Effectiveness and Safety of Niraparib as First-line Maintenance Therapy for Ovarian Cancer: a Real-world Study

NCT05734911 | Completed FDA Drug

• 1 other identifier: Zhongda-Hospital
• Study Type: observational
• Target: 199
• Locations: 1 country
• Sites: 1

Brief Summary

In order to explore the real situation of niraparib in clinical application more comprehensively and deeply, we conducted the first multicenter, real-world study in China. This large observational study used real-world data to assess the effectiveness and safety of niraparib as maintenance therapy in patients with advanced ovarian cancer (AOC) in China and investigated clinical factors associated with prolonged benefits of niraparib so as to achieve the maximum clinical benefit of patients.

Conditions

Ovarian Neoplasms

Keywords

niraparib; ovarian cancer; real-world

Outcome Measures

Primary Outcomes (1)

• progression-free survival(PFS)

  time from the date of initiation of maintenance therapy with niraparib to the date of disease progression in our study

  up to 29 months

Secondary Outcomes (2)

• time to treatment discontinuation (TTD)

  up to 29months

• time to first subsequent therapy (TFST)

  up to 13 months

Study Arms (1)

patients with ovarian cancer (OC) received niraparib as first-line (1st-L) maintenance therapy

This multi-center, observational, retrospective study collected real-world medical record data of patients with advanced ovarian cancer treated with niraparib as first-line maintenance therapy from fourteen hospitals in China. In reality, these patients received different oral doses of niraparib until disease progression, severe toxicity occurred, or death. A total of 199 patients were included in a centralized database ultimately with a median age of 57.0 years (range, 51.0-63.5 years).

Drug: Niraparib

Interventions

Niraparib DRUG

We did not set a fixed starting dose and strict medication standard,compared with a randomized controlled trial.In our study,enrolled patients received different oral doses of niraparib until disease progression, severe toxicity occurred, or death in reality. We were interested in the dose adjustment and duration of niraparib in real world.

patients with ovarian cancer (OC) received niraparib as first-line (1st-L) maintenance therapy

Eligibility Criteria

• Age: 26 Years - 78 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

advanced ovarian cancer patients that have used niraparib as first-line maintenance therapy after chemotherapy from fourteen hospitals in China between January 2019 and December 2021

You may qualify if:

• years of age or older
• diagnosed with histologically confirmed ovarian cancer (International Federation of Gynecology and Obstetrics \[FIGO\] Stage II-IV)
• underwent surgery and first-line chemotherapy and were treated with niraparib as maintenance therapy
• the date to start maintenance therapy with niraparib is from January 2019 to December 2021

You may not qualify if:

• had experienced other malignancies within the previous 5 years
• enrolled in clinical trials in which investigators were blinded to the treatments
• with a previous or current diagnosis of myelodysplastic syndrome (MDS) or acute myeloid leukemia (AML)

Sponsors & Collaborators

• Zhongda Hospital: lead

Study Sites (1)

Zhongda hospital

Nanjing, 210009, China

Location

MeSH Terms

Conditions

Ovarian Neoplasms

Interventions

niraparib

Condition Hierarchy (Ancestors)

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

Study Officials

• Yang Shen, MD

  Zhongda Hospital

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: OTHER
• Target Duration: 18 Months
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Department of Obstetrics and Gynaecology, Zhongda Hospital, School of Medicine, Southeast University

Study Record Dates

• First Submitted: February 7, 2023
• First Posted: February 21, 2023
• Study Start: January 1, 2019
• Primary Completion: December 31, 2022
• Study Completion: February 7, 2023
• Last Updated: February 21, 2023

Record last verified: 2023-02

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)