E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Acute myeloid leukemia (AML), myelodysplastic syndromes (MDS), and chronic myelomonocytic leukemia (CMML) |
Leucemia mieloide acuta (LMA), sindromi mielodisplastiche (MDS) e leucemia mielomonocitica cronica (CMML) |
|
E.1.1.1 | Medical condition in easily understood language |
Myeloid leukemia (AML), myelodysplastic syndromes (MDS), chronic myelomonocytic leukemia (CMML), or a type of cancer with solid tumors. |
Leucemia mieloide (AML), sindromi mielodisplastiche (MDS), leucemia mielomonocitica cronica (CMML), o un tipo di tumore con tumori solidi. |
|
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 | PT |
E.1.2 | Classification code | 10000880 |
E.1.2 | Term | Acute myeloid leukaemia |
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 | 21.1 |
E.1.2 | Level | PT |
E.1.2 | Classification code | 10028533 |
E.1.2 | Term | Myelodysplastic syndrome |
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 | 21.0 |
E.1.2 | Level | PT |
E.1.2 | Classification code | 10009018 |
E.1.2 | Term | Chronic myelomonocytic leukaemia |
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 | Yes |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
To provide ongoing treatment with guadecitabine for subjects who benefited from guadecitabine treatment in a previous Astex-sponsored clinical study and to obtain long-term safety information. |
Fornire un trattamento continuativo con guadecitabina a soggetti che abbiano tratto beneficio dal trattamento con guadecitabina in uno studio clinico precedente sponsorizzato da Astex e ottenere informazioni sulla sicurezza a lungo termine. |
|
E.2.2 | Secondary objectives of the trial |
To obtain long-term survival information on subjects who participated in a previous Astex-sponsored guadecitabine clinical study. |
Ottenere informazioni sulla sopravvivenza a lungo termine di soggetti che abbiano partecipato a uno studio clinico precedente di guadecitabina sponsorizzato da Astex. |
|
E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
Subjects must fulfill all of the following inclusion criteria:
1. Previous participation in an Astex-sponsored guadecitabine clinical trial (including but not limited to SGI-110-01, SGI-110-04, SGI-110-05, SGI-110-06, and SGI-110-07), in which the subject was treated with
guadecitabine and was still on active treatment with guadecitabine at the time of database close for the prior study.
2. Subject is considered to be benefitting from guadecitabine treatment in the opinion of the treating investigator.
3. Subject is able to understand and comply with the study procedures, understand the risks involved in the study, and provide written informed consent before any study-specific procedure.
4. Women of childbearing potential (according to recommendations of the Clinical Trial Facilitation Group[CTFG]; see protocol Section 5.2 for details) must not be pregnant or breastfeeding and must have a negative pregnancy test at screening. Women of childbearing potential and men with female partners of childbearing potential must agree to practice 2 highly effective contraceptive measures of birth control (as described in Section 5.2) and must agree not to become pregnant or father a child while receiving guadecitabine and for at
least 3 months after completing guadecitabine treatment. |
I soggetti devono soddisfare tutti i seguenti criteri di inclusione: 1. Precedente partecipazione a una sperimentazione clinica di guadecitabina sponsorizzata da Astex (tra cui, ma non limitatamente a, SGI-110-01, SGI-110-04, SGI-110-05, SGI-110-06 e SGI-110-07), in cui il soggetto sia stato trattato con guadecitabina e continui ad essere in trattamento attivo con guadecitabina al momento della chiusura della banca dati dello studio precedente. 2. Possibilità che il soggetto tragga beneficio dal trattamento con guadecitabina, a giudizio dello sperimentatore curante. 3. Capacità del soggetto di comprendere e conformarsi alle procedure dello studio, comprendere i rischi connessi allo studio e fornire il consenso informato prima dell’esecuzione di qualsiasi procedura specifica dello studio. 4. Le donne in età fertile (conformemente alle raccomandazioni del Clinical Trial Facilitation Group [CTFG]; per informazioni dettagliate, vedere il Paragrafo 5.2 del protocollo) non devono essere in gravidanza né in allattamento e devono risultare negative al test di gravidanza allo screening. Le donne in età fertile e gli uomini con partner di sesso femminile in età fertile devono accettare di adottare 2 metodi contraccettivi altamente efficaci (come descritto al Paragrafo 5.2) e devono acconsentire a non rimanere incinta e a non procreare mentre ricevono guadecitabina e per almeno 3 mesi dopo il completamento del trattamento con guadecitabina. |
|
E.4 | Principal exclusion criteria |
Subjects meeting any of the following exclusion criteria will be excluded from the study:
1. Any subject who, in the opinion of the investigator, may have other conditions, organ dysfunction, or have safety data from their prior study participation that suggest that the risks of continuing treatment with guadecitabine may outweigh the benefits
|
Saranno esclusi dallo studio i soggetti che soddisfano uno qualsiasi dei seguenti criteri di esclusione: 1. Qualsiasi soggetto che, a giudizio dello sperimentatore, possa presentare altre patologie, disfunzioni organiche o dati di sicurezza ottenuti dalla partecipazione a uno studio precedente che suggeriscano la possibilità che i rischi associati alla continuazione del trattamento con guadecitabina superino i benefici. |
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E.5 End points |
E.5.1 | Primary end point(s) |
Safety as measured by adverse events |
Sicurezza, come misurata sulla base degli eventi avversi. |
|
E.5.1.1 | Timepoint(s) of evaluation of this end point |
See the protocol |
fare riferimento al protocollo |
|
E.5.2 | Secondary end point(s) |
Survival status. |
Stato di sopravvivenza. |
|
E.5.2.1 | Timepoint(s) of evaluation of this end point |
See the protocol |
Fare riferimento al protocollo |
|
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) | 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 | 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) | 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
| 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 | 16 |
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 |
Canada |
Japan |
Korea, Republic of |
Taiwan |
United States |
Austria |
France |
Hungary |
Italy |
Spain |
|
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
|
The study may continue as long as subjects are receiving treatment with guadecitabine, or until guadecitabine becomes commercially available (anticipated for Q4 of 2019 at the earliest). |
Lo studio può continuare fino a quando i soggetti ricevono un trattamento con guadecitabina, o fino a quando la guadecitabina diventa commercialmente disponibile (anticipato per il quarto trimestre del 2019 al più presto). |
|
E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 1 |
E.8.9.1 | In the Member State concerned months | 6 |
E.8.9.1 | In the Member State concerned days | 0 |
E.8.9.2 | In all countries concerned by the trial years | 1 |
E.8.9.2 | In all countries concerned by the trial months | 6 |
E.8.9.2 | In all countries concerned by the trial days | 0 |