E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
solid tumors |
tumores sólidos |
|
E.1.1.1 | Medical condition in easily understood language |
solid tumors |
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 | 21.0 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10049280 |
E.1.2 | Term | Solid tumour |
E.1.2 | System Organ Class | 100000004864 |
|
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 | 10065143 |
E.1.2 | Term | Malignant solid tumour |
E.1.2 | System Organ Class | 100000004864 |
|
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 | 10065147 |
E.1.2 | Term | Malignant solid tumor |
E.1.2 | System Organ Class | 100000004864 |
|
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 |
|
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 the safety and tolerability of study intervention(s) |
Supervisar la seguridad y tolerabilidad del (de las) intervención(es) del estudio |
|
E.2.2 | Secondary objectives of the trial |
|
E.2.3 | Trial contains a sub-study | Yes |
E.2.3.1 | Full title, date and version of each sub-study and their related objectives |
AN OPEN-LABEL STUDY FOR CONTINUED TREATMENT ACCESS FOR PARTICIPANTS FROM THE C4221009 (ARRAY-818-302, BEACON) AND W00090 GE 2 01 (ANCHOR CRC) ENCORAFENIB BINIMETINIB AND CETUXIMAB STUDIES
OR
AN OPEN-LABEL STUDY FOR CONTINUED TREATMENT ACCESS FOR PARTICIPANTS FROM THE C4221009 (ARRAY-818-302, BEACON) AND W00090 GE 2 01 (ANCHOR CRC) ENCORAFENIB BINIMETINIB AND CETUXIMAB STUDIES |
ESTUDIO ABIERTO PARA EL ACCESO CONTINUADO AL TRATAMIENTO DE PARTICIPANTES DE LOS ESTUDIOS SOBRE ENCORAFENIB BINIMETINIB Y CETUXIMAB C4221009 (ARRAY-818-302, BEACON) Y W00090 GE 2 01 (ANCHOR CRC)
O
UN ESTUDIO ABIERTO PARA EL ACCESO CONTINUADO AL TRATAMIENTO PARA PARTICIPANTES DE LOS ESTUDIOS C4221003 (ARRAY-818-103), C4221006 (ARRAY-818- 201) Y C4221013 (ARRAY CLGX818X2109) DE ENCORAFENIB Y BINIMETINIB |
|
E.3 | Principal inclusion criteria |
1. Any participant who is receiving study intervention and deriving clinical benefit (as determined by the principal investigator) in an encorafenib/binimetinib Parent Study, with no ongoing NCI CTCAE version 4.03 Grade ≥3 or intolerable Grade 2 AEs considered to be related to study treatment.
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) of the applicable Encorafenib/Binimetinib Continuation Sub-Study Protocol.
3.Participants who are willing and able to comply with all scheduled visits, treatment plan, and other study procedures as outlined in the appliable Encorafenib/Binimetinib Continuation Sub-Study Protocol.
4.Capable of giving signed informed consent as described in Appendix 1, Section 10.1.3, which includes compliance with the requirements and restrictions listed in the ICD and in this protocol |
1. Cualquier participante que esté recibiendo la intervención del estudio y obtenga beneficio clínico (según lo determine el investigador principal) en un estudio principal de encorafenib/binimetinib, sin AA de grado ≥3 en curso según los CTCAE del NCI o de grado 2 intolerable que se consideren relacionados con el tratamiento del estudio.
2. Los participantes deben estar de acuerdo en seguir los criterios reproductivos descritos en el apéndice 4 (sección 10.4.1 para los hombres y sección 10.4.2 para las mujeres) del protocolo del subestudio de continuación de encorafenib/binimetinib aplicable.
3. Los participantes deben estar dispuestos y ser capaces de cumplir con todas las visitas programadas, el plan de tratamiento y otros procedimientos del estudio, tal y como se describen en el protocolo del subestudio de continuación de encorafenib/binimetinib aplicable.
4. Deben ser capaces de otorgar el consentimiento informado firmado, tal y como se describe en el apéndice 1, sección 10.1.3, lo que comprende el cumplimiento de los requisitos y las restricciones indicados en el documento de consentimiento informado (FCI) y en este protocolo. |
|
E.4 | Principal exclusion criteria |
Participants are excluded from the study if the following criteria apply: 1. Any medical reason that, in the opinion of the investigator or sponsor, precludes the participant from inclusion in the study |
Los participantes serán excluidos del estudio si cumplen los criterios siguientes: 1. Cualquier motivo médico que, en opinión del investigador o del promotor, impida al participante la inclusión en el estudio. |
|
E.5 End points |
E.5.1 | Primary end point(s) |
- AEs leading to permanent discontinuation of study intervention - All SAEs |
- AA que provoquen la interrupción permanente del tratamiento del estudioa - Todos los acontecimientos adversos graves (AAG) |
|
E.5.1.1 | Timepoint(s) of evaluation of this end point |
throughout the study |
a lo lago del estudio |
|
E.5.2 | Secondary end point(s) |
|
E.5.2.1 | Timepoint(s) of evaluation of this end point |
|
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 | No |
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 | Yes |
E.6.13.1 | Other scope of the trial description |
tolerability |
tolerabilidad |
|
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 | 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 | Yes |
E.8.1.7.1 | Other trial design description |
ESTUDIO DE CONTINUACIÓN PARA PARTICIPANTES QUE CONTINÚEN DESDE ENSAYOS CLÍNICOS DE ENCORAFENIB/BI |
CONTINUATION STUDY FOR PARTICIPANTS CONTINUING FROM ENCORAFENIB/BINIMETINIB CLINICAL STUDIES |
|
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 | 3 |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.5.1 | Number of sites anticipated in the EEA | 13 |
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 |
Japan |
United States |
France |
Netherlands |
Spain |
Switzerland |
Italy |
Belgium |
Norway |
United Kingdom |
|
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 end of this master protocol is defined as when the last participant in the last Encorafenib/Binimetinib Continuation Sub-Study has discontinued from the study, or 5 years after the first dose for the last participant of each Encorafenib/Binimetinib Continuation SubStudy (whichever is sooner). However, the sponsor may terminate the Master Continuation Protocol for Encorafenib/Binimetinib or any of its Sub-Studies at any time. |
El final de protocolo maestro se define como el último paciente que haya discontinuado en el último sub-estudio de continuación de encorafenib/binimetinib, o tras 5 años desde la primera dosis del último paciente de cada sub-estudio de continuación de encorafenib/binimetinib (lo que ocurra antes). Sin embargo, el promotor, puede terminar el protocolo maestro de continuación para encorafenib/binimetinib o cualquiera de sus sub-estudios en cualquier momento. |
|
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 | 5 |
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 |