E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
This Master Protocol for Crizotinib Continuation Sub-Studies has been designed to provide continued treatment access for eligible participants who continue to derive clinical benefit from study intervention in a Pfizer sponsored crizotinib parent study that will be closed |
Lo scopo di questo protocollo principale per i sottostudi di prosecuzione su crizotinib è di fornire un accesso continuativo al trattamento ai partecipanti idonei che continuano a trarre beneficio clinico dal trattamento dello studio in uno studio originario su crizotinib sponsorizzato da Pfizer che sarà chiuso |
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E.1.1.1 | Medical condition in easily understood language |
Not applicable |
Non applicabile |
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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 | 21.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10065252 |
E.1.2 | Term | Solid tumor |
E.1.2 | System Organ Class | 100000004864 |
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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 monitor safety of crizotinib Current sub-protocol (included in this submission) A8081013 - to monitor safety of crizotinib |
Monitorare la sicurezza di crizotinib Sottostudio A8081013 (incluso nella presente domanda) - Monitorare la sicurezza di crizotinib |
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E.2.2 | Secondary objectives of the trial |
Not applicable |
Non applicabile |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
1. Any participant who is receiving crizotinib and deriving clinical benefit (as determined by the investigator) in a Pfizer-sponsored Crizotinib Parent Study. 2. Participants must agree to follow the reproductive criteria as outlined in Appendix 4 (Section 10.4.1 for males and Section 10.4.2 for females). 3. No ongoing NCI CTCAE Grade =3 or intolerable Grade 2 AEs considered to be related to crizotinib treatment, except for those laboratory eligibility criteria described in Inclusion #4. 4. Adequate organ function as defined by the following criteria: Adults Participants (=18 years): • Hepatic function: Serum AST and serum ALT =3 × ULN, or AST and ALT =5 × ULN if liver function abnormalities were due to underlying malignancy; total serum bilirubin =1.5 × ULN (except participants with documented Gilbert's syndrome); • Bone marrow function: ANC =1000/µL, platelets =50,000/µL; hemoglobin =8.0 g/dL; • Stable renal function for at least 14 days. Pediatric Participants (<18 years): • Hepatic function defined as =3 × ULN for ALT and AST and =1.5 × ULN for bilirubin, or =5 × ULN for ALT and AST and =1.5 × ULN for bilirubin in case of liver involvement by metastases; • Adequate hematological function: • ANC =750/µL and platelets =75,000/µL for participants without bone marrow involvement; • Participants with bone marrow involvement will be allowed to enter with ANC =500/µL and platelets =50,000/µL; • Stable renal function for at least 14 days. |
1. Qualsiasi partecipante che stia ricevendo crizotinib e che ne tragga beneficio clinico (come determinato dallo sperimentatore) in uno studio originario su crizotinib sponsorizzato da Pfizer. 2. I partecipanti devono accettare di adottare i criteri riproduttivi di cui all’Appendice 4 (Sezione 10.4.1 per i partecipanti di sesso maschile e Sezione 10.4.2 per quelli di sesso femminile). 3. Nessun EA di grado =3 secondo i criteri NCI CTCAE o di grado 2 intollerabile considerato correlato al trattamento con crizotinib in corso, fatta eccezione per i criteri di eleggibilità di laboratorio descritti nell’Allegato n. 4. 4. Adeguata funzionalità d’organo definita dai seguenti criteri: Partecipanti adulti (=18 anni): • Funzione epatica: AST sierica e ALT sierica =3 × ULN, o AST e ALT =5 × ULN se le anomalie della funzionalità epatica erano dovute a tumore maligno sottostante; bilirubina sierica totale =1,5 × ULN (ad eccezione dei partecipanti con sindrome di Gilbert documentata); • Funzionalità del midollo osseo: ANC =1.000/µl, piastrine =50.000/µl; emoglobina =8,0 g/dl; • Funzione renale stabile per almeno 14 giorni. Partecipanti pediatrici (<18 anni): • Funzione epatica definita come =3 × ULN per ALT e AST e =1,5 × ULN per bilirubina, o =5 × ULN per ALT e AST e =1,5 × ULN per bilirubina in caso di coinvolgimento epatico con metastasi; • Adeguata funzione ematologica: • ANC =750/µl e piastrine =75.000/µl per i partecipanti senza coinvolgimento del midollo osseo; • Ai partecipanti con coinvolgimento del midollo osseo sarà consentito di entrare con ANC =500/µl e piastrine =50.000/µl; • Funzione renale stabile per almeno 14 giorni. |
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E.4 | Principal exclusion criteria |
1. Female participants who are pregnant or breastfeeding. 2. Any medical reason that, in the opinion of the investigator or sponsor, precludes the participant from inclusion in the study. |
1. Partecipanti di sesso femminile in gravidanza o che allattano al seno. 2. Qualsiasi motivo medico che, a giudizio dello sperimentatore o dello sponsor, precluda l’inclusione del partecipante nello studio. |
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E.5 End points |
E.5.1 | Primary end point(s) |
• AEs leading to permanent discontinuation of crizotinib • All SAEs |
• EA che determinano l’interruzione permanente del trattamento con crizotinib • Tutti i SAE |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
Not applicable |
Non applicabile |
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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 | 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 | 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 | Yes |
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 | Yes |
E.8.2.3.1 | Comparator description |
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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 | 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 | 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 |
China |
Japan |
Russian Federation |
Taiwan |
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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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The end of study for this Master Protocol is defined as when the last participant among the Crizotinib Continuation Sub-Studies has permanently discontinued from crizotinib, or 5 years after the first dose for the first participant of each Crizotinib Continuation Sub Study (whichever is sooner). |
La fine dello studio per questo protocollo principale è determinata quando l'ultimo partecipante tra gli studi secondari di continuazione di Crizotinib ha interrotto definitivamente crizotinib, o 5 anni dopo la prima dose per il primo partecipante di ogni sottostudio di continuazione di Crizotinib (a seconda di quale avvenga prima). |
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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 | 5 |
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 |