E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
chronic lymphocytic leukemia/small lymphocytic lymphoma, mantle cell lymphoma, follicular lymphoma, and diffuse large B-cell lymphoma |
Leucemia linfocítica crónica / linfoma linfocítico de células pequeñas, linfoma de células del manto, linfoma folicular y linfoma difuso de célula grande B. |
|
E.1.1.1 | Medical condition in easily understood language |
chronic lymphocytic leukemia/small lymphocytic lymphoma, mantle cell lymphoma, follicular lymphoma, and diffuse large B-cell lymphoma |
Leucemia linfocítica crónica / linfoma linfocítico de células pequeñas, linfoma de células del manto, linfoma folicular y linfoma difuso de célula grande B. |
|
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 | 17.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10008976 |
E.1.2 | Term | Chronic lymphocytic leukemia |
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 | 18.0 |
E.1.2 | Level | PT |
E.1.2 | Classification code | 10061275 |
E.1.2 | Term | Mantle cell lymphoma |
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 | 18.0 |
E.1.2 | Level | HLT |
E.1.2 | Classification code | 10012819 |
E.1.2 | Term | Diffuse large B-cell lymphomas |
E.1.2 | System Organ Class | 100000004851 |
|
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 17.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10067070 |
E.1.2 | Term | Follicular B-cell non-Hodgkin's lymphoma |
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 |
The objective of this study is to collect long-term safety and efficacy data for subjects treated with PCI-32765 and to provide ongoing access to PCI-32765 for subjects who are currently enrolled in PCI-32765 studies that have been completed according to the parent protocol (eg, final analysis has been performed), are actively receiving treatment with PCI-32765, and who continue to benefit from PCI-32765 treatment. |
El objetivo de este ensayo es recoger datos de seguridad y eficacia a largo plazo en pacientes tratados con PCI-32765 y dar acceso de forma continuada al tratamiento con PCI-32765 a pacientes que están actualmente incluidos en ensayos con PCI-32765 que ya han sido completados de acuerdo al protocolo (ej. Análisis final realizado), que están recibiendo tratamiento con PCI-32765 de forma activa, y que continúan beneficiándose del tratamiento con PCI-32765. |
|
E.2.2 | Secondary objectives of the trial |
|
E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
- Participants must be currently participating in a PCI-32765 clinical study considered completed and have received at least 6 months of treatment with PCI-32765.
- At study entry, participants must be actively receiving treatment with single-agent PCI-32765
- Agrees to protocol-defined use of effective contraception
- Negative blood or urine pregnancy test at screening |
- Los sujetos participantes deben estar actualmente participando en un ensayo clínico con PCI-32765 que se considere completado y deben haber recibido al menos 6 meses de tratamiento con PCI-32765.
- Al entrar en el estudio, los participantes deben estar recibiendo tratamiento en monoterapia con PCI-32765 de forma activa.
- Deben estar de acuerdo en usar métodos anticonceptivos efectivos como los define el protocolo
- Deben tener un test de embarazo negativo en sangre u orina durante la selección. |
|
E.4 | Principal exclusion criteria |
- Requires anticoagulation with warfarin or equivalent vitamin K antagonists
- Requires treatment with strong cytochrome P450 (CYP)3A4/5 inhibitors, unless previously approved by sponsor
- Any condition or situation which, in the opinion of the investigator, may put the participant at significant risk, may confound the study results, or may interfere significantly with volunteer?s participation in the study |
- Requerir anticoagulación con warfarina o antagonistas de vitamina K equivalentes.
- Requerir tratamiento con inhibidores potentes del citocromo P450 (CYP) 3A4/5, salvo que hayan sido previamente aprobados por el promotor.
- Cualquier condición o situación, que en opinión del investigador, pueda poner al participante en un riesgo significativo, pueda afectar los resultados del estudio, o pueda interferir significativamente con la participación en el ensayo del voluntario. |
|
E.5 End points |
E.5.1 | Primary end point(s) |
Number of participants affected by an adverse event |
Número de participantes afectados por un acontecimiento adverso. |
|
E.5.1.1 | Timepoint(s) of evaluation of this end point |
Time frame = Up to 30 days after the last dose of study medication |
Plazo = Hasta 30 días después de la última dosis de la medicación del estudio. |
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E.5.2 | Secondary end point(s) |
Number of participants with change in disease status |
Número de participantes con cambios en el estado de la enfermedad |
|
E.5.2.1 | Timepoint(s) of evaluation of this end point |
Time frame = Up to the end-of-treatment visit (up to 30 days after the last dose of study medication) |
Plazo = Hasta la visita de fin de tratamiento (hasta 30 días después de la última dosis de la medicación 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 | 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 | Yes |
E.6.13.1 | Other scope of the trial description |
Biomarker evaluations |
Evaluaciones de biomarcadores |
|
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 | 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.8.2.4 | Number of treatment arms in the trial | 1 |
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 | 8 |
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 |
Australia |
Canada |
China |
Germany |
Israel |
Malaysia |
Poland |
Russian Federation |
Spain |
Taiwan |
United Kingdom |
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
|
3 years after first patient enrolled. |
3 años después del primer paciente incluido |
|
E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 3 |
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 | 3 |
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 |