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CompletedNCT02354586QUADRAUpdated Sep 15, 2022Results posted

A Study of Niraparib in Patients With Ovarian Cancer Who Have Received Three or Four Previous Chemotherapy Regimens

A Phase 2 interventional study of Niraparib in Ovarian Neoplasms and Ovarian Cancer, sponsored by Tesaro, Inc.. Completed at 55 sites in 2 countries. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2022-09-15.

Sponsored by Tesaro, Inc. · Phase 2, Interventional, and Treatment

Phase
Phase 2
Study type
Interventional
Enrollment
463
Allocation
Not applicable
Ages
18 Years and older
Sex
Female
01

Study summary

This is a Phase 2, open-label, single arm study to evaluate the safety and efficacy of niraparib in ovarian cancer patients who have received three or four previous chemotherapy regimens. Niraparib is an orally active PARP inhibitor. Niraparib will be administered once daily continuously during a 28-day cycle. Health-related quality of life will be measured by Eastern Cooperative Oncology Group performance status (ECOG). Safety and tolerability will be assessed by clinical review of adverse events (AEs), physical examinations, electrocardiograms (ECGs), RECIST tumor assessments and safety laboratory values.

02

Conditions studied

  • Ovarian Neoplasms
  • Ovarian Cancer

Keywords

  • gBRCAmut
  • BRCA
  • PARP inhibitor
  • HRD
  • Ovarian cancer
  • Serous Epithelial
  • Fallopian Tube
  • Primary Peritoneal
03

In context

Ovarian Neoplasms

2,695 studies on the registry are indexed under Ovarian Neoplasms; 727 are open to participants now.

This study's enrollment of 463 is above the median of 60 across 2,030 interventional studies indexed under Ovarian Neoplasms.

Browse Ovarian Neoplasms studies →

Lead sponsor

Tesaro, Inc. is the lead sponsor of 32 studies on the registry; none are open to participants now.

Of its 12 completed or terminated interventional studies of FDA-regulated products, 12 (100%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
Female
Accepts healthy volunteers
No

Inclusion criteria

  • Patients must agree to undergo tumor HRD testing and blood gBRCAmut status testing.
  • Patients of childbearing potential must have negative pregnancy serum test within 72 hours of being dosed
  • Patients must have histologically diagnosed high-grade (Grade 2 or 3) serous epithelial ovarian, fallopian tube, or primary peritoneal cancer with recurrent disease and must have been previously treated with chemotherapy and experienced a response lasting at least 6 months to first-line platinum based therapy.
  • Patients Must have completed 3 or 4 previous chemotherapy regimens.
  • Patients must have completed their last chemotherapy regimen > 4 weeks prior to treatment initiation.
  • Patients must have measurable disease according to RECIST (v.1.1).
  • Patients must have formalin-fixed, paraffin-embedded tumor samples available from the primary or recurrent cancer or agree to undergo fresh biopsy prior to study treatment initiation.
  • Patients must agree to blood samples during screening and at the end of treatment for cytogenetic analysis.

Exclusion criteria

Exclusion Criteria:

  • Patients must not have any known, persistent (> 4 weeks), ≥Grade 3 hematologic toxicity during the last cancer therapy. Patients must not have any known, persistent (>4 weeks), ≥ Grade 3 fatigue during the last cancer therapy.
  • Patients must not have received pelvic radiotherapy as treatment for primary or recurrent disease within 1 year of the first dose of study treatment.
  • Patients must not have symptomatic uncontrolled brain or leptomeningeal metastases.
  • Patients must not be considered a poor medical risk due to a serious, uncontrolled medical disorder, nonmalignant systemic disease or active, uncontrolled infection.
  • Patients must not have received a transfusion (platelets or red blood cells) within 4 weeks of the first dose of study treatment.
  • Patients must not have known history or current diagnosis of myelodysplastic syndrome (MDS) or acute myeloid leukemia (AML).
05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
463 participants (actual)

