Multi-Centre Observational Study of Maintenance Niraparib in Treatment of Ovarian CanceR (MONITOR-UK)

January 5, 2022 updated by: Royal Marsden NHS Foundation Trust

Multi-Centre Observational Study of Maintenance Niraparib in Treatment of Ovarian CanceR: UK Routine Clinical Practice Experience

This is a multi-centre, observational (non-interventional) study, designed to follow patients with advanced ovarian fallopian tube and primary peritoneal cancer, who are receiving Niraparib as maintenance treatment, according to the Niraparib access criteria (via TESARO patient access programme, EMA licence and NHS pending NICE assessment due 2018) including assessment of tolerability to Niraparib therapy.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

This is a multi-centre, observational (non-interventional) study, designed to follow patients with advanced ovarian fallopian tube and primary peritoneal cancer, who are receiving Niraparib as maintenance treatment, according to the Niraparib access criteria (via TESARO patient access programme, EMA licence and NHS pending NICE assessment due 2018) including assessment of tolerability to Niraparib therapy. These pathways will include patients who have been registered and not prescribed drug. In these cases, the reason for patients not receiving Niraparib will be recorded. Up to 16 centres will be involved in the study. Centres will be selected based on interest in or experience of prescribing Niraparib and geographical location in order to give a representative picture of the management of Niraparib in the UK.

Cohort 1: Retrospective Cohort

This cohort will include:

  • Patients who have previously commenced maintenance Niraparib prior to the MONITOR study opening at the site and are still receiving Niraparib but in whom quality of life data are not available.
  • Patients who have previously commenced Niraparib prior to the MONITOR Study opening at the site but are now deceased but will be eligible for retrospective data collection without the need for informed consent.
  • Patients who have previously commenced maintenance Niraparib prior to the MONITOR study opening at the site but have discontinued treatment.
  • Data in respect of AEs, SAEs, ADRs and AESIs will be recorded in Case Report Forms and be identified via the patient's medical records. There is no requirement to complete trial specific SAE reporting forms in this cohort.

Cohort 2: Prospective Cohort

This cohort will include:

  • Patients who have previously commenced maintenance Niraparib prior to the MONITOR study opening at the site and are still receiving Niraparib and in whom quality of life data is available.
  • Patients who are due to commence maintenance Niraparib treatment.

The collection of QoL data, using EQ-5D-5L and EORTC QoL-OV28, FACT-O questionnaires will be mandatory. For patients continuing on Niraparib, data will be collected retrospectively to the point they sign the consent form, and prospectively. Going forward QoL data will not be collected for these patients unless available as part of routine clinical care and baseline QoL is available.

The collection of data relating to adverse events will be mandatory. The scope of adverse events to be recorded includes AEs, SAEs, ADRs and AESIs - see section 5.3.1 for definitions of these events. Details in respect of AEs and SAEs, ADRs and AESIs will be recorded during routine clinic visits or via standard of care contact with the patient.

No additional visits will be required, no study medication will be administrated, and no additional procedures will be performed outside the local routine practice as part of the trial. Patients will be managed and followed up according to routine practice. Only data available in the patient's medical record will be collected. Patients consented to cohort 2 will be asked to complete validated QoL tools; EQ-5D-5L, FACT-O and EORTC QOL-OV28. Approximately 350 patients will be enrolled with an estimated 100 in the retrospective cohort and 250 in the prospective cohort.

Study Type

Observational

Enrollment (Anticipated)

350

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • United Kingdom
      • Bath, United Kingdom, BA1 3NG
      • Belfast, United Kingdom, BT9 7AB
        • Recruiting
        • Belfast Health & Social Care Trust
        • Principal Investigator:
          • Joanne Millar
      • Birmingham, United Kingdom, B15 2TH
        • Recruiting
        • University Hospitals Birmingham NHS Foundation Trust
        • Principal Investigator:
          • Sarah Williams
      • Bristol, United Kingdom, BS2 8ED
        • Recruiting
        • University Hospitals Bristol NHS Foundation Trust
      • Cambridge, United Kingdom, CB2 0QQ
      • Cardiff, United Kingdom, CF14 2TL
        • Recruiting
        • Velindre Cancer Centre, Velindre University NHS Trust
        • Principal Investigator:
          • Emma Hudson
      • Lancaster, United Kingdom
        • Active, not recruiting
        • Morecambe Bay NHS Trust
      • Leeds, United Kingdom, LS9 7TF
        • Recruiting
        • St James's University Hospital
        • Principal Investigator:
          • David Jackson
      • London, United Kingdom, E1 1FR
        • Recruiting
        • Barts Health NHS Trust
        • Principal Investigator:
          • Rowan Miller
      • Northampton, United Kingdom, NN1 5BD
        • Recruiting
        • Northampton General Hospital NHS Trust
      • Northwood, United Kingdom, HA6 2RN
        • Recruiting
        • Mount Vernon Cancer Centre, East and North Hertfordshire NHS Trust
      • Romford, United Kingdom, RM7 0AG
        • Recruiting
        • Queen's Hospital
        • Contact:
        • Principal Investigator:
          • Mary Quigley
      • Southampton, United Kingdom, SO16 5YA
      • Sutton, United Kingdom, SM2 5PT
      • Truro, United Kingdom, TR1 3LJ

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Sampling Method

Non-Probability Sample

Study Population

Patients with advanced ovarian fallopian tube and primary peritoneal cancer, who are/have/ will be receiving Niraparib as maintenance treatment

Description

Inclusion Criteria:

  • Female patient 18 years old or over
  • Patients who are planned to receive Niraparib for advanced ovarian fallopian tube or primary peritoneal cancer,
  • Patients who have previously commenced maintenance Niraparib prior to study opening at site
  • Deceased patients who have previously been prescribed Niraparib
  • Patients able to give written informed consent, complete questionnaires in English and comply with study procedures (if applicable).

