Description:
This study is a double-blind, randomized, placebo-controlled (2:1 niraparib:placebo) study in
patients with Stage III or IV ovarian cancer. Patients must have completed front-line
platinum based regimen with a physician-assessed response of Complete Response (CR) or
Partial Response (PR). Additionally, patients must have a normal or >90% decrease in cancer
antigen 125 (CA-125) following front-line platinum treatment. The study will assess the
efficacy of niraparib as maintenance treatment, as measured by PFS.
Title
- Brief Title: A Study of Niraparib Maintenance Treatment in Patients With Advanced Ovarian Cancer Following Response on Front-Line Platinum-Based Chemotherapy
- Official Title: A Phase 3, Randomized, Double-Blind, Placebo-Controlled, Multicenter Study of Niraparib Maintenance Treatment in Patients With Advanced Ovarian Cancer Following Response on Front-Line Platinum-Based Chemotherapy
Clinical Trial IDs
- ORG STUDY ID:
213359
- SECONDARY ID:
PR-30-5017-C
- NCT ID:
NCT02655016
Conditions
- Ovarian Neoplasms
- Ovarian Cancer
Interventions
Drug | Synonyms | Arms |
---|
Niraparib | | Niraparib |
Placebo | | Placebo |
Purpose
This study is a double-blind, randomized, placebo-controlled (2:1 niraparib:placebo) study in
patients with Stage III or IV ovarian cancer. Patients must have completed front-line
platinum based regimen with a physician-assessed response of Complete Response (CR) or
Partial Response (PR). Additionally, patients must have a normal or >90% decrease in cancer
antigen 125 (CA-125) following front-line platinum treatment. The study will assess the
efficacy of niraparib as maintenance treatment, as measured by PFS.
Trial Arms
Name | Type | Description | Interventions |
---|
Niraparib | Experimental | Administered once daily continuously during a 28 day cycle. | |
Placebo | Placebo Comparator | Administered once daily continuously over a 28 day cycle | |
Eligibility Criteria
Main Inclusion Criteria:
- Patient must have histologically confirmed, advanced (FIGO Stage III or IV) high-grade
predominantly serous or endometrioid ovarian cancer, fallopian tube cancer, or primary
peritoneal cancer who have completed first line platinum based chemotherapy
(neoadjuvant or adjuvant)
- Patient must have clinical complete response or partial response following completion
of chemotherapy course.
- All Stage IV patients are eligible, irrespective of residual disease, after primary or
interval debulking. Stage III patients are required to have visible residual disease
after primary surgery. Patients with inoperable Stage III and IV disease are eligible
- Patient must agree to undergo central tumor HRD testing
- Patients of childbearing potential must have negative pregnancy serum test within 72
hours of being dosed
- Patient must be randomized within 12 weeks of the first day of the last cycle of
chemotherapy
Main Exclusion Criteria:
- Patient has mucinous or clear cell subtypes of epithelial ovarian cancer,
carcinosarcoma or undifferentiated ovarian cancer
- Patient has undergone more than 2 debulking surgeries
- Patient is to receive bevacizumab as maintenance treatment
- Patient is pregnant, breastfeeding, or expecting to conceive children, while receiving
study treatment and for 180 days after the last dose of study treatment
- Patient has had prior treatment with a known PARP inhibitor
- Patient has been diagnosed and/or treated for any invasive cancer (other than study
disease) less than 5 years prior to study enrollment.
