Ignite Creation Date:
2024-10-26 @ 3:41 PM
Last Modification Date:
2024-10-26 @ 3:41 PM
Study NCT ID:
NCT06614790
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-09-13
Brief Title:
Niraparib Maintenance Treatment in Patients With Newly Diagnosed Advanced Platinum- Sensitive OC The First Poland RWE Study
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Patient Outcomes and Safety of Niraparib as Maintenance Treatment in Patients With Newly Diagnosed Advanced Platinum- Sensitive Ovarian Cancer The First Real-World Evidence Study From Poland
Status:
RECRUITING
Status Verified Date:
2024-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
NIRAPARIB
Brief Summary:
The study is observational not interventional The study will include patients with advanced ovarian cancer who have been treated in Poland based on a previous early access program and who are currently being treated under the B50 drug program funded by the National Health Fund
Only patients currently being treated in the B50 program at 10 selected centers listed on this site may be included in the study
Of course any patient in Poland eligible for maintenance treatment with niraparib can receive the drug regardless of participation in this RWE studyThe treatment involves administering niraparib as maintenance therapy for 3 years after the completion of chemotherapy provided that the patient has responded to systemic treatment NED CR PR
Only patients currently being treated in the B50 program at 10 selected centers listed on this site may be included in the study
Of course any patient in Poland eligible for maintenance treatment with niraparib can receive the drug regardless of participation in this RWE studyThe treatment involves administering niraparib as maintenance therapy for 3 years after the completion of chemotherapy provided that the patient has responded to systemic treatment NED CR PR
Detailed Description:
Although over the last 2 decades the surgical management of ovarian cancer has improved with more chemotherapy options are available however 5-year survival rates have remained relatively stable at 25 to 40 36 The proposed real-life observation study can deliver valuable real-world information about niraparib patient outcomes and safety complementing the results of the PRIMA and PRIME clinical trials This will also include establishing the importance of KELIM as a predictor of maintenance therapy choices The multicenter design of the study will allow collection of data from a relatively large and representative group of patients within the Polish Drug program B50 To this time no study has been published about niraparib patient outcomes and safety in Poland
This study will also include evaluation of patient outcomes when initiating therapy up to 4 8 12 weeks after completion of platinum based chemotherapy
The population of patients included in the study will come from two programs EAP and B50
EAP is an early access program sponsored by GSK which has been operating in Poland since 2021 Jan The inclusion criteria for EAP contained the same measurable parameters as the B50 drug program offers
The B50 drug program is a ministerial program guaranteeing the Polish patients with advanced ovarian cancer access to approved medicines like maintenance treatment with PARP inhibitors including niraparib
The B50 and EAP inclusion criteria are in accordance with the study protocol
Primary Objective
Primary objectives will be to describe patient and disease characteristics for patients receiving niraparib treatment in Poland
To quantify PFS the primary PFS analysis will be based upon the Investigators assessment per Response Evaluation Criteria in Solid Tumors RECIST v11 criteria Appendix 2 The day considered as disease progression is the day of the CT examination on which progression was found according to RECIST 11 criteria
PFS measured from the time of the first dose of niraparib
Primary objectives will also estimate safety and tolerability of niraparib treatment in Poland Strict monitoring of safety profile eg 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
Secondary Objectives
OS Overall Survival
Chemosensitivity based on KELIM as a surrogate marker for platinum sensitivity to assess for niraparib response as a standard procedure due to the B50 drug program
Evaluation of outcomes of including patients in therapy up to 4 8 12 weeks after completion of platinum-based chemotherapy
TFST Time to the First Subsequent Therapy
DCR Disease Control Rate
INVESTIGATIONAL PLAN
Overall Study Design Patients who complete the Chemotherapy Treatment Period without progressive disease CR PR NED will start Maintenance Treatment with niraparib after Cycle 6 up to 12 weeks after completion of the chemotherapy
Prior to receiving oral maintenance treatment patients must have a CBC that demonstrates adequate recovery from hematologic toxicity from chemotherapy
Absolute neutrophil count 1500 cellsμL
Platelet count 100000 cellsμL
Hemoglobin 10 gdl
Number of Patients and Study Design We expect to enroll approximately 300 patients from about 10 sites Treatment part of study
Part I- looking retrospectively at the time period JAN 2021-MAR 2023 The retrospective data will include patients who are enrolled in niraparib treatment
under the EAP started in JAN 2021 in continuation
under the B50 drug program which began in January 2022 Of note the retrospective multi-center observational study will involve about 30 patients treated with niraparib in EAP FIGO III R0 after PDS included and patients who were treated with niraparib before starting RWE about 120 pts JAN 2021- MAR 2023 by the drug program B50 which has been started to adapt on 1st of Jan 2022
FIGO III PDS to R0 patients are included to this study Part II- looking prospectively at the time period APR 2023 to DEC 2025 The prospective data will include patients who are enrolled in niraparib treatment under the B50 drug program
The prospective multi-center observational study will involve about 150 patients with ovarian cancer OC who have been treated in about 10 OC gyn- oncocenters in Poland OCgoC APR 2023- DEC 2025
Study follow up Part III- survival follow up after treatment part of study from JAN 2026 - DEC 2026
Chemotherapy Treatment Period Not covered by the study protocol
