A Maintenance Study with Niraparib versus placebo in patients with Platinum sensitive ovarian cancer
Trial overview
Progression-Free Survival (PFS) in Cohort With Germline BReast CAncer gene (BRCA) Mutation (gBRCA)
Timeframe: From date of randomization to the earliest date of disease progression or death from any cause, up to 7 years 7 months and 4 days
Progression-Free Survival (PFS) in Cohort with No Germline BCRA with homologous recombination deficiency-positive (HRD+) tumors (non-gBRCAmut HRD+)
Timeframe: From date of randomization to the earliest date of disease progression or death from any cause, up to 7 years, 7 months and 4 days
Progression-Free Survival (PFS) in Cohort with No Germline BRCA Mutation
Timeframe: From date of randomization to the earliest date of disease progression or death from any cause, up to 7 years, 7 months and 4 days
Time to First Subsequent Therapy in Cohort With Germline BRCA Mutation (gBRCA)
Timeframe: From date of randomization to the earliest date of first subsequent therapy or death, up to 7 years, 7 months and 4 days
Time to First Subsequent Therapy in Cohort With No Germline BRCA Mutation
Timeframe: From date of randomization to the earliest date of first subsequent therapy or death, up to 7 years, 7 months and 4 days
Chemotherapy-Free Interval in Cohort With Germline BRCA Mutation (gBRCA)
Timeframe: From date of last platinum therapy prior to randomization to the initiation of the next anti-cancer therapy after maintenance treatment, up to 7 years, 7 months and 4 days
Chemotherapy-Free Interval in Cohort With No Germline BRCA Mutation
Timeframe: From date of last platinum therapy prior to randomization to the initiation of the next anti-cancer therapy after maintenance treatment, up to 7 years, 7 months and 4 days
Progression-Free Survival 2 in Cohort With Germline BRCA Mutation (gBRCA)
Timeframe: From treatment randomization to the earlier of the date of disease progression on the next anti-cancer therapy following study treatment or death due to any cause, up to 7 years, 7 months and 4 days
Progression-Free Survival 2 in Cohort With No Germline BRCA Mutation
Timeframe: From treatment randomization to the earlier of the date of disease progression on the next anti-cancer therapy following study treatment or death due to any cause, up to 7 years, 7 months and 4 days
Overall Survival in Cohort With Germline BRCA Mutation (gBRCA)
Timeframe: From treatment randomization to date of death by any cause, up to 7 years, 7 months and 4 days
Overall Survival in Cohort With No Germline BRCA Mutation
Timeframe: From treatment randomization to date of death by any cause, up to 7 years, 7 months and 4 days
Time to Second Subsequent Therapy in Cohort With Germline BRCA Mutation (gBRCA)
Timeframe: From the date of randomization to the start date of the second subsequent anti-cancer therapy, up to 7 years, 7 months and 4 days
Time to Second Subsequent Therapy in Cohort With No Germline BRCA Mutation
Timeframe: From the date of randomization to the start date of the second subsequent anti-cancer therapy, up to 7 years, 7 months and 4 days
Change From Baseline in Functional Assessment of Cancer Therapy-Ovarian Symptom Index in Cohort With Germline BRCA at Cycle 2
Timeframe: Baseline (pre-dose on Day 1) and at Cycle 2 (Each cycle was of 28 days)
Change From Baseline in Functional Assessment of Cancer Therapy-Ovarian Symptom Index in Cohort With Germline BRCA at Cycle 4
Timeframe: Baseline (Pre-dose on Day 1) and at Cycle 4 (Each cycle was of 28 days)
Change From Baseline in Functional Assessment of Cancer Therapy-Ovarian Symptom Index in Cohort With Germline BRCA at Cycle 6
Timeframe: Baseline (pre-dose on Day 1) and at Cycle 6 (Each cycle was of 28 days)
Change From Baseline in Functional Assessment of Cancer Therapy-Ovarian Symptom Index in Cohort With Germline BRCA at post-progression
