E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Solid tumours |
Tumores sólidos |
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E.1.1.1 | Medical condition in easily understood language |
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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 | 14.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10049280 |
E.1.2 | Term | Solid tumour |
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 | 14.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10065143 |
E.1.2 | Term | Malignant solid tumour |
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 bevacizumab therapy as single agent or in combination with an anti-cancer drug to patients with cancer, who were previously enrolled in a F. Hoffmann-La Roche (Roche)/ Genentech sponsored bevacizumab study (i.e. the Parent, P-trial) and who derived benefit from the therapy administered in the P-trial - To collect safety data with regard to long-term administration of bevacizumab |
- Proporcionar la continuación del tratamiento con bevacizumab en monoterapia o en combinación con un fármaco antineoplásico a pacientes con cáncer reclutados previamente en un estudio sobre el bevacizumab patrocinado por F. Hoffmann-La Roche (Roche)/Genentech (el ensayo principal, ensayo P) que se han beneficiado del tratamiento administrado en el ensayo P. - Recoger datos sobre seguridad con respecto a la administración a largo plazo del bevacizumab. |
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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 |
1. Written informed consent prior to any study-specific procedure. 2. Patient is treated with bevacizumab at the end of the Roche/Genentech sponsored P-trial and continues to have benefit as judged by the investigator 3. Eligible for continuation of bevacizumab treatment at the end of the Parent-trial, according to Parent-trial protocol 4. Able to comply with the Extension-trial protocol MO25757 5. Female patients should not be pregnant or breastfeeding. 6. Female patients of childbearing potential/fertile male patients must use a highly effective contraceptive method during the Extension-trial and for a period of at least 6 months following the last administration of Extension-trial drug(s). |
1. Antes de realizar ningún procedimiento específico del estudio deberá obtenerse el consentimiento informado por escrito. 2. El paciente está recibiendo tratamiento con bevacizumab al final del ensayo P patrocinado por Roche/Genentech y sigue obteniendo efectos beneficios según el criterio del investigador. 3. El paciente es elegible para continuar el tratamiento con bevacizumab al final del ensayo P, conforme al protocolo del ensayo P. 4. El paciente es capaz de cumplir el protocolo del ensayo E (MO25757). 5. Las mujeres no deben estar embarazadas ni en periodo de lactancia. 6. Las mujeres con capacidad de procrear / varones fértiles deberán utilizar un método anticonceptivo de alta eficacia durante el ensayo de extensión y durante al menos 6 meses después de la última dosis de la medicación del ensayo de extensión. |
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E.4 | Principal exclusion criteria |
1. Evidence of disease progression assessed according to Parent-trial protocol during the screening phase for this Extension-trial 2. Evidence of any adverse event potentially attributable to bevacizumab, for which the local label recommends permanent discontinuation. 3. A treatment interruption with bevacizumab of more than 42 days since the last administration of bevacizumab in the Parent-trial. 4. Evidence of any other disease, neurological or metabolic dysfunction, physical examination finding or laboratory finding giving reasonable suspicion of a disease or condition that contraindicates the use of the investigational drug(s) or puts the patient at high risk for treatment-related complications. |
1. Signos de progresión de la enfermedad evaluada conforme al protocolo del ensayo P durante la fase de selección para este ensayo E. 2. Signos de cualquier acontecimiento adverso potencialmente atribuible al bevacizumab por el que la ficha técnica local recomiende la interrupción definitiva de la administración. 3. Interrupción del tratamiento con bevacizumab durante más de 42 días desde la última dosis de bevacizumab en el ensayo P. 4. Signos de cualquier otra enfermedad, disfunción neurológica o metabólica, hallazgos en la exploración física o resultados analíticos que ofrezcan sospechas razonables de una enfermedad o trastorno que contraindique el uso de un fármaco en investigación o que implique un riesgo elevado para el paciente de sufrir complicaciones relacionadas con el tratamiento. |
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E.5 End points |
E.5.1 | Primary end point(s) |
Safety data (AE grade ?3 related to bevacizumab, SAEs, cause of deaths) |
Datos de seguridad (AA de grado ? 3 relacionado con el bevacizumab, AAG, causa de la muerte) |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
There will be a safety interim analysis approximately 3 years after the enrolment of the first patient in this Extension-trial. A final analyses will be done at the trial end. |
Se realizará un análisis intermedio de la seguridad aproximadamente 3 años después de la inclusión del primer paciente en este ensayo E. Al final del estudio se realizará un análisis final. |
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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 | 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 | No |
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 | No |
E.8.1.1 | Randomised | Information not present in EudraCT |
E.8.1.2 | Open | Information not present in EudraCT |
E.8.1.3 | Single blind | Information not present in EudraCT |
E.8.1.4 | Double blind | Information not present in EudraCT |
E.8.1.5 | Parallel group | Information not present in EudraCT |
E.8.1.6 | Cross over | Information not present in EudraCT |
E.8.1.7 | Other | Information not present in EudraCT |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | Information not present in EudraCT |
E.8.2.2 | Placebo | Information not present in EudraCT |
E.8.2.3 | Other | Information not present in EudraCT |
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 | 85 |
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 |
Argentina |
Australia |
Canada |
China |
Czech Republic |
Estonia |
Finland |
France |
Germany |
Greece |
Hong Kong |
Hungary |
Israel |
Italy |
Korea, Republic of |
Lithuania |
Mexico |
Netherlands |
Russian Federation |
Slovakia |
Spain |
United Kingdom |
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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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Study MO25757 will end 30 days after the last patient stops bevacizumab treatment |
El estudio MO25757 finalizará 30 días después de que el último paciente finalice el tratamiento con bevacizumab. |
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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 | 5 |
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 | 6 |
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 |