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Real-world Study of Niraparib Maintenance Treatment in Patients With Newly Diagnosed Ovarian Cancer (RENI-1)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04986371
Recruitment Status : Not yet recruiting
First Posted : August 2, 2021
Last Update Posted : August 2, 2021
Sponsor:
Information provided by (Responsible Party):
Ling-Ying Wu, Chinese Academy of Medical Sciences

Brief Summary:
This is an open-label, single-arm, multi-center、non-interventional real-world study, which evaluate treatment pattern, safety and efficacy of Niraparib as first-line maintenance treatment for Chinese patient with newly diagnosed ovarian cancer , fallopian tube cancer, and primary peritoneal cancer in real world clinical practice.

Condition or disease Intervention/treatment
Epithelial Ovarian Cancer Drug: Niraparib

Detailed Description:
In this study, 300 patients will be enrolled. Eligible patients will be those with histologically confirmed epithelial ovarian cancer, carcinoma of fallopian tube or primary peritoneal carcinoma. Patients must have received one line of platinum-based chemotherapy, and be in clinically complete or partial response following the platinum-based chemotherapy prior to enrollment in the study. Patients will be treated with Niraparib according to the physician's judgement till disease progression, discontinuation for other reasons or death. The primary endpoint is treatment pattern of Niraparib as first-line maintenance treatment for ovarian cancer patients. The second endpoints include AE, PFS and quality of life.

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Study Type : Observational
Estimated Enrollment : 300 participants
Observational Model: Other
Time Perspective: Prospective
Official Title: An Observational, Non-interventional Study of Niraparib Maintenance Treatment in Patients With Ovarian Cancer After Frontline Platinum-based Chemotherapy
Estimated Study Start Date : August 10, 2021
Estimated Primary Completion Date : August 31, 2022
Estimated Study Completion Date : February 28, 2025



Intervention Details:
  • Drug: Niraparib
    Usage following drug insert is recommended
    Other Name: Zejula


Primary Outcome Measures :
  1. Starting dose of Niraparib [ Time Frame: up to 3 years ]
    Record the starting dose of Niraparib in real clinical practice

  2. Percentage of patients who have taken dose adjustment and the reason of dose adjustment [ Time Frame: up to 3 years ]
    Record the percentage of patients who have taken dose adjustment and the reason of dose adjustment

  3. Percentage of patients who have taken dose discontinuation and the reason of dose discontinuation [ Time Frame: up to 3 years ]
    Record the percentage of patients who have taken dose discontinuation and the reason of dose discontinuation

  4. Concomitant treatments which patients take along with Niraparib [ Time Frame: up to 3 years ]
    Record the concomitant treatments (drugs, or other tumor treatments) which patients take along with Niraparib


Secondary Outcome Measures :
  1. Incidence of all AEs [ Time Frame: up to 3 years ]
    Incidence of all AEs based upon CTCAE version 5.0 during subjects receiving the study treatment.

  2. Progression-free survival (PFS) [ Time Frame: up to 3 years ]
    Progression-free survival is defined as the time from the last day of previous chemotherapy to first documentation of tumor progression, or to death due to any cause in the absence of previous documentation of objective tumor progression.

  3. Time to First Subsequent Therapy (TFST) [ Time Frame: up to 3 years ]
    The TFST was defined as the time from the last day of previous chemotherapy to the start date of the first subsequent anti-cancer therapy or death.

  4. Chemotherapy-Free Interval (CFI) [ Time Frame: up to 3 years ]
    CFI was defined as the time to the initiation of the next anti-cancer therapy after maintenance treatment.

  5. Overall Survival (OS) [ Time Frame: up to 3 years ]
    Overall survival is defined as the date of the last day of previous chemotherapy to the date of death by any cause.

  6. Change From Baseline in EQ-5D-5L [ Time Frame: up to 3 years ]
    EQ-5D-5L is a well-validated, general preference-based, health-related QoL instrument. The EQ-5D-5L encompasses 5 domains, asking patients to rate their perceived health state today on the following dimensions: Mobility, Self-Care, Usual Activities, Pain/Discomfort, and Anxiety/Depression. Each domain has 5 possible levels: "no problems" (Level 1), "slight problems" (Level 2), "moderate problems" (Level 3), "severe problems" (Level 4), and "extreme problems" (Level 5). Each domain is assigned a level, and levels are combined to create a 5-digit number describing the patient's health state. For each patient, an index value is determined from a published country-specific value set. This index value or utility score ranges from 0 to 1.00 (with 1.0 representing perfect health) and is used in the calculation of quality-adjusted life years (QALYs) that are used to inform economic valuations of health interventions. A positive change from baseline indicates improvement.


Biospecimen Retention:   Samples With DNA
Tumor tissue, peripheral blood


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients with newly diagnosed ovarian cancer
Criteria

Inclusion Criteria:

  • Women aged 18 years or older
  • Histologically confirmed epithelial ovarian cancer, carcinoma of fallopian tube or primary peritoneal carcinoma
  • Having received one line of platinum-based chemotherapy, and clinically CR or PR to this line of chemotherapy
  • Understand the protocol, and Written informed consent before any study-related procedure

Exclusion Criteria:

  • Participating in other clinical trials at the same time
  • Having sever or uncontrolled diseases that will influence the study, according to the judgement of investigators
  • Having other malignant tumors (other than breast cancer with BRCA mutation)
  • Pregnancy or breast feeding, or planning a pregnancy during the study
  • Unable to visit on time
  • Patients who are allergic to the study drug or drug components

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): NCT04986371


Contacts
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Contact: Lingying Wu 010-87788996 wulingying@csco.org.cn

Sponsors and Collaborators
Ling-Ying Wu
Investigators
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Principal Investigator: Lingying Wu Cancer Institute and Hospital, Chinese Academy of Medical Sciences
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Responsible Party: Ling-Ying Wu, Professor, Chinese Academy of Medical Sciences
ClinicalTrials.gov Identifier: NCT04986371    
Other Study ID Numbers: 21/251-2922
First Posted: August 2, 2021    Key Record Dates
Last Update Posted: August 2, 2021
Last Verified: July 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Ovarian Neoplasms
Carcinoma, Ovarian Epithelial
Endocrine Gland Neoplasms
Neoplasms by Site
Neoplasms
Ovarian Diseases
Adnexal Diseases
Genital Diseases, Female
Female Urogenital Diseases
Female Urogenital Diseases and Pregnancy Complications
Urogenital Diseases
Genital Neoplasms, Female
Urogenital Neoplasms
Genital Diseases
Endocrine System Diseases
Gonadal Disorders
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Niraparib
Poly(ADP-ribose) Polymerase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents