E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
METASTATIC/RECURRENT/PERSISTENT UTERINE CERVICAL CARCINOMA |
Carcinoma della cervice uterina metastatico persistente o ricorrente |
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E.1.1.1 | Medical condition in easily understood language |
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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 | 20.0 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10046769 |
E.1.2 | Term | Uterine carcinoma |
E.1.2 | System Organ Class | 100000004864 |
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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 objective of this prospective clinical Phase II study is the evaluation of activity and safety of Niraparib in the salvage treatment of metastatic/persistent/recurrent uterine cervical cancer patients. |
L'obiettivo è la valutazione dell'attività ed efficacia di Niraparib in pazienti affette da carcinoma della cervice uterina metastatico persistente/ricorrente. |
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E.2.2 | Secondary objectives of the trial |
The secondary end-points are: treatment-related toxicity, assessment of quality of life, progression-free survival (PFS), defined as the time interval from the beginning of treatment to the documented radiologic progression or the date last seen, and overall survival (OS) defined as the time interval from the first drug administration to death or date last seen. |
Gli obiettivi secondari: tossicità legata al trattamento, valutazione della qualità di vita, intervallo libero da progressione (PFS), definite come l’intervallo dall’inizio del trattamento alla progressione radiologica di malattia, o all’ultima visita, e la sopravvivenza globale, definita come l’intervallo dalla prima somministrazione del trattamento alla morte o ultima visita della paziente. |
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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 |
Other types of substudies Specify title, date and version of each substudy with relative objectives: Evaluation of molecular markers associated with Niraparib response ver 1.6 09feb2018
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Altre tipologie di sottostudi specificare il titolo, la data e la versione di ogni sottostudio con i relativi obiettivi: Valutazione di markers molecolari associati al trattamento con Niraparib ver 1.6 09feb2018
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E.3 | Principal inclusion criteria |
Biopsy-proven diagnosis of cervical carcinoma was required, age >18 years and < 75 years, Eastern Cooperative Oncology Group (ECOG) performance status =2, presence of measurable disease, life expectancy >3 months, only 1 platinum based therapy (with or without bevacizumab) as first treatment of metastatic disease or recurrence or persistence of disease, absolute neutrophil count (ANC) >1,500/mm3; platelets count >100,000/ mm3; bilirubin and creatinine levels less than 1.5 times the upper limit of normal. |
Diagnosi istologica di carcinoma della cervice uterine, età >18 aa ed < 75 aa, Eastern Cooperative Oncology Group (ECOG) performance status =2, presenza di malattia misurabile, aspettativa di vita >3 months, solo un primo regime chemioterapico a base di platino per la malattia metastatica, ricorrente o persistente, neutrofili >1,500/mm3; piastrine >100,000/ mm3; bilirubina e livelli di creatinina < 1.5 ULN. |
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E.4 | Principal exclusion criteria |
Patients with recurrent disease were excluded if they were candidates for curative therapy by means of pelvic exenteration, previous or concomitant malignant disease (with the exception of cutaneous basalioma if adequately treated), active neurologic or psychiatric disease. |
Pazienti con malattia ricorrente che sono canditati a trattamento curativo attraverso eviscerazione pelvica, precedente o concomitante neoplasia (con l’eccezione di basalioma cutaneo se adeguatamente trattato), malattie neurologiche o psichatriche attive. |
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E.5 End points |
E.5.1 | Primary end point(s) |
Assessment of objective response rate (ORR). |
Valutazione del tasso di risposte obiettive (ORR). |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
8 weeks for the first 2 cycles and 12 weeks by the third cycle |
8 settimane per primi 2 cicli e 12 settimane dal 3° ciclo in poi |
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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 | No |
E.6.4 | Safety | No |
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 | 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 | No |
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 | Information not present in EudraCT |
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 | 1 |
E.8.9.1 | In the Member State concerned months | 4 |
E.8.9.1 | In the Member State concerned days | 1 |
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 | 4 |
E.8.9.2 | In all countries concerned by the trial days | 1 |