TriangleNCT01847274 · CITED IN SOURCE DOCUMENTS
A Maintenance Study With Niraparib Versus Placebo in Patients With Platinum Sensitive Ovarian Cancer
An NCI or FDA source cites this study. A citation does not establish that it applies to an individual diagnosis.
- Phase
- PHASE3
- Status at capture
- COMPLETED
- Registry last update
- 2023-06-02
This is a Phase 3, multicenter, randomized, double-blind, placebo-controlled study of niraparib as maintenance in platinum sensitive ovarian cancer patients who have either gBRCAmut or a tumor with high-grade serous histology and who have responded to their most recent chemotherapy containing a platinum agent. Niraparib is an orally active PARP inhibitor. Niraparib or placebo (in a 2:1 ratio) will be administered once daily continuously during a 28-day cycle. Health-related quality of life will be measured by the Functional Assessment of Cancer Therapy - Ovarian Symptom Index (FOSI), European Quality of Life scale, 5-Dimensions (EQ-5D), and a neuropathy questionnaire. Safety and tolerability will be assessed by clinical review of adverse events (AEs), physical examinations, electrocardiograms (ECGs), and safety laboratory values. The primary objective of this study is to evaluate efficacy of niraparib as maintenance therapy in patients who have platinum sensitive ovarian cancer as assessed by the prolongation of progression free survival (PFS).
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What did the study report?
Outcomes, safety and baseline populations are separate source sections. Quality-of-life measures appear under their original outcome titles.
Participant flow
Baseline characteristics
Progression-Free Survival (PFS) in Cohort With Germline BReast CAncer Gene (BRCA) Mutation (gBRCA)
Progression-Free Survival (PFS) in Cohort With No Germline BCRA With Homologous Recombination Deficiency-positive (HRD+) Tumors (Non-gBRCAmut HRD+)
Progression-Free Survival (PFS) in Cohort With No Germline BRCA Mutation
Time to First Subsequent Therapy in Cohort With Germline BRCA Mutation (gBRCA)
Time to First Subsequent Therapy in Cohort With No Germline BRCA Mutation
Chemotherapy-Free Interval in Cohort With Germline BRCA Mutation (gBRCA)
Chemotherapy-Free Interval in Cohort With No Germline BRCA Mutation
Progression-Free Survival 2 in Cohort With Germline BRCA Mutation (gBRCA)
Progression-Free Survival 2 in Cohort With No Germline BRCA Mutation
Overall Survival in Cohort With Germline BRCA Mutation (gBRCA)
Overall Survival in Cohort With No Germline BRCA Mutation
Time to Second Subsequent Therapy in Cohort With Germline BRCA Mutation (gBRCA)
Time to Second Subsequent Therapy in Cohort With No Germline BRCA Mutation
Change From Baseline in Functional Assessment of Cancer Therapy-Ovarian Symptom Index in Cohort With Germline BRCA at Cycle 2
Change From Baseline in Functional Assessment of Cancer Therapy-Ovarian Symptom Index in Cohort With Germline BRCA at Cycle 4
Change From Baseline in Functional Assessment of Cancer Therapy-Ovarian Symptom Index in Cohort With Germline BRCA at Cycle 6
Change From Baseline in Functional Assessment of Cancer Therapy-Ovarian Symptom Index in Cohort With Germline BRCA at Post-progression
Change From Baseline in Functional Assessment of Cancer Therapy-Ovarian Symptom Index in Cohort With no Germline BRCA at Cycle 2
Change From Baseline in Functional Assessment of Cancer Therapy-Ovarian Symptom Index in Cohort With no Germline BRCA at Cycle 4
Change From Baseline in Functional Assessment of Cancer Therapy-Ovarian Symptom Index in Cohort With no Germline BRCA at Cycle 6
Change From Baseline in Functional Assessment of Cancer Therapy-Ovarian Symptom Index in Cohort With no Germline BRCA at Post-progression
Change From Baseline in European Quality of Life Scale, 5-Dimensions (EQ-5D-5L) in Cohort With Germline BRCA at Cycle 2
Change From Baseline in EQ-5D-5L in Cohort With Germline BRCA at Cycle 4
Change From Baseline in EQ-5D-5L in Cohort With Germline BRCA at Cycle 6
Change From Baseline in EQ-5D-5L in Cohort With Germline BRCA at Post-progression
Change From Baseline in EQ-5D-5L in Cohort With no Germline BRCA at Cycle 2
Change From Baseline in EQ-5D-5L in Cohort With no Germline BRCA at Cycle 4
Change From Baseline in EQ-5D-5L in Cohort With no Germline BRCA at Cycle 6
Change From Baseline in EQ-5D-5L in Cohort With no Germline BRCA at Post-progression
Number of Participants With Response to Neuropathy Questionnaire in Cohort With Germline BRCA at Baseline
Number of Participants With Response to Neuropathy Questionnaire in Cohort With Germline BRCA at Cycle 2
Number of Participants With Response to Neuropathy Questionnaire in Cohort With Germline BRCA at Cycle 4
Number of Participants With Response to Neuropathy Questionnaire in Cohort With Germline BRCA at Cycle 6