Maximum Eligible Age: | N/A |
Minimum Eligible Age: | 18 Years |
Eligible Gender: | Female |
Healthy Volunteers: | No |
Primary Outcome Measures
Measure: | Progression Free Survival |
Time Frame: | Up to 34 months |
Safety Issue: | |
Description: | Progression free survival was defined as the time from the date of treatment randomization to the date of first documentation of disease progression or death due to any cause in the absence of documented progression, whichever occurs first. It was assessed by the blinded independent central review (BICR). Median and 95% confidence interval (CI) are presented. |
Secondary Outcome Measures
Measure: | Overall Survival |
Time Frame: | Up to 34 months |
Safety Issue: | |
Description: | Overall survival was defined as the time from the date of randomization to the date of death by any cause. Median and 95% CI are presented for overall survival interim analysis. |
Measure: | Time to First Subsequent Therapy (TFST) |
Time Frame: | Up to 34 months |
Safety Issue: | |
Description: | Time to first subsequent therapy was defined as the time from the date of randomization to the date of the first subsequent anti-cancer therapy or death, whichever occurs first. Median and 95% CI are presented. |
Measure: | Progression-Free Survival-2 (PFS2) |
Time Frame: | Up to 34 months |
Safety Issue: | |
Description: | PFS2 was defined as the time from the date of randomization to the date of progression on the next anti-cancer therapy following study treatment or death by any cause, whichever occurs first. Median and 95% CI are presented. |
Measure: | Change From Baseline in Participant Reported Outcome (PRO): Functional Assessment of Cancer Therapy-Ovarian Symptom Index (FOSI) |
Time Frame: | Baseline (Day 1, Pre-dose) and Up to Week 24 |
Safety Issue: | |
Description: | FOSI is a validated, 8-item measure of symptom response to treatment for ovarian cancer. Participants responded to their symptom experience over the past 7 days using a 5-point Likert scale scored from "not at all" (0) to "very much" (4). FOSI score was calculated as (sum of item scores)*8 divided by (number of items answered). The FOSI score ranged from 0 (severely symptomatic) to 32 (asymptomatic). A higher score indicated a better quality of life (QoL). Change from Baseline was calculated by subtracting Baseline value from the post-dose visit value. Baseline was defined as the latest pre-dose assessment (Day 1 pre-dose). |
Measure: | Change From Baseline in PRO: European Quality of Life Scale, 5-dimensions, 5-levels of Severity (EQ-5D-5L) Utility Score |
Time Frame: | Baseline (Day 1, Pre-dose) and Up to Week 24 |
Safety Issue: | |
Description: | The EQ-5D-5L is a well-validated general preference-based, health-related QoL instrument. The five-item measure has 1 question assessing each of 5 dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression and 5 levels for each dimension including 1=no problems, 2=slight problems, 3=moderate problems, 4=severe problems and 5=extreme problems. The health state is defined by combining the levels of answers from each of the 5 questions. Each health state is referred to in terms of a 5 digit code. Health state 5 digit code is translated into utility score, which is valued up to 1 (perfect health) with lower values meaning worse state. EQ-5D-5L utility score ranges from -0.281 to 1. Higher scores indicate better health. Change from Baseline was calculated by subtracting Baseline value from the post-dose visit value. Baseline was defined as the latest pre-dose assessment (Day 1 pre-dose). |
Measure: | Change From Baseline in Functional Scales of European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30) |
Time Frame: | Baseline (Day 1, Pre-dose) and Up to Week 24 |
Safety Issue: | |
Description: | EORTC-QLQ-C30 incorporates 5 functional scales (physical, role, cognitive, emotional, and social), 3 symptom scales (fatigue, pain, and nausea/vomiting), a global health status/QoL scale (global health status, QoL), and 6 single items (dyspnea, appetite loss, insomnia, constipation, diarrhea, and financial difficulty) assessing additional symptoms commonly reported by participants with cancer. Five functional scales had total 15 items (physical-5, role-2, cognitive-4, emotional-2, and social-2). Each functional scales score was calculated by averaging scores of all scale items and transforming average scores linearly (1 minus [average score minus 1] divided by 3*100). All of the functional scales range in score from 0 to 100. Higher score represents a higher ("better") level of functioning. Change from Baseline was calculated by subtracting Baseline value from the post-dose visit value. Baseline was defined as the latest pre-dose assessment (Day 1 pre-dose). |
