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 aguda (AML), síndromes mielodisplásicos(MDS), y
leucemia mielomonocítica crónica (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), síndromes mielodisplásicos(MDS), leucemia
mielomonocítica crónica (CMML), o un tipo de cáncer de los tumores
sólidos. |
|
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 | 20.0 |
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 | 20.0 |
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 | 20.0 |
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. |
Proporcionar tratamiento continuado con guadecitabina a pacientes que
se beneficiaron del tratamiento de guadecitabina en un estudio clínico
previo promovido por Astex, y obtener información de la seguridad a
largo plazo. |
|
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. |
Obtener información de la supervivencia a largo plazo en pacientes que
participaron en un estudio clínico previo de guadecitabina promovido por
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. |
Los pacientes deben cumplir todos los criterios de inclusión siguientes:
1.Participación previa en un ensayo clínico de guadecitabina promovido
por Astex (entre otros, SGI 110 01, SGI 110-04, SGI 110 05, SGI-110-06
y SGI-110-07), en el cual el paciente fue tratado con guadecitabina y
seguía recibiendo dicho tratamiento activo en el momento del cierre de
la base de datos para el estudio anterior.
2.En opinión del investigador responsable del tratamiento, el paciente
sigue beneficiándose del tratamiento con guadecitabina.
3.El paciente es capaz de entender y cumplir con los procedimientos del
estudio, comprende los riesgos que implica el estudio y proporciona el
consentimiento informado por escrito antes de llevar a cabo ningún
procedimiento específico del estudio.
4.Las mujeres con capacidad de concebir (de acuerdo con las
recomendaciones del Grupo de facilitación del ensayo clínico [Clinical
Trial Facilitation Group, CTFG]; para más información, véase la sección
5.2 del protocolo) no deben estar embarazadas ni amamantando y deben
presentar un resultado negativo en la prueba de embarazo en la
selección. Las mujeres con capacidad de concebir y los hombres con
parejas que tengan capacidad de concebir deben aceptar el uso de 2
métodos anticonceptivos altamente eficaces (tal como se describe en la
sección 5.2) y deben aceptar no quedarse embarazadas o engendrar un
hijo mientras estén recibiendo guadecitabina y durante un mínimo de 3
meses tras finalizar el tratamiento 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 |
Los pacientes que cumplan alguno de los criterios de exclusión
siguientes no podrán participar en el estudio:
1.Cualquier paciente que, en opinión del investigador, pueda tener otra
enfermedad o disfunción orgánica o tener datos de seguridad de la
participación en el estudio anterior que sugieran que los riesgos de
continuar el tratamiento con guadecitabina podrían superar a los
beneficios. |
|
E.5 End points |
E.5.1 | Primary end point(s) |
Safety as measured by adverse events |
Seguridad determinada mediante los acontecimientos adversos. |
|
E.5.1.1 | Timepoint(s) of evaluation of this end point |
For the primary endpoint of safety as assessed by adverse events, this process is ongoing, and rather than occurring at specific pre-specified timepoints. Practically, the SGI-110 program is reviewed at least quarterly for any changes in safety profile, but based on new events reported may be reviewed at any time. Summary safety tables specific to Study SGI-110-12 would be completed after the last patient has discontinued treatment and been withdrawn from the study. |
Con respecto al criterio de valoración principal de la seguridad evaluado mediante los acontecimientos adversos, este proceso es continuo y no se produce en puntos temporales previamente especificados. En la práctica, el programa SGI-110 se revisa al menos trimestralmente para detectar cualquier cambio en el perfil de seguridad, pero en función de los nuevos acontecimientos notificados se puede revisar en cualquier momento. Las tablas resumen de seguridad específicas para el estudio SGI-110-12 se completarán después de que el último paciente haya interrumpido el tratamiento y se haya retirado del estudio. |
|
E.5.2 | Secondary end point(s) |
Survival status. |
Estado de supervivencia |
|
E.5.2.1 | Timepoint(s) of evaluation of this end point |
For the secondary endpoint of survival, there are no planned interim analyses planned and survival data would be summarized after the last subject has discontinued treatment and been withdrawn from the study. |
En el caso del criterio de valoración secundario de la supervivencia, no se han programado análisis provisionales y los datos de supervivencia se resumirán después de que el último sujeto haya interrumpido el tratamiento y se haya retirado del estudio. |
|
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 | 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 | No |
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 | 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 | 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 |
Austria |
Canada |
Denmark |
France |
Hungary |
Italy |
Japan |
Korea, Republic of |
Poland |
Spain |
Taiwan |
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
|
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). |
El estudio puede continuar mientras los sujetos estén recibiendo tratamiento con guadecitabina, o hasta que guadecitabina esté
disponible comercialmente (anticipado para el cuarto trimestre de 2019 como pronto). |
|
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 |