Ovarian NeoplasmsNCT05734911
Effectiveness and Safety of Niraparib as First-line Maintenance Therapy for Ovarian Cancer: a Real-world Study
An observational study of Ovarian Neoplasms, run by Zhongda Hospital at 1 site in China.
Trial 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… Read more about this study
- Who is it for?
- Ages 26 to 78 years, women only
- Conditions the study is for
- Ovarian Neoplasms
- What is being tested?
- Niraparib
- Type of treatment
- Pill or oral medicine
- How many people
- 199 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2019to 7 Feb 2023
- How long will I take part?
- 18 Months
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 26 to 78 years
- Women only
- No healthy volunteers
- Adult, Older adult
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
Who may be able to join
- 18 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
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Real-world Data From a Multi-center Study: Insights to the Effectiveness and Safety in Patients With Ovarian Cancer Receiving Niraparib as First-line Maintenance Therapy
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.
Read the detailed description
This is a retrospective multicentric study including 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. The database lock-time was on December 31, 2022. All data were retrieved from the patients' medical records. Clinical data, including patient demographics, clinicopathological characteristics, residual disease after primary surgery, genetic-testing results and so on, were collected. Missing information was supplemented by telephone follow-up or face-to-face inquiries (only for patients who were alive and accessible). The incidence of AEs, as well as dose reductions, dose interruption, and discontinuation of treatment due to AEs were recorded.All analyses were performed on the safety population. The categorical variables were described as a frequency and percentage, and the continuous variables were described as a median and range. No formal sample size calculation was performed since the study was exploratory. Survival analyses were conducted using the Kaplan-Meier method and log-rank test. 95% confidence intervals (CIs) were calculated using the Clopper-Pearson method. Univariate and multivariate Cox regression models were established to determine factors that could affect the PFS for patients receiving niraparib maintenance treatment. Missing data were assigned as unknown for the univariate and multivariate analysis. The method of cox analysis was stepwise regression, and the screening criterion was Akaike Information Criterion (AIC). A P-value of <0.05 was considered statistically significant. Descriptive statistics (number and percentage) were used to summarize the safety data by treatment. Statistical analyses were performed using the R software version 4.2.2 (R Project for Statistical Computing).
- Conditions
- Ovarian Neoplasms
- Being tested
- Niraparib
- Keywords
- niraparib; ovarian cancer; real-world
- Medical subject headings
- Ovarian Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NiraparibDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| 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). Receives: Drug: Niraparib |
What is being measured
The primary outcome is the main question the study is designed to answer.
progression-free survival(PFS)
time from the date of initiation of maintenance therapy with niraparib to the date of disease progression in our study
Measured: up to 29 months
Secondary outcomes (2)
time to treatment discontinuation (TTD)
time from the date of initiation of maintenance therapy with niraparib to the date of treatment discontinuation in our study
Measured: up to 29months
time to first subsequent therapy (TFST)
time from the date of initiation of maintenance therapy with niraparib to the date of first subsequent therapy from any cause in our study
Measured: up to 13 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Feb 2023
- Study start1 Jan 2019
- Primary completion31 Dec 2022
- Study completion7 Feb 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ovarian NeoplasmsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Other
- Enrolment
- 199 participants (actual)
- Target duration
- 18 Months
Sponsor and investigators
- Lead sponsor
- Zhongda Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yang Shen, Zhongda Hospital
- Investigators
- Yang Shen, MD, Study director, Zhongda Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05734911
- Sponsor's protocol ID
- Zhongda-Hospital
- Status last verified
- Feb 2023
- First submitted
- 7 Feb 2023
- Last updated
- 21 Feb 2023
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Real-world Data From a Multi-center Study: Insights to the Effectiveness and Safety in Patients With Ovarian Cancer Receiving Niraparib as First-line Maintenance Therapy
- ClinicalTrials.gov ID
- NCT05734911
- Acronym / sponsor ID
- Zhongda-Hospital
- Conditions
- Ovarian Neoplasms
- Keywords
- niraparib; ovarian cancer; real-world
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 199 participants (actual)
- Lead sponsor
- Zhongda HospitalUniversity, hospital or other
- Study start
- 1 Jan 2019 (actual)
- Primary completion
- 31 Dec 2022 (actual)
- Study completion
- 7 Feb 2023 (actual)
- First posted
- 21 Feb 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
This is a retrospective multicentric study including 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. The database lock-time was on December 31, 2022. All data were retrieved from the patients' medical records. Clinical data, including patient demographics, clinicopathological characteristics, residual disease after primary surgery, genetic-testing results and so on, were collected. Missing information was supplemented by telephone follow-up or face-to-face inquiries (only for patients who were alive and accessible). The incidence of AEs, as well as dose reductions, dose interruption, and discontinuation of treatment due to AEs were recorded.All analyses were performed on the safety population. The categorical variables were described as a frequency and percentage, and the continuous variables were described as a median and range. No formal sample size calculation was performed since the study was exploratory. Survival analyses were conducted using the Kaplan-Meier method and log-rank test. 95% confidence intervals (CIs) were calculated using the Clopper-Pearson method. Univariate and multivariate Cox regression models were established to determine factors that could affect the PFS for patients receiving niraparib maintenance treatment. Missing data were assigned as unknown for the univariate and multivariate analysis. The method of cox analysis was stepwise regression, and the screening criterion was Akaike Information Criterion (AIC). A P-value of <0.05 was considered statistically significant. Descriptive statistics (number and percentage) were used to summarize the safety data by treatment. Statistical analyses were performed using the R software version 4.2.2 (R Project for Statistical Computing).
Study design
- Observational model
- Cohort
- Time perspective
- Other
- Target follow-up
- 18 Months
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| patients with ovarian cancer (OC) received niraparib as first-line (1st-L) maintenance therapy | – | Drug: NiraparibThis 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). |
Who may qualify
- Ages
- 26 to 78 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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
Key inclusion criteria (4 listed)
- 18 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
Key exclusion criteria (3 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| NiraparibWe 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. | Drug | patients with ovarian cancer (OC) received niraparib as first-line (1st-L) maintenance therapy |
Primary outcome
progression-free survival(PFS)
Time frame: up to 29 months
time from the date of initiation of maintenance therapy with niraparib to the date of disease progression in our study
2 secondary outcomes
time to treatment discontinuation (TTD)
Time frame: up to 29months
time to first subsequent therapy (TFST)
Time frame: up to 13 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Feb 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Yang Shen, MD study director
Zhongda Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Ovarian Neoplasms, run by Zhongda Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Feb 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
progression-free survival(PFS) (time frame: up to 29 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Feb 2023.