Number of Participants With Response to Neuropathy Questionnaire in Cohort With Germline BRCA at Post-progression
Number of Participants With Response to Neuropathy Questionnaire in Cohort With no Germline BRCA at Baseline
Number of Participants With Response to Neuropathy Questionnaire in Cohort With no Germline BRCA at Cycle 2
Number of Participants With Response to Neuropathy Questionnaire in Cohort With no Germline BRCA at Cycle 4
Number of Participants With Response to Neuropathy Questionnaire in Cohort With no Germline BRCA at Cycle 6
Number of Participants With Response to Neuropathy Questionnaire in Cohort With no Germline BRCA at Post-progression
Number of Participants With Concordance of a Candidate Companion BRAC Analysis Diagnostic Test Compared to the Centralized BRCA Mutation Test Used in This Study
Number of Participants With Concordance of a Candidate Companion HRD Diagnostic Test Compared to the HRD Test Used in This Study
Number of Participants With Non-serious Adverse Events (AEs) and Serious AEs (SAEs)
Number of Participants With Non-serious AEs and SAEs (Post-study Unblinding)
Number of Participants With Non-serious AEs and SAEs in FE Sub-study
Number of Participants With Non-serious AEs and SAEs in QTc Sub-study
Area Under the Plasma Concentration-time Curve From Time 0 Extrapolated to Infinity (AUC[0-infinity]) Following Administration of Niraparib (FE Sub-study)
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)
Maximum Observed Plasma Concentration (Cmax) Following Administration of Niraparib (FE Sub-study)
Time to Reach Maximum (Tmax) Following Administration of Niraparib (FE Sub-study)
Terminal Elimination Half-life (t1/2) Following Administration of Niraparib (FE Sub-study)
Number of Participants With Maximum Post-Baseline QT Interval Corrected by Fridericia's Formula (QTcF) Greater Than Pre-specified Thresholds
Adverse events
Limitations, agreements, and source contact
Who could take part
- eligibility Criteria
- Inclusion Criteria: * 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 Exclusion Criteria: * 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
- healthy Volunteers
- false
- minimum Age
- 18 Years
- sex
- FEMALE
- std Ages
- ADULT
- OLDER_ADULT
Treatment arms and interventions
- arm Groups
- description
- 2:1 Ratio administered once daily continuously during a 28 day cycle.
- intervention Names
- Drug: Active comparator: Niraparib
- label
- Niraparib
- type
- ACTIVE_COMPARATOR
- description
- Administered once daily continuously over a 28 day cycle.
- intervention Names
- Drug: placebo
- label
- Placebo
- type
- PLACEBO_COMPARATOR
- interventions
- arm Group Labels
- Niraparib
- description
- Niraparib vs placebo 2:1 ratio
- name
- Active comparator: Niraparib
- other Names
- Niraparib
- type
- DRUG
- arm Group Labels
- Placebo
- name
- placebo
- type
- DRUG
Study design
- allocation
- RANDOMIZED
- intervention Model
- PARALLEL
- masking Info
- masking
- QUADRUPLE
- who Masked
- PARTICIPANT
- CARE_PROVIDER
- INVESTIGATOR
- OUTCOMES_ASSESSOR
- primary Purpose
- TREATMENT
Enrollment
- count
- 596
- type
- ACTUAL
Registered outcome plans (not posted results)
- primary Outcomes
- description
- PFS was defined as the time between randomization and disease progression or death from any cause. Computed tomography or magnetic resonance imaging to assess disease progression was performed at baseline, every 8 weeks through cycle 14, and then every 12 weeks until treatment discontinuation. The objective assessment of disease progression was determined by means of central radiologic and clinical review, according to Response Evaluation Criteria in Solid Tumors (RECIST),version 1.1, which was performed in a blinded fashion. PD is defined as at least a 20% increase in the sum of the diameters of target lesions, taking as reference the smallest sum on study.
- measure
- Progression-Free Survival (PFS) in Cohort With Germline BReast CAncer Gene (BRCA) Mutation (gBRCA)
- time Frame
- 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
- description
- PFS was defined as the time between randomization and disease progression or death from any cause. Computed tomography or magnetic resonance imaging to assess disease progression was performed at baseline, every 8 weeks through cycle 14, and then every 12 weeks until treatment discontinuation. The objective assessment of disease progression was determined by means of central radiologic and clinical review, according to Response Evaluation Criteria in Solid Tumors (RECIST),version 1.1, which was performed in a blinded fashion. PD was defined as at least a 20% increase in the sum of the diameters of target lesions, taking as reference the smallest sum on study. PD is defined as at least a 20% increase in the sum of the diameters of target lesions, taking as reference the smallest sum on study.
- measure
- Progression-Free Survival (PFS) in Cohort With No Germline BCRA With Homologous Recombination Deficiency-positive (HRD+) Tumors (Non-gBRCAmut HRD+)
- time Frame
- 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
- description
- PFS was defined as the time between randomization and disease progression or death from any cause. Computed tomography or magnetic resonance imaging to assess disease progression was performed at baseline, every 8 weeks through cycle 14, and then every 12 weeks until treatment discontinuation. The objective assessment of disease progression was determined by means of central radiologic and clinical review, according to Response Evaluation Criteria in Solid Tumors (RECIST),version 1.1, which was performed in a blinded fashion.PD is defined as at least a 20% increase in the sum of the diameters of target lesions, taking as reference the smallest sum on study.
- measure
- Progression-Free Survival (PFS) in Cohort With No Germline BRCA Mutation
- time Frame
- 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
- secondary Outcomes
- description
- The TFST was defined as the time from the date of randomization to the start date of the first subsequent anti-cancer therapy or death.
- measure
- Time to First Subsequent Therapy in Cohort With Germline BRCA Mutation (gBRCA)
- time Frame
- From date of randomization to the earliest date of first subsequent therapy or death, up to 7 years, 7 months and 4 days
- description
- The TFST was defined as the time from the date of randomization to the start date of the first subsequent anti-cancer therapy or death
- measure
- Time to First Subsequent Therapy in Cohort With No Germline BRCA Mutation
- time Frame
- From date of randomization to the earliest date of first subsequent therapy or death, up to 7 years, 7 months and 4 days
- description
- Chemotherapy-Free Interval was defined as the time from the last platinum therapy prior to randomization to the initiation of the next anti-cancer therapy after maintenance treatment
- measure
- Chemotherapy-Free Interval in Cohort With Germline BRCA Mutation (gBRCA)
- time Frame
- 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
- description
- Chemotherapy-Free Interval was defined as the time from the last platinum therapy prior to randomization to the initiation of the next anti-cancer therapy after maintenance treatment
- measure
- Chemotherapy-Free Interval in Cohort With No Germline BRCA Mutation
- time Frame
- 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
- description
- Progression-Free Survival 2 was defined as the date of randomization in the current study to the earlier date of assessment of progression on the next anti-cancer therapy following study treatment or death due to any cause. Progression was determined by the investigator via clinical and radiographic assessment using the same criteria as used in the current study.
- measure
- Progression-Free Survival 2 in Cohort With Germline BRCA Mutation (gBRCA)
- time Frame
- 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
- description
- Progression-Free Survival 2 was defined as the date of randomization in the current study to the earlier date of assessment of progression on the next anti-cancer therapy following study treatment or death due to any cause. Progression was determined by the investigator via clinical and radiographic assessment using the same criteria as used in the current study.
- measure
- Progression-Free Survival 2 in Cohort With No Germline BRCA Mutation
- time Frame
- 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
- description
- Overall survival was defined as the date of randomization to the date of death by any cause.
- measure
- Overall Survival in Cohort With Germline BRCA Mutation (gBRCA)
- time Frame
- From treatment randomization to date of death by any cause, up to 7 years, 7 months and 4 days
- description
- Overall survival was defined as the date of randomization to the date of death by any cause.
- measure
- Overall Survival in Cohort With No Germline BRCA Mutation
- time Frame
- From treatment randomization to date of death by any cause, up to 7 years, 7 months and 4 days
- description
- TSST was defined as the date of randomization to the earlier of the start date of second follow-up anti-cancer treatment or death.
- measure
- Time to Second Subsequent Therapy in Cohort With Germline BRCA Mutation (gBRCA)
- time Frame
- 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
- description
- TSST was defined as the date of randomization to the earlier of the start date of second follow-up anti-cancer treatment or death.
- measure
- Time to Second Subsequent Therapy in Cohort With No Germline BRCA Mutation
- time Frame
- 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
- description
- Functional Assessment of Cancer Therapy-Ovarian Symptom Index is a validated, 8-item measure of symptom response to treatment for ovarian cancer. Participants respond to their symptom experience over the past 7 days using a 5-point Likert scale score from "not at all" (0) to "very much" (4). The total score was calculated by multiplying the sum of all items scored by 8 and dividing the result by the number of responses. The total symptom index was calculated as the total of the 8 scores, ranging from 0 ("severely symptomatic") to 32 ("asymptomatic"). A positive change from Baseline indicates improvement. Baseline was latest non-missing pre-dose assessment on or before randomization date. Change from Baseline was calculated by subtracting the Baseline value from the post-dose visit value.