Measure: | Change From Baseline in Global Health Status/QoL of EORTC-QLQ-C30 |
Time Frame: | Baseline (Day 1, Pre-dose) and Up to Week 24 |
Safety Issue: | |
Description: | EORTC-QLQ-C30 incorporates 5 functional scales (physical, role, cognitive, emotional, and social), 3 symptom scales (fatigue, pain, and nausea/vomiting), a global health status/QoL scale (global health status, QoL), and 6 single items (dyspnea, appetite loss, insomnia, constipation, diarrhea, and financial difficulty) assessing additional symptoms commonly reported by participants with cancer. A global health status/QoL scale had total 2 items. Each global health status/QoL scales score was calculated by averaging scores of all scale items and transforming average scores linearly ([average score minus 1] divided by 6*100). The global health status/QoL scales range in score from 0 to 100. Higher score represents a higher ("better") level of health status/QoL. Change from Baseline was calculated by subtracting Baseline value from the post-dose visit value. Baseline was defined as the latest pre-dose assessment (Day 1 pre-dose). |
Measure: | Change From Baseline in Symptoms Scales and Symptoms Items (Dyspnea, Appetite Loss, Insomnia, Constipation, Diarrhea and Financial Difficulty) of EORTC-QLQ-C30 |
Time Frame: | Baseline (Day 1, Pre-dose) and Up to Week 24 |
Safety Issue: | |
Description: | EORTC-QLQ-C30 incorporates 5 functional scales (physical, role, cognitive, emotional, and social), 3 symptom scales (fatigue, pain, and nausea/vomiting), a global health status/QoL scale, and 6 single items (dyspnea, appetite loss, insomnia, constipation, diarrhea, and financial difficulty) assessing additional symptoms commonly reported by participants with cancer. Symptom scale had total 7 items (fatigue-3, pain-2, nausea/vomiting-2). Each symptoms scales and 6 single additional symptoms items score was calculated by averaging scores of all scale items and transforming average scores linearly ([average score minus 1] divided by 3*100). All of the symptoms scales and 6 single additional symptoms scales range in score from 0 to 100. Higher score represents a higher ("worse") level of symptoms. Change from Baseline was calculated by subtracting Baseline value from the post-dose visit value. Baseline was defined as the latest pre-dose assessment (Day 1 pre-dose). |
Measure: | Change From Baseline in Functional Scales of European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Ovarian Cancer Module (EORTC-QLQ-OV28) |
Time Frame: | Baseline (Day 1, Pre-dose) and Up to 34 months |
Safety Issue: | |
Description: | EORTC-QLQ-OV28 is supplement to EORTC-QLQ-C30. It includes 3 functional scales (body image, sexuality, attitude to disease/treatment) and 5 symptom scales/items (abdominal/gastrointestinal [GI] symptoms, peripheral neuropathy, hormonal/menopausal symptoms, other chemotherapy side-effects, and hair loss). Functional scales score (body Image and attitude to disease/treatment) was calculated by averaging scores of all scale items and transforming average scores linearly (1 minus [average score minus 1] divided by 3*100). Functional scales score (sexuality) was calculated by averaging scores of all scale items and transforming average scores linearly ([average score minus 1] divided by 3*100). All of the functional scales range in score from 0 to 100. Higher score represents a higher ("better") level of functioning. Change from Baseline was calculated by subtracting Baseline value from the post-dose visit value. Baseline was defined as the latest pre-dose assessment (Day 1 pre-dose). |
Measure: | Change From Baseline in Symptoms Scale of EORTC-QLQ-OV28 |
Time Frame: | Baseline (Day 1, Pre-dose) and Up to 34 months |
Safety Issue: | |
Description: | EORTC-QLQ-OV28 is supplement to EORTC-QLQ-C30. It includes 3 functional scales (body image, sexuality, attitude to disease/treatment) and 5 symptom scales/items (abdominal/GI symptoms, peripheral neuropathy, hormonal/menopausal symptoms, other chemotherapy side-effects, and hair loss). Symptoms scales score was calculated by averaging scores of all scale items and transforming average scores linearly ([average score minus 1] divided by 3*100). All of the symptoms scales range in score from 0 to 100. Higher score represents a higher ("worse") level of symptoms. Change from Baseline was calculated by subtracting Baseline value from the post-dose visit value. Baseline was defined as the latest pre-dose assessment (Day 1 pre-dose). |
Details
Phase: | Phase 3 |
Primary Purpose: | Interventional |
Overall Status: | Active, not recruiting |
Lead Sponsor: | Tesaro, Inc. |
Trial Keywords
- Ovarian Cancer
- PARP Inhibitor
- HRD
- HRD positive
- PRIMA
- PRIMA Clinical Trial
- PRIMA Study
Last Updated
June 28, 2021