E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated | Patients who have been treated in previous AG-013736 oncology studies. | Pazienti già trattati con AG-013736 in precedenti sperimentazioni cliniche oncologiche | |
E.1.1.1 | Medical condition in easily understood language | Various solid tumor types | Vari tipi di tumore solido | |
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 | 10065143 | E.1.2 | Term | Malignant solid tumour | E.1.2 | System Organ Class | 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) | |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 14.1 | E.1.2 | Level | SOC | E.1.2 | Classification code | 10029104 | E.1.2 | Term | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | 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 | The objective of the trial is to provide continued access to AG-013736 tablets to patients who were assigned to an AG-013736-containing treatment arm in a previous AG-013736 trial and who had documented stable or responding disease at the time they discontinued in the trial. Continuing access will be provided to patients who have Progressive Disease (PD) but have experienced clinical benefit from previous AG-013736 treatment; in this case, clinical benefit is defined as the Sum of Longest Diameters (SLD) of measurable lesions remaining less than or equal to the baseline SLD in the previous AG-013736 trial. These patients must not be eligible for treatment with other available approved therapy for the disease under study. | L’obiettivo della sperimentazione è di fornire un trattamento con AG-013736 in compresse a pazienti randomizzati in un braccio di trattamento contenente AG-013736 in un precedente studio clinico con la molecola con malattia stabile documentata o responsiva nel momento in cui hanno interrotto la sperimentazione. Il trattamento continuo sarà fornito a pazienti con malattia in progressione (PD), ma che hanno ricevuto un beneficio clinico dal precedente trattamento con AG-013736. In tal caso, si definisce beneficio clinico la somma dei diametri più lunghi (SLD) delle lesioni misurabili residue che sono rimaste inferiori o pari alla SLD basale nella precedente sperimentazione con AG-013736. Tali pazienti non devono essere eleggibili ad un trattamento con altre terapie approvate e disponibili per la patologia in studio. | |
E.2.2 | Secondary objectives of the trial | Not applicable | non applicabile | |
E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria | Subjects must meet all of the following inclusion criteria to be eligible for enrollment into the trial: Patients who were assigned to an AG-013736-containing treatment arm in a previous clinical trial. Patients who were receiving AG-013736 tablets at the time their previous trial ended. Patients who have stable (SD) or responding disease (PR or CR) documented by the appropriate radiological, clinical, or laboratory assessments within 12 weeks before enrollment (Note: response criteria from the previous AG-013736 protocol should be used to determine stable or responding disease). Patients who have Progressive Disease (PD) but have experienced clinical benefit from previous AG-013736 treatment will be eligible for enrollment; in this case, clinical benefit is defined as the Sum of Longest Diameters (SLD) of measurable lesions remaining less than or equal to the baseline SLD in the previous AG-013736 trial. These patients must not be eligible for treatment with other available approved therapy for the disease under study. The Pfizer clinician must approve the enrollment prior to treatment start. Patients who are informed of, and willing and able to comply with the investigational nature of the trial, and have signed a written informed consent in accordance with institutional and ICH GCP guidelines. | I soggetti devono soddisfare tutti i seguenti criteri di inclusione per essere considerati eleggibili all’arruolamento nello studio: • Pazienti stati randomizzati ad un braccio di trattamento contenente AG-013736 in una precedente sperimentazione clinica. • Pazienti trattati con AG-013736 in compresse al momento della conclusione della loro precedente sperimentazione clinica. • Pazienti in malattia stabile (SD) o responsiva (PR o CR) documentata da opportuni esami radiologici, clinici e di laboratorio entro 12 settimane prima dell’arruolamento (Nota: Per determinare se la patologia sia stabile o responsiva, devono essere utilizzati i criteri di risposta del precedente protocollo con AG-013736). • I pazienti in progressione di malattia (PD), ma che hanno ricevuto un beneficio clinico dal precedente trattamento con AG-013736 ; in tal caso, si definisce beneficio clinico la somma dei diametri più lunghi (SLD) di lesioni misurabili residue inferiori o pari alla SLD basale nella precedente sperimentazione con AG-013736. Tali pazienti devono risultare non eleggibili ad un trattamento con altre terapie disponibili approvate per la patologia in studio. Il clinico di Pfizer deve approvare l’arruolamento prima dell’inizio del trattamento. • Pazienti disposti a rispettare l’aspetto sperimentale dello studio, in grado di farlo, ne siano stati informati ed abbiano firmato un consenso informato scritto in conformità alle linee guida istituzionali e delle ICH –GCP. | |
E.4 | Principal exclusion criteria | Subjects presenting with any of the following will not be included in the trial: Patients may not participate in this trial if the conditions for continuing treatment in the previous AG-013736 protocol are not met. | I pazienti che presentano qualsiasi dei seguenti aspetti non saranno inclusi nello studio: • Pazienti che non abbiano le condizioni per continuare il trattamento del precedente protocollo con AG-013736. | |
E.5 End points |
E.5.1 | Primary end point(s) | All patients will be assessed for safety by monitoring adverse events and laboratory values per standard clinical practice. Response to therapy will not be evaluated. | In tutti i pazienti verrà valutato il profilo di sicurezza monitorando gli eventi avversi ed i parametri di laboratorio secondo la pratica clinica standard. Non sarà valutata la risposta alla terapia. | |
E.5.1.1 | Timepoint(s) of evaluation of this end point | All patients will be assessed for safety by monitoring adverse events and laboratory values per standard clinical practice. Response to therapy will not be evaluated. | In tutti i pazienti verrà valutato il profilo di sicurezza monitorando gli eventi avversi ed i parametri di laboratorio secondo la pratica clinica standard. Non sarà valutata la risposta alla terapia. | |
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 | Yes |
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 | Continuation study for patients previously receiving AG-013736 in clinical trials | studio di estensione per pazienti precedentemente trattati con AG-013736 in studi clinici | |
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 | No |
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) | 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 | 0 |
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 | 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 | 4 |
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 | |
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 | End of trial in all participating countries is defined as the time at which all patients enrolled in the study have completed treatment on study. | La fine delle sperimentazione in tutti i paesi partecipanti è definito come il momento in cui tutti i pazienti arruolati nello studio hanno completato il trattamento di studio | |
E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 12 |
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 | 12 |
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 |