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

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ClinicalTrials.gov Identifier: NCT04295577
Recruitment Status : Active, not recruiting
First Posted : March 4, 2020
Last Update Posted : April 8, 2020
Sponsor:
Information provided by (Responsible Party):
Royal Marsden NHS Foundation Trust

Brief Summary:
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.

Condition or disease Intervention/treatment
Ovarian Cancer Peritoneal Cancer Fallopian Tube Cancer Other: Niraparib

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 15 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 200 patients will be enrolled with an estimated 50 in the retrospective cohort and 150 in the prospective cohort.

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Study Type : Observational
Estimated Enrollment : 200 participants
Observational Model: Cohort
Time Perspective: Other
Official Title: Multi-Centre Observational Study of Maintenance Niraparib in Treatment of Ovarian CanceR: UK Routine Clinical Practice Experience
Actual Study Start Date : February 3, 2020
Estimated Primary Completion Date : February 3, 2022
Estimated Study Completion Date : August 3, 2022


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].




Primary Outcome Measures :
  1. Treatment Emergent Adverse Events [ Time Frame: February 2020 - August 2022 ]
    Proportion of patients with at least one grade ≥3 treatment emergent adverse events (TEAEs)


Secondary Outcome Measures :
  1. Treatment history for patients on Niraparib maintenance treatment [ Time Frame: February 2020 - August 2021 ]
    This will be composed of previous treatment details including duration, delays/ dose modifications.

  2. Patient demographics for patients on Niraparib maintenance treatment [ Time Frame: February 2020 - August 2021 ]
    To describe the patient population of those on Niraparib.

  3. Medical history for patients on Niraparib maintenance treatment [ Time Frame: February 2020 - August 2021 ]
    To ascertain the rationale for patients receiving Niraparib maintenance therapy

  4. Routine clinical practice of Niraparib maintenance treatment [ Time Frame: February 2020 - August 2022 ]
    To detail clinical management of Niraparib maintenance therapy in a real-world pragmatic setting.

  5. Time to First Subsequent Therapy (TFST) [ Time Frame: February 2020 - August 2022 ]
    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.

  6. Chemotherapy Free Interval (CFI) [ Time Frame: February 2020 - August 2022 ]
    This will be defined as the time from the last platinum-based chemotherapy dose until initiation of next anticancer therapy (excluding maintenance therapy).

  7. Objective Response Rate (ORR) [ Time Frame: February 2020 - August 2022 ]
    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.

  8. Quality of life for patients on Niraparib maintenance treatment [ Time Frame: February 2020 - August 2022 ]
    Quality of life (QoL) at protocol-specified time points will be assessed.

  9. Adverse events for patients on Niraparib maintenance treatment [ Time Frame: February 2020 - August 2022 ]
    Number of Adverse Events (AEs), Adverse Drug Reactions (ADRs), Serious Adverse Events (SAEs) and Averse Events of Special lnterest (AESIs)



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Gender Eligibility Description:   Female
Accepts Healthy Volunteers:   No
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
Criteria

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).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04295577


Locations
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United Kingdom
Royal Marsden NHS Foundation Trust
Sutton, United Kingdom, SM2 5PT
Sponsors and Collaborators
Royal Marsden NHS Foundation Trust
Investigators
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Study Chair: Susana Banerjee, MBBS MA PhD FRCP Royal Marsden NHS Foundation Trust
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Responsible Party: Royal Marsden NHS Foundation Trust
ClinicalTrials.gov Identifier: NCT04295577    
Other Study ID Numbers: CCR4939
First Posted: March 4, 2020    Key Record Dates
Last Update Posted: April 8, 2020
Last Verified: March 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Royal Marsden NHS Foundation Trust:
Niraparib
Additional relevant MeSH terms:
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Ovarian Neoplasms
Carcinoma, Ovarian Epithelial
Fallopian Tube Neoplasms
Endocrine Gland Neoplasms
Neoplasms by Site
Neoplasms
Ovarian Diseases
Adnexal Diseases
Genital Diseases, Female
Genital Neoplasms, Female
Urogenital Neoplasms
Endocrine System Diseases
Gonadal Disorders
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Fallopian Tube Diseases
Niraparib
Poly(ADP-ribose) Polymerase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents