E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Solid tumors |
Tumores sólidos |
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E.1.1.1 | Medical condition in easily understood language |
Solid tumors |
Tumores sólidos |
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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 | 14.1 |
E.1.2 | Level | PT |
E.1.2 | Classification code | 10028997 |
E.1.2 | Term | Neoplasm malignant |
E.1.2 | System Organ Class | 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) |
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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 |
The purpose of this study is to assess the safety and tolerability of iniparib administered as monotherapy or in combination regimens in patients previously treated with iniparib in a clinical study and who have derived clinical benefit after completion of the parental study?s objectives. |
Evaluar la seguridad y tolerabilidad de iniparib administrado en monoterapia o en pautas combinadas en pacientes previamente tratados con iniparib en un estudio clínico y que han obtenido un beneficio clínico después de la finalización de los objetivos del estudio original. |
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E.2.2 | Secondary objectives of the trial |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
- Cancer patients greater than 18 years of age who have completed all assessments required to meet the primary objectives of a parental phase 1, 2 or 3 clinical study of iniparib as monotherapy or in a combination regimen. - Previously received and are continuing to derive clinical benefit from iniparib, as monotherapy or in combination with chemotherapy, as determined by the treating physician. - Ongoing treatment with iniparib at time of parental study completion/closure and meet criteria to initiate a subsequent cycle of therapy, as described in the parental study protocol. - On a stable parental study regimen (at least one cycle fo the regimen at the dose/schedule that isto be given in the Treatment Extension study must have been given prior to the patient's discontinuation from the parental study). - Signed written informed consent. |
I 01. Pacientes oncológicos mayores de 18 años de edad que han completado todas las evaluaciones necesarias para cumplir los objetivos principales del estudio original de fase I, II o III de iniparib en monoterapia o en una pauta combinada.
I 02. Pacientes que han recibido previamente y que continúan obteniendo un beneficio clínico de iniparib, en monoterapia o en combinación con quimioterapia, determinado por el médico encargado del tratamiento.
I 03. Tratamiento en curso con iniparib en el momento del cierre/finalización del estudio original y que cumplen los criterios para iniciar un ciclo de tratamiento, como se describe en el protocolo del estudio original.
I 04. En una pauta estable del estudio original (antes de la interrupción del estudio original debe haberse administrado al menos un ciclo a la dosis/pauta que se administrará en el estudio de extensión del tratamiento).
I 05. Consentimiento informado por escrito. |
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E.4 | Principal exclusion criteria |
- Patient has not previously participated in any clinical trial of iniparib. - Patient has evidence of progressive disease while receiving iniparib. - Patient has another concurrent invasive malignancy (aside from the malignancy for which the patient has received therapy for on the parental protocol). - Patient has a major medical or co-morbid condition(s) that the investigator believes might compromise safe participation in the study (such as uncontrolled lung, kidney, or liver problems; uncontrolled infection; a history of congestive heart failure; or an electrocardiogram suggesting significant problems with the heart). - Patient has not recovered to baseline or less than Grade 1 from non-hematologic adverse events related to any anticancer therapy received prior to signing informed consent on the Treatment Extension study, with the exception of hair loss. - Patient is receiving concurrent treatment with other investigational agents not allowed as part of the combination regimen in the parental study protocol. - Concurrent anticancer treatment with any agent other than iniparib and any co-administered chemotherapeutic agent(s) specificied on the parental study protocol are not permitted throughout the course of the study. - Patient is receiving concurrent radiation therapy to treat primary disease with curative intent. (Note that palliative radiotherapy is allowed as long as there is no evidence of progressive disease.) - Patient is unable to comply with the requirements of the study. - Pregnant or breast-feeding women. - Women of childbearing potential or men with partners of childbearing potential who are not protected or who are unwilling to use an effective contraceptive method of birth control during the course of the study and for a period of 6 months following the last dose. |
E 01. El paciente no ha participado previamente en otros ensayos clínicos con iniparib.
E 02. El paciente presenta indicios de enfermedad progresiva mientras recibe iniparib.
E 03. El paciente tiene otra neoplasia maligna invasiva concurrente (aparte de la neoplasia maligna para la cual el paciente ha recibido tratamiento conforme al protocolo original).
E 04. El paciente tiene una enfermedad médica grave o concomitante que el investigador cree que podría comprometer la seguridad de su participación en el estudio (es decir, insuficiencia pulmonar, renal o hepática no controlada; infección no controlada; antecedentes de insuficiencia cardíaca congestiva; o un ECG que indica un defecto importante de conducción o isquemia miocárdica).
E 05. El paciente no se ha recuperado a un grado basal o a un Grado ? 1 de AA no hematológicos (según NCI-CTCAE v4.03) relacionados con cualquier tratamiento antineoplásico antes de firmar el consentimiento informado para el estudio de extensión del tratamiento, con la excepción de alopecia.
E 06. El paciente está recibiendo actualmente tratamiento con otros fármacos en investigación no permitidos como parte de la pauta combinada del protocolo del estudio original.
E 07. Durante el estudio no está permitido el tratamiento antineoplásico concurrente con ningún fármaco distinto de iniparib ni ningún antineoplásico coadministrado especificado en el protocolo del estudio original.
E 08. El paciente está recibiendo radioterapia concurrente para tratar la enfermedad primaria con intención curativa. (Obsérvese que el tratamiento paliativo de radioterapia se permite siempre que no existan indicios de enfermedad progresiva).
E 09. El paciente es incapaz de cumplir los requisitos del estudio.
E 10. Mujer embarazada o en periodo de lactancia.
E 11. Las mujeres en edad fértil o varones con parejas en edad fértil que no utilicen anticonceptivos o que no estén dispuestos a utilizar un método anticonceptivo eficaz durante el transcurso del estudio y durante un período de 6 meses después de la última dosis. |
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E.5 End points |
E.5.1 | Primary end point(s) |
Number of participants with incidence of adverse events by NCI-CTCAE version 4.03 |
Número de partipantes con una incidencia de efectos adversos que se definirán por los criterios NCI-CTCAE versión 4.03. |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
During treatment and up to 30 days after last treatment dose |
Durante el tratamiento y hasta 30 días después de la última dosis |
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E.5.2 | Secondary end point(s) |
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
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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) | 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 | 75 |
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 |
Belgium |
Canada |
France |
Germany |
Hungary |
Israel |
Italy |
Luxembourg |
Netherlands |
Poland |
Romania |
Spain |
United Kingdom |
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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
|
Last Patient Last Visit |
Última visita del Último paciente |
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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 | 1 |
E.8.9.1 | In the Member State concerned months | 9 |
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 | 9 |
E.8.9.2 | In all countries concerned by the trial days | 0 |