E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Cisplatin-resistant germ cell cancer of the testicle or extragonadal GCC originating from retroperitoneum or mediastinum. |
Carcinoma germinale metastatico del testicolo o d'origine extragonadica, retroperitoneale o mediastinica, resistente al cisplatino. |
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E.1.1.1 | Medical condition in easily understood language |
cisplatin-resistant germ cell cancer of the testicle or extragonadal GCC originating from retroperitoneum or mediastinum. |
Carcinoma germinale metastatico del testicolo o d'origine extragonadica, retroperitoneale o mediastinica, resistente al cisplatino. |
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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 | 17.0 |
E.1.2 | Level | PT |
E.1.2 | Classification code | 10055103 |
E.1.2 | Term | Testicular cancer metastatic |
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 |
To evaluate the efficacy of cabazitaxel as monotherapy for the treatment of germ cell cancer. Efficacy is defined as objective responses according to RECIST 1.1. |
Valutare l’efficacia del cabazitaxel come monoterapia nel trattamento del cancro a cellule germinali. L’efficacia è definita come tasso di risposta obiettiva (ORR=objective response rate) secondo i criteri RECIST 1.1. |
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E.2.2 | Secondary objectives of the trial |
Disease control rate (SD + PR + CR); Progression-free survival; Overall survival; Safety profile; Change of serum tumor markers. |
Tasso di controllo di malattia (SD + PR + CR); Sopravvivenza libera da progressione (PFS); Sopravvivenza globale (OS); Profilo di sicurezza; Modifiche a livello dei marker tumorali sierici. |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
-Male patients ≥ 18 years old -Histologically verified metastatic GCC (germ cell cancer of the testicle or extragonadal GCC originating from retroperitoneum or mediastinum) -Disease progression during cisplatin-based chemotherapy or Disease progression or relapse after high-dose chemotherapy or Disease progression or relapse after at least 2 different platin-based regimens -ECOG Performance Status (PS): 0-2 -Signed written informed consent |
-Pazienti di sesso maschile con età ≥ 18 anni. -Diagnosi istologicamente confermata di carcinoma testicolare metastatico a cellule germinali o cancro a cellule germinali extragonadico con origine retro peritoneale o mediastinica. -Progressione durante chemioterapia a base di cisplatino o progressione/ricaduta dopo chemioterapia ad alte dosi o dopo almeno due regimi differenti a base di cisplatino. -ECOG Performance Status (PS): 0-2. -Firma del Consenso Informato.
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E.4 | Principal exclusion criteria |
-Systemic antitumor treatment within 21 days before study entry -Simultaneous radiotherapy to the only target lesion -Patients with unstable angina pectoris, myocardial infarction ≤ 6 months prior to first study treatment, congestive heart failure NYHA III-IV or serious uncontrolled cardiac arrhythmias -Patients with an active or uncontrolled infection -Patients who have a history of another primary malignancy and are off treatment for ≤ 3 years, with the exception of non-melanoma skin cancer -Active infection requiring systemic antibiotic-, anti-viral-, or antifungal medication -Neuropathy ≥ Grade 2 |
-Trattamento sistemico antitumorale nei 21 giorni precedenti l’entrata nello studio. -Radioterapia simultanea sulla stessa lesione target. -Pazienti con angina pectoris instabile, infarto del miocardio nei 6 mesi precedenti l’inizio dello studio, insufficienza congestiva NYHA III-IV o gravi aritmie cardiache non controllate. -Pazienti con infezione attiva o non controllata. -Pazienti che hanno avuto un altro tumore primario maligno e sono fuori trattamento da meno di 3 anni, con l’eccezione del cancro della pelle non-melanoma. -Infezione attiva che richiede l’utilizzo di terapie sistemiche antibiotiche, antivirali o antifungine. -Neutropenia di grado 2 CTC. |
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E.5 End points |
E.5.1 | Primary end point(s) |
Objective response rate (ORR) |
Tasso di risposta obiettiva (ORR=objective response rate) |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
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E.5.2 | Secondary end point(s) |
Safety profile /Adverse Events (AE);Disease control rate (SD + PR + CR); Progression-free survival (PFS) - time from inclusion to the date of disease progression or death from any cause;Overall survival (OS) - time from inclusion to the date of death from any cause;Change of serum tumormarkers (AFP, beta-betaHCG, LDH). |
Profilo di sicurezza/ Eventi Avversi, Tasso di controllo di malattia (SD + PR + CR), Sopravvivenza libera da progressione (PFS), Sopravvivenza globale (OS), Modifiche a livello dei marker tumorali sierici (AFP, beta-betaHCG, LDH). |
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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 | 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.8.5 | 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 |
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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
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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 | 3 |
E.8.9.1 | In the Member State concerned months | 7 |
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 | 7 |
E.8.9.2 | In all countries concerned by the trial days | 0 |