- measure
- Change From Baseline in Functional Assessment of Cancer Therapy-Ovarian Symptom Index in Cohort With Germline BRCA at Cycle 2
- time Frame
- Baseline (pre-dose on Day 1) and at Cycle 2 (Each cycle was of 28 days)
- description
- Functional Assessment of Cancer Therapy-Ovarian Symptom Index is a validated, 8-item measure of symptom response to treatment for ovarian cancer. Participants respond to their symptom experience over the past 7 days using a 5-point Likert scale score from "not at all" (0) to "very much" (4). The total score was calculated by multiplying the sum of all items scored by 8 and dividing the result by the number of responses. The total symptom index was calculated as the total of the 8 scores, ranging from 0 ("severely symptomatic") to 32 ("asymptomatic"). A positive change from Baseline indicates improvement. Baseline was latest non-missing pre-dose assessment on or before randomization date. Change from Baseline was calculated by subtracting the Baseline value from the post-dose visit value.
- measure
- Change From Baseline in Functional Assessment of Cancer Therapy-Ovarian Symptom Index in Cohort With Germline BRCA at Cycle 4
- time Frame
- Baseline (Pre-dose on Day 1) and at Cycle 4 (Each cycle was of 28 days)
Full study description
- brief Summary
- This is a Phase 3, multicenter, randomized, double-blind, placebo-controlled study of niraparib as maintenance in platinum sensitive ovarian cancer patients who have either gBRCAmut or a tumor with high-grade serous histology and who have responded to their most recent chemotherapy containing a platinum agent. Niraparib is an orally active PARP inhibitor. Niraparib or placebo (in a 2:1 ratio) will be administered once daily continuously during a 28-day cycle. Health-related quality of life will be measured by the Functional Assessment of Cancer Therapy - Ovarian Symptom Index (FOSI), European Quality of Life scale, 5-Dimensions (EQ-5D), and a neuropathy questionnaire. Safety and tolerability will be assessed by clinical review of adverse events (AEs), physical examinations, electrocardiograms (ECGs), and safety laboratory values. The primary objective of this study is to evaluate efficacy of niraparib as maintenance therapy in patients who have platinum sensitive ovarian cancer as assessed by the prolongation of progression free survival (PFS).
Source references
- references
- citation
- Mirza MR, Monk BJ, Herrstedt J, Oza AM, Mahner S, Redondo A, Fabbro M, Ledermann JA, Lorusso D, Vergote I, Ben-Baruch NE, Marth C, Madry R, Christensen RD, Berek JS, Dorum A, Tinker AV, du Bois A, Gonzalez-Martin A, Follana P, Benigno B, Rosenberg P, Gilbert L, Rimel BJ, Buscema J, Balser JP, Agarwal S, Matulonis UA; ENGOT-OV16/NOVA Investigators. Niraparib Maintenance Therapy in Platinum-Sensitive, Recurrent Ovarian Cancer. N Engl J Med. 2016 Dec 1;375(22):2154-2164. doi: 10.1056/NEJMoa1611310. Epub 2016 Oct 7.
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- 30026000
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- DERIVED
- citation
- Berek JS, Matulonis UA, Peen U, Ghatage P, Mahner S, Redondo A, Lesoin A, Colombo N, Vergote I, Rosengarten O, Ledermann J, Pineda M, Ellard S, Sehouli J, Gonzalez-Martin A, Berton-Rigaud D, Madry R, Reinthaller A, Hazard S, Guo W, Mirza MR. Safety and dose modification for patients receiving niraparib. Ann Oncol. 2018 Aug 1;29(8):1784-1792. doi: 10.1093/annonc/mdy181.
- pmid
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- DERIVED
- see Also Links
- label
- Facing our risk of cancer empowered website
Source notices and limitations
Discovery and provenance
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- nausea (in 11 patients vs. 2 on the placebo), and vomiting (in 7 patients vs. 1 on the placebo). </li><li>A subsequent analysis of the <a href="/clinicaltrials/NCT01847274">ENGOT-OV16/NOVA</a> trial (NCT01847274) updates PFS after maintenance niraparib or placebo according to the best response (partial response [PR] or complete r
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- mologous recombination deficiency–positive advanced ovarian cancer following response to front-line platinum-based chemotherapy (<a href="/clinicaltrials/NCT01847274">NCT01847274</a>) is closed to patient accrual and results are pending.</li><li>Other PARP inhibitor trials have been exploring their role in platinum-resistan
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- mbination deficiency–positive advanced ovarian cancer following response to front-line platinum-based chemotherapy (<a href="/clinicaltrials/NCT01847274">NCT01847274</a>) is closed to patient accrual and results are pending.</li><li>Other PARP inhibitor trials have been exploring their role in platinum-resistant disease and
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Preserved source evidence · Not medical advice