Study arms

  • Experimental
    Niraparib

    Drug: Niraparib

Interventions

  • DrugNiraparib
06

What researchers measure

Primary outcomes

  1. Objective Response Rate (ORR)

    The ORR was defined as the percentage of participants achieving complete response (CR) or partial response (PR) as assessed by the Investigator per Response Evaluation Criteria in Solid Tumors (RECIST) (version1.1), where CR=Disappearance of all target lesions. Any pathological lymph nodes must be \<10 millimeters (mm) in the short axis, PR=At least a 30 percent (%) decrease in the sum of the diameters of target lesions, taking as a reference, the Baseline sum of the diameters. Primary Analysis Population comprised of participants who received 3 or 4 prior lines of therapy (LOT), had homologous recombination deficiency positive (HRDpos) tumors, had platinum-sensitive disease, and were poly(adenosine 5'-diphosphate \[ADP\]-ribose) polymerase inhibitors (PARPi) naïve.

    Time frame: Up to 3 years

Secondary outcomes

  1. Duration of Response (DoR)

    DoR was defined as the time from first documentation of CR or PR until the time of first documentation of disease progression (PD) as assessed by the Investigator per RECIST (version1.1). DoR was analyzed using Kaplan-Meier (KM) method.

    Time frame: Up to 3 years

  2. ORR by HRD Status and Breast Cancer Gene (BRCA) Status

    The ORR was defined as the percentage of participants achieving CR or PR as assessed by the Investigator per RECIST (version1.1), where CR=Disappearance of all target lesions. Any pathological lymph nodes must be \<10 mm in the short axis. PR=At least a 30% decrease in the sum of the diameters of target lesions, taking as a reference, the Baseline sum of the diameters. ORR was evaluated for participants with following characteristics: HRD status (positive, negative and unknown) and BRCA status (mutation positive, wild-type and unknown).

    Time frame: Up to 3 years

  3. Disease Control Rate (DCR)

    Disease control rate was defined as the percentage of participants achieving CR, PR, or stable disease (SD) as assessed by the Investigator per RECIST (version1.1). The exact (Clopper-Pearson) method was used to calculate 95% confidence interval.

    Time frame: Up to 3 years

  4. Progression Free Survival

    Progression-free survival was defined as the time from the date of first dose to the earlier date of assessment of progression or death by any cause in the absence of progression as assessed by the Investigator per RECIST (version 1.1) or clinical criteria. Progression is defined using RECIST version1.1 as at least a 20% increase in the sum of the diameter of target lesions or unequivocal progression of existing non-target lesions or the appearance of one or more new lesions.

    Time frame: Up to 3 years

  5. Overall Survival

    Overall Survival was defined as the time from the date of the first dose to the date of death by any cause. It was calculated as (Date of Death minus First dose date plus 1) divided by 30.4375.

    Time frame: Up to 3 years

  6. Time to First Subsequent Therapy (TFST)

    Time to first subsequent therapy (TFST) was defined as the time from the date of first dose to the date of first subsequent therapy or death, whichever occurs first. It was calculated as (Earlier of \[First dose of first subsequent therapy or death\] minus First dose date plus 1) divided by 30.4375.

    Time frame: Up to 3 years

Other outcomes

  1. Number of Participants With Any Non-serious Adverse Event (Non-SAE) and Any Serious Adverse Event (SAE)

    An adverse event is any untoward medical occurrence that occurs in a participant or clinical investigation participant administered a pharmaceutical product, and which does not necessarily have to have a causal relationship with study treatment. Any untoward event resulting in death, life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, congenital anomaly or birth defect or any other situation according to medical or scientific judgment was categorized as SAE. Adverse events which were not serious were considered as Non-serious adverse events.

    Time frame: Up to a maximum of 71.56 months

  2. Number of Participants With Abnormality in Hematology Parameters

    Number of participants with abnormality in hematology parameters were planned to be analyzed.

