E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Non-Small Cell Lung Cancer (NSCLC) Renal Cell carcinoma (RCC) Hepatocellular carcinoma(HCC) |
Tumore non a piccole cellule Carcinoma Epatocellulare Carcinoma a cellule renali |
|
E.1.1.1 | Medical condition in easily understood language |
Non-Small Cell Lung Cancer (NSCLC) Renal Cell carcinoma (RCC) Hepatocellular carcinoma(HCC) |
Tumore non a piccole cellule Carcinoma Epatocellulare Carcinoma a cellule renali |
|
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 | 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) |
|
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 14.1 |
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) |
|
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 | 10038407 |
E.1.2 | Term | Renal cell cancer |
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 | LLT |
E.1.2 | Classification code | 10019828 |
E.1.2 | Term | Hepatocellular carcinoma non-resectable |
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 primary objective of this extension protocol is to provide subjects who participated in previous ARQ 197 studies that have reached their designated end-dates with uninterrupted access to ARQ 197 if, in the opinion of the Investigator and the Sponsor, they may benefit from the treatment. |
L'obiettivo principale dell'estensione del protocollo è fornire ai soggetti che hanno partecipato a precedenti studi con ARQ 197, e che hanno abbiano raggiunto le loro date finali designate e che, secondo il parere del medico dello studio e dello Sponsor, possano aver tratto beneficio dal trattamento con accesso ininterrotto al/ai farmaco/i in studio. |
|
E.2.2 | Secondary objectives of the trial |
The secondary objective of this study is to collect additional safety, tolerability and efficacy information for ARQ 197 treatment. |
L'obiettivo secondario dello studio è quello di raccogliere informazioni aggiuntive riguardo la sicurezza, la tollerabilità e l’efficacia di ARQ 197. |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
1. Signed written informed consent to Study ARQ 197-299 2. Male or female subjects of the age defined in the original protocol they were enrolled. 3. Eastern Cooperative Oncology Group (ECOG) performance status (PS) ≤3 4. Adequate bone marrow function: - Absolute neutrophil count (ANC) ≥1.5 x 10 to the 9th/L - Hemoglobin ≥8.0 g/dL 5. Enrollment within 14 days of the completion of End of Study Visit of the original study 6. Subjects, who participated in previous ARQ 197 studies that have reached their designated end-dates, who did not meet discontinuation criteria in their original study, and who may, in the opinion of the Investigator and the Sponsor, benefit from treatment 7. Women of childbearing potential must have a negative pregnancy test performed within 14 days of the start of study drug. Both men and women enrolled in this study must agree to use adequate birth control measures while on study |
1.Firma del consenso informato per lo studio ARQ 197-299 2. Soggetti maschi o femmine di età definita dal protocollo nel quale erano stati precedentemente arruolati. 3. Con un Eastern Cooperative Oncology Group (ECOG)performance status (PS) ≤3 4. Con un'adeguata funzione del midollo osseo: Una conta dei neutrofili completa (ANC) ≥1.5 x 10 per 9th/L Emoglobina ≥8.0 g/dL 5. Arruolamento entro 14 giorni dal completamento della visita di fine studio 6. Soggetti, che abbiano partecipato in uno studio precedente ARQ 197 e che abbiano raggiunto la data finale designata, che non abbiano raggiunto criteri di discontinuazione, e che hanno abbiano raggiunto le loro date finali designate e che, secondo il parere del medico dello studio e dello Sponsor, possano aver tratto beneficio dal trattamento con accesso ininterrotto al/ai farmaco/i in studio. 7.Le donne potenzialmente fertili devono avere un test negativo di gravidanza fatto nei 14 giorni precedenti all'inizio dell'assunzione del farmaco. Sia uomini che donne arruolati devono utilizzare misure adeguate per la prevenzione delle nascite. |
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E.4 | Principal exclusion criteria |
1. Known or suspected allergy to ARQ 197 2. Substance abuse, medical, psychological or social conditions that may interfere with the subject’s participation in the study or evaluation of the study results 3. Any condition that is unstable or which could jeopardize the safety of the subject and his/her compliance in the study 4. A serious uncontrolled medical disorder/condition that in the opinion of the Investigator would impair the ability of the subject to receive protocol therapy 5. Requirement to receive other concurrent chemotherapy (excluding combination therapy defined in original protocol), immunotherapy, radiotherapy, or any other investigational drug while on study. Palliative radiotherapy is allowed provided that: - in the opinion of the Investigator, the subject does not have progressive disease - the radiation field does not encompass a target lesion - no more than 10% of the subject’s bone marrow is irradiated E.5 Primary end point(s): This open label extension protocol will provide subjects who participated in previous ARQ197 studies that have reached their designed end-dates and who may have benefited from the treatment with uninterrupted access to the study drug. Avere i requisiti per ricevere altre chemioterapie concorrenti (escluse terapie combinate definite nel protocollo d'origine), immunoterapia, radioterapia, o qualsiasi altro farmaco investigativo durante lo studio. La radioterapia palliativa è permessa, a condizione che: - secondo l'opinione del medico dello studio, il soggetto non abbia avuto una progressione di malattia il campo della radiazione non comprenda una lesione bersaglio non piùdel 10% del midollo osseo del soggetto sia irradiato |
1. Allergia ad ARQ 197 risconosciuta o sospetta. 2. Abuso di sostanze, condizioni mediche, psicologiche o sociali che possano interferire con la partecipazione dei soggetti nello studio o nella valutazione dei risultati dello studio. 3. Alcuna condizione che sia instabile o che possa pregiudicare la sicurezza del soggetto o la sua compliance nello studio 4. Una malattia incontrollata/una condizione medica che, secondo il meidico dello studio possa compromettere la capacità del soggetto di ricevere la terapia del protocollo 5. |
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E.5 End points |
E.5.1 | Primary end point(s) |
This open label extension protocol will provide subjects who participated in previous ARQ197 studies that have reached their designed end-dates and who may have benefited from the treatment with uninterrupted access to the study drug. |
Questa estensione dello studio in aperto, fornirà ai soggetti che hanno partecipato a precedenti studi con ARQ 197 che hanno raggiunto il termine dello studio e che possono aver tratto beneficio dal trattamento con accesso ininterrotto al/ai farmaco/i in studio. |
|
E.5.1.1 | Timepoint(s) of evaluation of this end point |
Because of the nature of this study, no formal statistical analysis is planned. Analyses on all baseline, efficacy and safety. |
A causa della natura di questo studio, nessuna analisi statistica formale è prevista. Verranno svolte analisi sulla baseline, efficacia, la sicurezza. |
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E.5.2 | Secondary end point(s) |
|
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) | Yes |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
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) | 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 | Yes |
E.8.4.1 | Number of sites anticipated in Member State concerned | 4 |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.5.1 | Number of sites anticipated in the EEA | 1 |
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 |
Russian Federation |
United States |
|
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
|
Last patient last post-treatment safety follow up visit or phone call |
Ultimo paziente, ultimo post trattamento di follow-up di sicurezza dei pazienti ultima visita o una telefonata |
|
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 |