Maintenance Treatment Period All the patients will be given a sequential number by the system Additionally each patient from the EAP will have individual number which was given to them In the CRF there will be additional information that there is a patient in the EAP phase of the study Patients who have responded to first-line chemotherapy NED CR PR and with recovery to baseline of any hematologic toxicities will enter the Maintenance Treatment Period Oral niraparib will be dispensed to patients on Day 1 of every 28-day cycle beginning with Cycle 1 of the Maintenance Treatment Period for up to 3 years in the absence of PD unacceptable toxicity or patient withdrawal or based on Investigators decision
The recommended dose is 200 mg per day 2 capsules Patients with a baseline body weight of 77 kg and baseline platelet count of 150000 cellsμL will take 3 capsules of 100 mg strength 300 mgday at each dose administration
Dose modifications will not be based upon changes in the patients actual body weight during their study participation
The inclusion criteria the way of monitoring both in a prospective and a retrospective cohort will be followed by the B50 drug program criteria For that reason CA125 measurements necessary for KELIM as well as RECIST data are available in both cohorts during the whole period of time
Duration of Treatment Patients may continue niraparib treatment for up to 3 years according to the B50 drug program
This study will also include evaluation of patient outcomes when initiating therapy up to 4 8 12 weeks after completion of platinum based chemotherapy
The population of patients included in the study will come from two programs EAP and B50
EAP is an early access program sponsored by GSK which has been operating in Poland since 2021 Jan The inclusion criteria for EAP contained the same measurable parameters as the B50 drug program offers
The B50 drug program is a ministerial program guaranteeing the Polish patients with advanced ovarian cancer access to approved medicines like maintenance treatment with PARP inhibitors including niraparib
The B50 and EAP inclusion criteria are in accordance with the study protocol
Primary Objective
Primary objectives will be to describe patient and disease characteristics for patients receiving niraparib treatment in Poland
To quantify PFS the primary PFS analysis will be based upon the Investigators assessment per Response Evaluation Criteria in Solid Tumors RECIST v11 criteria Appendix 2 The day considered as disease progression is the day of the CT examination on which progression was found according to RECIST 11 criteria
PFS measured from the time of the first dose of niraparib
Primary objectives will also estimate safety and tolerability of niraparib treatment in Poland Strict monitoring of safety profile eg 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
Secondary Objectives
OS Overall Survival
Chemosensitivity based on KELIM as a surrogate marker for platinum sensitivity to assess for niraparib response as a standard procedure due to the B50 drug program
Evaluation of outcomes of including patients in therapy up to 4 8 12 weeks after completion of platinum-based chemotherapy
TFST Time to the First Subsequent Therapy
DCR Disease Control Rate
INVESTIGATIONAL PLAN
Overall Study Design Patients who complete the Chemotherapy Treatment Period without progressive disease CR PR NED will start Maintenance Treatment with niraparib after Cycle 6 up to 12 weeks after completion of the chemotherapy
Prior to receiving oral maintenance treatment patients must have a CBC that demonstrates adequate recovery from hematologic toxicity from chemotherapy
Absolute neutrophil count 1500 cellsμL
Platelet count 100000 cellsμL
Hemoglobin 10 gdl
Number of Patients and Study Design We expect to enroll approximately 300 patients from about 10 sites Treatment part of study
Part I- looking retrospectively at the time period JAN 2021-MAR 2023 The retrospective data will include patients who are enrolled in niraparib treatment
under the EAP started in JAN 2021 in continuation
under the B50 drug program which began in January 2022 Of note the retrospective multi-center observational study will involve about 30 patients treated with niraparib in EAP FIGO III R0 after PDS included and patients who were treated with niraparib before starting RWE about 120 pts JAN 2021- MAR 2023 by the drug program B50 which has been started to adapt on 1st of Jan 2022
FIGO III PDS to R0 patients are included to this study Part II- looking prospectively at the time period APR 2023 to DEC 2025 The prospective data will include patients who are enrolled in niraparib treatment under the B50 drug program
The prospective multi-center observational study will involve about 150 patients with ovarian cancer OC who have been treated in about 10 OC gyn- oncocenters in Poland OCgoC APR 2023- DEC 2025
Study follow up Part III- survival follow up after treatment part of study from JAN 2026 - DEC 2026
Chemotherapy Treatment Period Not covered by the study protocol
Maintenance Treatment Period All the patients will be given a sequential number by the system Additionally each patient from the EAP will have individual number which was given to them In the CRF there will be additional information that there is a patient in the EAP phase of the study Patients who have responded to first-line chemotherapy NED CR PR and with recovery to baseline of any hematologic toxicities will enter the Maintenance Treatment Period Oral niraparib will be dispensed to patients on Day 1 of every 28-day cycle beginning with Cycle 1 of the Maintenance Treatment Period for up to 3 years in the absence of PD unacceptable toxicity or patient withdrawal or based on Investigators decision
The recommended dose is 200 mg per day 2 capsules Patients with a baseline body weight of 77 kg and baseline platelet count of 150000 cellsμL will take 3 capsules of 100 mg strength 300 mgday at each dose administration
Dose modifications will not be based upon changes in the patients actual body weight during their study participation
The inclusion criteria the way of monitoring both in a prospective and a retrospective cohort will be followed by the B50 drug program criteria For that reason CA125 measurements necessary for KELIM as well as RECIST data are available in both cohorts during the whole period of time
Duration of Treatment Patients may continue niraparib treatment for up to 3 years according to the B50 drug program
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None