Trial · NCT06614790
Niraparib Maintenance Treatment in Patients With Newly Diagnosed Advanced Platinum- Sensitive, OC. The First Poland RWE Study.
NCT06614790, Unknown, Pomeranian Medical University Szczecin
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Niraparib Maintenance Treatment in Patients With Newly Diagnosed Advanced Platinum- Sensitive, OC. The First Poland RWE Study. Trials, record NCT06614790. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT06614790
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Niraparib Maintenance Treatment in Patients With Newly Diagnosed Advanced Platinum- Sensitive, OC. The First Poland RWE Study.
- NCT number
- NCT06614790
- Status
- Unknown
- Enrollment
- 300 participants, estimated
- Lead sponsor
- Pomeranian Medical University Szczecin
- Conditions
- Ovarian Cancer
- Interventions
- Niraparib 200/300 MG
- First posted
- 2024-09-26
- Last updated
- 2024-10-23
Source ClinicalTrials.gov
Registered outcomes7
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Safety and tolerability. | 27 months | Safety and tolerability of niraparib treatment in Poland. Strict monitoring of safety profile (e.g. blood test is performed every 7 days during first month of treatment and after each changing of dose, blood pressure is performed every 7 days within the first two months then every month within the first year). |
| Primary | PFS measured from the time of the first dose of niraparib. | 48 months | The primary PFS analysis will be based upon the Investigator's assessment per Response Evaluation Criteria in Solid Tumors (RECIST) v.1.1 criteria, Appendix 2. The day considered as disease progression is the day of the CT examination on which progression was found according to RECIST 1.1 criteria. PFS is defined as the time from first dose of niraparib starting until objective tumor progression or death. |
| Secondary | Chemosensitivity based on KELIM. | 100 days | Chemosensitivity based on KELIM as a surrogate marker for platinum sensitivity to assess for niraparib response as a standard procedure due to the B.50 drug program.I will be measured after the chemotherapy based on CA125 making during the first 100 days of treatment. |
| Secondary | OS (Overall Survival). | 48 months | Overall survival is defined as the time from the start of therapy to the day of patient's death to any cause. |
| Secondary | PFS depending on starting niraparib therapy. | 48 months | Evaluation of outcomes of including patients in therapy up to 4, 8, 12 weeks after completion of platinum-based chemotherapy |
| Secondary | DCR (Disease Control Rate). | 48 months | Disease control rate (DCR) is defined as the percentage of patients who have achieved complete response, partial response, and stable disease to the niraparib intervention. |
| Secondary | TFST (Time to the First Subsequent Therapy). | 48 months | TFST is defined as the time from initiation of first-line chemotherapy until the start of subsequent therapy or death. |
Source ClinicalTrials.gov
Outcomes0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
None in this release.
Results by group0
Each measurement the trial posted, group by group, in the words and numbers it posted.
None in this release.
Participant flow0
How many started, completed or left each group, period by period.
None in this release.
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals0
The totals the trial posted for each group.
None in this release.
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT06614790
GET https://conductscience.org/api/trials/v1/NCT06614790/registered