Exclusion Criteria:

  • Patients aged <18 years old
  • Patients unable to give informed consent, complete questionnaires in English or comply with study procedures (if applicable).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Cohort 1: Retrospective Cohort

This cohort will include:

  • Patients who have previously commenced maintenance Niraparib prior to the MONITOR study opening at the site and are still receiving Niraparib but in whom quality of life data are not available.
  • Patients who have previously commenced Niraparib prior to the MONITOR Study opening at the site but are now deceased but will be eligible for retrospective data collection without the need for informed consent.
  • Patients who have previously commenced maintenance Niraparib prior to the MONITOR study opening at the site but have discontinued treatment.
  • Data in respect of AEs, SAEs, ADRs and AESIs will be recorded in Case Report Forms and be identified via the patient's medical records. There is no requirement to complete trial specific SAE reporting forms in this cohort.
Other: Niraparib
Niraparib - Niraparib is an oral, highly selective PARP-1 and -2 inhibitor. However, it also inhibits other members of the PARP family, including PARP 3, -4, -10, 12, -14, and -15[13].
Cohort 2: Prospective Cohort

This cohort will include:

  • Patients who have previously commenced maintenance Niraparib prior to the MONITOR study opening at the site and are still receiving Niraparib and in whom quality of life data is available.
  • Patients who are due to commence maintenance Niraparib treatment.
Other: Niraparib
Niraparib - Niraparib is an oral, highly selective PARP-1 and -2 inhibitor. However, it also inhibits other members of the PARP family, including PARP 3, -4, -10, 12, -14, and -15[13].

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Treatment Emergent Adverse Events
Time Frame: February 2020 - August 2022
Proportion of patients with at least one grade ≥3 treatment emergent adverse events (TEAEs)
February 2020 - August 2022

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Treatment history for patients on Niraparib maintenance treatment
Time Frame: February 2020 - February 2024
This will be composed of previous treatment details including duration, delays/ dose modifications.
February 2020 - February 2024
Patient demographics for patients on Niraparib maintenance treatment
Time Frame: February 2020 - February 2024
To describe the patient population of those on Niraparib.
February 2020 - February 2024
Medical history for patients on Niraparib maintenance treatment
Time Frame: February 2020 - February 2024
To ascertain the rationale for patients receiving Niraparib maintenance therapy
February 2020 - February 2024
Routine clinical practice of Niraparib maintenance treatment
Time Frame: February 2020 - February 2024
To detail clinical management of Niraparib maintenance therapy in a real-world pragmatic setting.
February 2020 - February 2024
Time to First Subsequent Therapy (TFST)
Time Frame: February 2020 - February 2024
This will be defined as the date of the start of Niraparib to the start date of the first subsequent anticancer therapy. The treatment prescribed at TFST will also be recorded.
February 2020 - February 2024
Chemotherapy Free Interval (CFI)
Time Frame: February 2020 - February 2024
This will be defined as the time from the last platinum-based chemotherapy dose until initiation of next anticancer therapy (excluding maintenance therapy).
February 2020 - February 2024
Objective Response Rate (ORR)
Time Frame: February 2020 - February 2024
Where indicated for Niraparib treatment, only for patients with measurable disease on baseline imaging. This will be defined as complete or partial response as judged by the investigator.
February 2020 - February 2024
Progression Free Survival (PFS)
Time Frame: January 2022 - February 2024
This will be defined as time from start of Niraparib treatment to progression or death from any cause. Patients without an event will be censored at day of last follow up. Progression will be assessed by the investigator according to routine practice
January 2022 - February 2024
Quality of life for patients on Niraparib maintenance treatment
Time Frame: February 2020 - February 2024
Quality of life (QoL) at protocol-specified time points will be assessed.
February 2020 - February 2024
Adverse events for patients on Niraparib maintenance treatment
Time Frame: February 2020 - February 2024
Number of Adverse Events (AEs), Adverse Drug Reactions (ADRs), Serious Adverse Events (SAEs) and Averse Events of Special lnterest (AESIs)
February 2020 - February 2024

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Royal Marsden NHS Foundation Trust

Investigators

  • Study Chair: Susana Banerjee, MBBS MA PhD FRCP, Royal Marsden NHS Foundation Trust

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

February 3, 2020

Primary Completion (ANTICIPATED)

February 3, 2024

Study Completion (ANTICIPATED)

February 3, 2024

Study Registration Dates

First Submitted

January 13, 2020

First Submitted That Met QC Criteria

March 2, 2020

First Posted (ACTUAL)

March 4, 2020

Study Record Updates

Last Update Posted (ACTUAL)

January 21, 2022

Last Update Submitted That Met QC Criteria

January 5, 2022

Last Verified

January 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CCR4939

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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