Phase II, single arm, multicenter, open-label study of PARP inhibitors + cisplatin in Recurrent and/or Metastatic Adenoid Cystic Carcinoma

Phase 1

• Conditions: patients with recurrent and/or Metastatic Adenoid Cystic Carcinoma; MedDRA version: 21.0Level: PTClassification code 10053231Term: Adenoid cystic carcinomaSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps); MedDRA version: 21.0Level: PTClassification code 10073370Term: Adenoid cystic carcinoma of salivary glandSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps); MedDRA version: 24.1Level: LLTClassification code 10085951Term: Adenoid cystic carcinoma metastaticSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps); Therapeutic area: Diseases [C] - Cancer [C04]

• Registration Number: EUCTR2022-004188-25-IT
• Lead Sponsor: AZIENDA SOCIO SANITARIA TERRITORIALE DEGLI SPEDALI CIVILI DI BRESCIA

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2023-01-10
• Last Update Posted: 11 September 2023

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 27

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

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.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: evaluate activity of the PARPi niraparib in combination with cisplatin;Secondary Objective: Overall Survival assessed according to RECIST 1.1<br>Progression Free Survival assessed according to RECIST 1.1<br>Safety assessed according to CTCAE 5.0<br>QoL assessed by QoL QLQ HN43 and C30 questionnairecurativo standard. Diagnosi di recidiva a meno di 6 mesi dall’inizio del trattamento sperimentale previsto;<br>- 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;<br>- 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 Outcome Measures

Name	Time	Method
Secondary end point(s): Overall Survival assessed according to RECIST 1.1<br>Progression Free Survival assessed according to RECIST 1.1<br>Safety assessed according to CTCAE 5.0<br>QoL assessed by QoL QLQ HN43 and C30 questionnaire;Timepoint(s) of evaluation of this end point: every time to followup