E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Solid Tumors |
Tumori solidi |
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E.1.1.1 | Medical condition in easily understood language |
Tumori solidi |
Tumori solidi |
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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 |
Valutare la sicurezza e la tollerabilità di iniparib somministrato in monoterapia o in regimi di associazione in pazienti trattati con iniparib in un precedente studio clinico che hanno ottenuto un beneficio clinico in seguito al completamento degli obiettivi dello studio originario. |
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E.2.2 | Secondary objectives of the trial |
not applicabile |
non applicabile |
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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. Pazienti affetti da tumore di almeno 18 anni di età che hanno completato tutte le valutazioni necessarie per soddisfare gli obiettivi primari di uno studio clinico originario di fase 1, 2 o 3 su iniparib in monoterapia o in regime di associazione. I 02. Pazienti precedentemente trattati con iniparib che continuano a trarre un beneficio clinico da iniparib, in monoterapia o in associazione a chemioterapia, in base a quanto stabilito dal medico sperimentatore. I 03. Pazienti in trattamento con iniparib al momento del completamento o della conclusione dello studio originario che soddisfano i criteri per iniziare un successivo ciclo di terapia, come descritto nel protocollo dello studio originario. I 04. Pazienti in regime stabile rispetto allo studio originario (almeno un ciclo del regime terapeutico alla dose/dosaggio che si intende somministrare nello studio di estensione della terapia deve essere stato somministrato al paziente prima che questo concludesse la sua partecipazione allo studio originario). I 05. Consenso informato scritto firmato |
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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. Pazienti che non abbiano partecipato a precedenti studi clinici su iniparib. E 02. Pazienti che presentino una progressione della malattia durante il trattamento con iniparib. E 03. Pazienti affetti da un altro tumore maligno invasivo concomitante (ad eccezione del tumore maligno per cui il paziente ha ricevuto il trattamento nel protocollo originario). E 04. Pazienti che presentino patologie gravi o condizioni di comorbidità che, in base all’opinione dello sperimentatore, possono compromettere la sicurezza della partecipazione allo studio (ossia disfunzione epatica, renale o polmonare non controllata, infezione non controllata, anamnesi di insufficienza cardiaca congestizia o un ECG che suggerisce la presenza di un difetto di conduzione significativo o di ischemia miocardica). E 05. Pazienti che non si siano ristabiliti da AE non ematologici rispetto al basale o di grado ≤ 1 (secondo i criteri NCI-CTCAE, versione 4.03) correlati alla terapia antitumorale ricevuta prima della firma del consenso informato relativo allo studio di estensione del trattamento, ad eccezione dell’alopecia. E 06. Pazienti attualmente in trattamento con altri agenti sperimentali non consentiti come parte del regime di associazione nel protocollo dello studio originario. E 07. Nel corso dello studio, non è consentita alcuna terapia antitumorale concomitante con farmaci sperimentali diversi da iniparib e dagli agenti chemioterapici somministrati congiuntamente a iniparib come specificato nel protocollo dello studio originario. E 08. Pazienti che stanno seguendo un trattamento radioterapico concomitante per trattare la malattia di base con intento curativo (si noti che la radioterapia palliativa è consentita finché non vi sia evidenza di progressione della malattia). E 09. Pazienti che non siano in grado di rispettare i requisiti dello studio. E 10. Donne in stato di gravidanza o che allattano al seno. E 11. Donne in età fertile o uomini con partner in età fertile che hanno rapporti non protetti o che non intendono utilizzare un metodo contraccettivo efficace nel corso dello studio e per un periodo di 6 mesi dalla somministrazione dell’ultima dose. |
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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 |
L’endpoint primario di questo studio è la valutazione della sicurezza e della tollerabilità di iniparib. La sicurezza sarà valutata in base all’incidenza e alla frequenza degli eventi avversi /criteri NCI-CTCAE (versione 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 il trattamento e fino a 30 giorni dopo l'ultima somministrazione |
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E.5.2 | Secondary end point(s) |
not applicable |
non applicabile |
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
not applicable |
non applicabile |
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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 | 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) | Information not present in EudraCT |
E.8.2.2 | Placebo | Information not present in EudraCT |
E.8.2.3 | Other | Information not present in EudraCT |
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 | 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 | No |
E.8.6.2 | Trial being conducted completely outside of the EEA | No |
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
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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 | 0 |
E.8.9.1 | In the Member State concerned months | 21 |
E.8.9.1 | In the Member State concerned days | 0 |
E.8.9.2 | In all countries concerned by the trial years | 0 |
E.8.9.2 | In all countries concerned by the trial months | 21 |
E.8.9.2 | In all countries concerned by the trial days | 0 |