Timeframe: Baseline (Pre-dose on Cycle 1 Day 1, Each cycle was of 28 days) and up to 7 years, 7 months and 4 days
Change From Baseline in Functional Assessment of Cancer Therapy-Ovarian Symptom Index in Cohort With no Germline BRCA at Cycle 2
Timeframe: Baseline (Pre-dose on Day 1) and at Cycle 2 (Each cycle was of 28 days)
Change From Baseline in Functional Assessment of Cancer Therapy-Ovarian Symptom Index in Cohort With no Germline BRCA at Cycle 4
Timeframe: Baseline (Pre-dose on Day 1) and at Cycle 4 (Each cycle was of 28 days)
Change From Baseline in Functional Assessment of Cancer Therapy-Ovarian Symptom Index in Cohort With no Germline BRCA at Cycle 6
Timeframe: Baseline (Pre-dose on Day 1) and at Cycle 6 (Each cycle was of 28 days)
Change From Baseline in Functional Assessment of Cancer Therapy-Ovarian Symptom Index in Cohort With no Germline BRCA at post-progression
Timeframe: Baseline (Pre-dose on Day 1) and up to 7 years, 7 months and 4 days
Change From Baseline in European Quality of Life Scale, 5-Dimensions (EQ-5D-5L) in Cohort With Germline BRCA at Cycle 2
Timeframe: Baseline (Pre-dose on Day 1) and at Cycle 2 (Each cycle was of 28 days)
Change From Baseline in EQ-5D-5L in Cohort With Germline BRCA at Cycle 4
Timeframe: Baseline (Pre-dose on Day 1) and at Cycle 4 (Each cycle was of 28 days)
Change From Baseline in EQ-5D-5L in Cohort With Germline BRCA at Cycle 6
Timeframe: Baseline (Pre-dose on Day 1) and at Cycle 6 (Each cycle was of 28 days)
Change From Baseline in EQ-5D-5L in Cohort With Germline BRCA at post-progression
Timeframe: Baseline (Pre-dose on Day 1) and up to 7 years, 7 months and 4 days
Change From Baseline in EQ-5D-5L in Cohort With no Germline BRCA at Cycle 2
Timeframe: Baseline (Pre-dose on Day 1) and at Cycle 2 (Each cycle was of 28 days)
Change From Baseline in EQ-5D-5L in Cohort With no Germline BRCA at Cycle 4
Timeframe: Baseline (Pre-dose on Day 1) and at Cycle 4 (Each cycle was of 28 days)
Change From Baseline in EQ-5D-5L in Cohort With no Germline BRCA at Cycle 6
Timeframe: Baseline (Pre-dose on Day 1) and at Cycle 6 (Each cycle was of 28 days)
Change From Baseline in EQ-5D-5L in Cohort With no Germline BRCA at post-progression
Timeframe: Baseline (Pre-dose on Day 1) and up to 7 years, 7 months and 4 days
Number of participants with response to Neuropathy questionnaire in Cohort With Germline BRCA at Baseline
Timeframe: At Baseline
Number of participants with response to Neuropathy questionnaire in Cohort With Germline BRCA at Cycle 2
Timeframe: At Cycle 2 (Each cycle was of 28 days)
Number of participants with response to Neuropathy questionnaire in Cohort With Germline BRCA at Cycle 4
Timeframe: At Cycle 4 (Each cycle was of 28 days)
Number of participants with response to Neuropathy questionnaire in Cohort With Germline BRCA at Cycle 6
Timeframe: At Cycle 6 (Each cycle was of 28 days)
Number of participants with response to Neuropathy questionnaire in Cohort With Germline BRCA at post-progression
Timeframe: Up to 7 years, 7 months and 4 days
Number of participants with response to Neuropathy questionnaire in Cohort With no Germline BRCA at Baseline
Timeframe: At Baseline
Number of participants with response to Neuropathy questionnaire in Cohort With no Germline BRCA at Cycle 2
Timeframe: At Cycle 2 (Each cycle was of 28 days)
Number of participants with response to Neuropathy questionnaire in Cohort With no Germline BRCA at Cycle 4
Timeframe: At Cycle 4 (Each cycle was of 28 days)
Number of participants with response to Neuropathy questionnaire in Cohort With no Germline BRCA at Cycle 6
Timeframe: At Cycle 6 (Each cycle was of 28 days)
Number of participants with response to Neuropathy questionnaire in Cohort With no Germline BRCA at post-progression
Timeframe: Up to 7 years, 7 months and 4 days
