patients with recurrent and/or Metastatic Adenoid Cystic Carcinoma MedDRA version: 21.0 Level: PT Classification code 10053231 Term: Adenoid cystic carcinoma System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA version: 21.0 Level: PT Classification code 10073370 Term: Adenoid cystic carcinoma of salivary gland System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA version: 21.0 Level: PT
Conditions
Interventions
Product Name: cisplatino
Product Code: [cisplatino]
Pharmaceutical Form: Concentrate for solution for injection/infusion
INN or Proposed INN: CISPLATINO
Current Sponsor code: cisplatino
Concentration
Sponsors
AZIENDA SOCIO SANITARIA TERRITORIALE DEGLI SPEDALI CIVILI DI BRESCIA
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Age = 18 years; - Signature Informed Consent; - Histological diagnosis of ACC;Primary ACC not amenable of curative standard of care treatments (i.e., unresectable tumors, and/or lesions impossible to irradiate for any reason); - Locoregional recurrent ACC not amenable to curative standard of care treatments (i.e., unresectable tumors, and/or lesions impossible to re-irradiate for any reason) with a history of clinical or symptomatic disease progression within 6 months; - Metastatic ACC (distant spread) not amenable to surgical therapy or radiotherapy and with a history of clinical or symptomatic disease progression within 6 months; - Prior treatment with targeted therapy and/or chemotherapy is allowed if performed more than 4 weeks since protocol start: - ECOG PS of 0-1; - Adequate hematologic and organ functions Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 20 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 7
Exclusion criteria
Exclusion criteria: History of severe allergic or anaphylactic reactions or hypersensitivity to recombinant proteins or excipients in the investigational agent; Previous treatment with PARPi; Uncontrolled central nervous system (CNS) metastases, including leptomeningeal metastases; Failure to recover to grade 1 or baseline from all toxic effects of previous chemotherapy, radiation therapy, biologic therapy, immunotherapy, and/or experimental therapy; Medical conditions that might interfere with study treatment; Women must not be pregnant or breastfeeding; pregnant women are excluded from this study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: evaluate activity of the PARPi niraparib in combination with cisplatin;Secondary Objective: Overall Survival assessed according to RECIST 1.1 Progression Free Survival assessed according to RECIST 1.1 Safety assessed according to CTCAE 5.0 QoL assessed by QoL QLQ HN43 and C30 questionnairecurativo standard. Diagnosi di recidiva a meno di 6 mesi dall’inizio del trattamento sperimentale previsto; - Recidiva a distanza o ACC metastatico ab initio non candidabile a trattamento curativo standard. Diagnosi di recidiva a distanza a meno di 6 mesi dall’inizio del trattamento sperimentale previsto; - Pregresso trattamento con terapia target e/o chemioterapia è permesso se effettuato almeno 4 settimane prima dell'avvio del trattamento sperimentale previsto;;Primary end point(s): Overall Response Rate (ORR) assessed according to RECIST 1.1;Timepoint(s) of evaluation of this end point: every time to followup | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Overall Survival assessed according to RECIST 1.1 Progression Free Survival assessed according to RECIST 1.1 Safety assessed according to CTCAE 5.0 QoL assessed by QoL QLQ HN43 and C30 questionnaire;Timepoint(s) of evaluation of this end point: every time to followup | — |
Countries
Italy
Contacts
Public ContactPROGETTAZIONE RICERCA E STUDI DI F1
ASST DEGLI SPEDALI CIVILI DI BRESCIA
Outcome results
None listed