Niraparib Efficacy in patients with unResectable MesotheliOma: A randomised phase II trial of Niraparib versus active symptom control in patients with previously treated mesothelioma
Personalised therapy for mesothelioma is lacking. Based on published single agent activity, inhibition of Poly-ADP ribose polymerase is a promising treatment strategy warranting further study. Accordingly, NERO is a randomised phase II study designed to evaluate the efficacy of PARP inhibition in mesothelioma.
Mesothelioma patients with any histological subtype (epithelioid or non-epithelioid) and any site (pleural or peritoneal) who have previously received approved systemic therapy containing platinum will be randomised between Active Symptom Control (ASC)+Niraparib and ASC. Patients will be randomised in a 2:1 ratio to the Niraparib arm. Randomisation will be stratified by histology and best response to platinum therapy. NERO aims to recruit 84 patients (56 in the intervention arm and 28 in the control arm) from approximately 10 UK sites.
Primary:
Secondary:
To determine whether Niraparib (over ASC)
Translational:
A multicentre, two arm, open-label UK randomised phase II trial in patients with mesothelioma of any histological subtype and any site who have previously received an approved systemic therapy containing platinum.
Closed to recruitment / In follow-up
Mesothelioma patients with any histological subtype (epithelioid or non-epithelioid) and any site (pleural or peritoneal mesothelioma) who have previously received an approved systemic therapy containing pemetrexed-platinum. NERO is not restricted by line of therapy.
This trial is funded by Asthma and Lung UK, with additional support from Cancer Research UK
Senior Trial Manager:
Zina Eminton
Trial Manager:
Daniel Griffiths
Trial Coordinator:
Abigail Morgan-Fox
Data Manager:
Zoe Konn
Clinical Data Coordinator:
Katie Mansell
Email: NERO@soton.ac.uk
Phone: 023 8120 5154
Email: ctu@soton.ac.uk
NERO - Protocol v7 13-Sep-2023
NERO - Site Training Log Template, v1.0 16-May-2022
NERO - Patient Drug Diary v1.0 09-Mar-2022
NERO - Site Delegation Log v1.0 16-May-2022
NERO - Pregnancy Consent Form V1.0 31-May-22
NERO - Pregnancy IS V1.0 31-May-22
NERO - Investigator Site File Index, v1 18-May-2022
NERO - Site Training Log Template, v1 16-May-2022
NERO - iMedidata Contact Sheet, v1 16-May-2022
NERO - Site Visit Log, v1 16-May-2022
NERO - Master Patient List, v1 16-May-2022
NERO - eCRF Completion Guidance, v2 16-Mar-2023
NERO - Laboratory manual v4 16-Aug-2023
NERO - Blood Storage and Shipment Logs, v1 16-May-2022
NERO - Tissue Tracking Log Samples sent by site to Central Lab, v1 16-May-2022
NERO - Pharmacy Manual v1.0 09-Mar-2022
NERO - PRANCER user manual_TESARO IST Program - Site User Manual v1.0.
NERO Niraparib Destruction Log V1 16-May-2022
NERO Niraparib Returns Log V1 16-May-2022
NERO - MDS - Site-Based Depot and In-Transit from Local Depot Temperature Excursion Form - V28_final
NERO - Instructions for Adverse and Serious Adverse Event Reporting V1 16-May-2022
NERO - Serious Adverse Event V2 25-Jan-2023
NERO - SAE - SUSAR Follow-up Form V1 16-May-2022
NERO - IB - V 15 GSK3985771 Niraparib Tosylate Monohydrate en
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