Number of participants with concordance of a candidate companion BRAC analysis diagnostic test compared to the centralized BRCA mutation test used in this study
Timeframe: Up to 7 years, 7 months and 4 days
Number of participants with concordance of a candidate companion HRD diagnostic test compared to the HRD test used in this study
Timeframe: Up to 7 years, 7 months and 4 days
Number of participants with non-serious adverse events (AEs) and serious AEs (SAEs)
Timeframe: Up to 7 years, 7 months and 6 days
Number of participants with non-serious AEs and SAEs in FE sub-study
Timeframe: Up to 2 years, 3 months and 11 days
Number of participants with non-serious AEs and SAEs in QTc sub-study
Timeframe: Up to 5 years 10 months and 22 days
Area under the plasma concentration-time curve from time 0 extrapolated to infinity (AUC[0-infinity]) following administration of Niraparib (FE sub-study)
Timeframe: Pre-dose and at 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 48, 72, 96, 120 hours post dose
Area under the plasma concentration-time curve from time 0 to the last quantifiable concentration (AUC[0-last]) following administration of Niraparib (FE sub-study)
Timeframe: Pre-dose (Day -1) and at 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 48, 72, 96, 120 hours post dose
Maximum observed plasma concentration (Cmax) following administration of Niraparib (FE sub-study)
Timeframe: Pre-dose (Day -1) and at 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 48, 72, 96, 120 hours post dose
Time to reach maximum (tmax) following administration of Niraparib (FE sub-study)
Timeframe: Pre-dose (Day -1) and at 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 48, 72, 96, 120 hours post dose
Terminal elimination half-life (t1/2) following administration of Niraparib (FE sub-study)
Timeframe: Pre-dose (Day -1) and at 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 48, 72, 96, 120 hours post dose
Number of participants with maximum post-Baseline QT Interval Corrected by Fridericia's Formula (QTcF) greater than pre-specified thresholds
Timeframe: At Baseline (Cycle 1 Day 1, each cycle was of 28 days)
Participation criteria
- 18 years of age or older, female, any race
- Histologically diagnosed ovarian cancer, fallopian tube cancer or primary peritoneal cancer
- Known hypersensitivity to the components of niraparib
- Invasive cancer other than ovarian cancer within 2 years (except basal or squamous cell carcinoma of the skin that has been definitely treated)
•18 years of age or older, female, any race •Histologically diagnosed ovarian cancer, fallopian tube cancer or primary peritoneal cancer •High grade (or grade 3) serous histology or known to have gBRCAmut •Has received at least 2 previous courses of platinum-containing therapy, and has disease that was considered platinum sensitive following the penultimate (next to last) platinum course (more than 6 month period between penultimate platinum regimen and progression of disease) •Has responded to last the platinum regimen, remains in response and is enrolled on study within 8 weeks of completion of the last platinum regimen •ECOG 0-1 •Adequate bone marrow, kidney and liver function
•Known hypersensitivity to the components of niraparib •Invasive cancer other than ovarian cancer within 2 years (except basal or squamous cell carcinoma of the skin that has been definitely treated) •Symptomatic uncontrolled brain metastasis •Is pregnant or breast feeding •Immunocompromised patients •Known active hepatic disease •Prior treatment with a known PARP inhibitor
Trial location(s)
Study documents
If you wish to request for full study report, please contact - [email protected]
Results overview
Results posted on ClinicalTrials.gov
Plain language summaries
Plain language summaries of clinical trial results for Phase 2-4 clinical trials that were initiated on or after January 2022 will be posted by GSK within one year following study completion.