -En las mujeres que no sean posmenopáusicas (12 meses de amenorrea no inducida con tratamiento) o quirúrgicamente estériles (ausencia de los ovarios o el útero): aceptación de no mantener relaciones sexuales o de utilizar uno o varios métodos anticonceptivos no hormonales con una tasa de fallos de <1% al año durante el período de tratamiento y durante al menos 90 días después de la última dosis del fármaco del estudio -En el caso de los varones: aceptación de no mantener relaciones sexuales o de usar un preservativo más otro método anticonceptivo que en conjunto tengan una tasa de fallos <1% al año durante el periodo de tratamiento y durante al menos 90 días después de la última dosis del fármaco del estudio y aceptación de no donar semen durante este mismo periodo |
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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 |
-Embarazo o lactancia o intención de concebir durante el estudio (se requiere una prueba de embarazo en suero antes de la inclusión) -Cualquier tratamiento antineoplásico que no sea el del protocolo, iniciado entre la suspensión del tratamiento en el ensayo P y el comienzo de la inscripción en el ensayo E. |
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E.5 End points |
E.5.1 | Primary end point(s) |
Incidence of serious adverse events considered related to onartuzumab |
Acontecimientos adversos graves que se consideren relacionados con onartuzumab |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
Up to 2 years |
Hasta un máximo de 2 años |
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E.5.2 | Secondary end point(s) |
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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 | 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 |
Proporcionar tratamiento continuo con onartuzumab y/o el tratamiento de control designado en el ensayo P-a pacientes con cáncer incluidos anteriormente en un ensayo P de onartuzumab promovido por Roche/Genentech y que se hayan beneficiado del tratamiento administrado en dicho ensayo, según la evaluación del investigador responsable. |
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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) | 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
| 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 | 2 |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.5.1 | Number of sites anticipated in the EEA | 8 |
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 | No |
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 |
France |
Italy |
Japan |
Korea, Republic of |
Latvia |
Malaysia |
Poland |
Russian Federation |
Serbia |
South Africa |
Spain |
United States |
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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 | |
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 |