    Time frame: Up to 3 years

  3. Number of Participants With Abnormality in Clinical Chemistry Parameters

    Number of participants with abnormality in clinical chemistry parameters were planned to be analyzed.

    Time frame: Up to 3 years

  4. Number of Participants With Abnormality in Vital Signs

    Number of participants with abnormality in vital signs were planned to be analyzed.

    Time frame: Up to 3 years

  5. Number of Participants With Abnormality in Physical Examination

    Number of participants with abnormality in physical examination were planned to be analyzed.

    Time frame: Up to 3 years

  6. Number of Participants Who Were Administered Concomitant Medications

    Number of participants who were administered concomitant medications were planned to be analyzed.

    Time frame: Up to 3 years

07

Results

Posted Apr 9, 2020

Participant flow

This was an open-label, single arm study to evaluate the safety and efficacy of niraparib in ovarian cancer participants who have received previous chemotherapy regimens.

Participant flow — Overall Study
MilestoneNiraparib 300 mg
Started463
Completed0
Not completed463
Withdrew: Death230
Withdrew: Withdrawal by subject59
Withdrew: Lost to follow-up11
Withdrew: Sponsor decision51
Withdrew: Site closure2
Withdrew: Intercurrent illness1
Withdrew: Protocol violation3
Withdrew: Physician decision13
Withdrew: Lack of efficacy86
Withdrew: Adverse event7

Outcome measures

PrimaryObjective Response Rate (ORR)

The ORR was defined as the percentage of participants achieving complete response (CR) or partial response (PR) as assessed by the Investigator per Response Evaluation Criteria in Solid Tumors (RECIST) (version1.1), where CR=Disappearance of all target lesions. Any pathological lymph nodes must be \<10 millimeters (mm) in the short axis, PR=At least a 30 percent (%) decrease in the sum of the diameters of target lesions, taking as a reference, the Baseline sum of the diameters. Primary Analysis Population comprised of participants who received 3 or 4 prior lines of therapy (LOT), had homologous recombination deficiency positive (HRDpos) tumors, had platinum-sensitive disease, and were poly(adenosine 5'-diphosphate \[ADP\]-ribose) polymerase inhibitors (PARPi) naïve.

Time frame:
Up to 3 years
Reported as:
Number · Percentage of participants
Objective Response Rate (ORR)
Percentage of participantsNiraparib 300 mg
Objective Response Rate (ORR)27.66 (15.6 to 42.6)
SecondaryDuration of Response (DoR)

DoR was defined as the time from first documentation of CR or PR until the time of first documentation of disease progression (PD) as assessed by the Investigator per RECIST (version1.1). DoR was analyzed using Kaplan-Meier (KM) method.

Time frame:
Up to 3 years
Reported as:
Median · Months
Duration of Response (DoR)
MonthsNiraparib 300 mg
Duration of Response (DoR)9.4 (6.6 to 18.3)
SecondaryORR by HRD Status and Breast Cancer Gene (BRCA) Status

The ORR was defined as the percentage of participants achieving CR or PR as assessed by the Investigator per RECIST (version1.1), where CR=Disappearance of all target lesions. Any pathological lymph nodes must be \<10 mm in the short axis. PR=At least a 30% decrease in the sum of the diameters of target lesions, taking as a reference, the Baseline sum of the diameters. ORR was evaluated for participants with following characteristics: HRD status (positive, negative and unknown) and BRCA status (mutation positive, wild-type and unknown).

Time frame:
Up to 3 years
Reported as:
Number · Percentage of participants
ORR by HRD Status and Breast Cancer Gene (BRCA) Status
Percentage of participantsNiraparib 300 mg
HRD positive, n=22114.0 (9.7 to 19.3)
HRD negative, n=1952.6 (0.8 to 5.9)
HRD unknown, n=456.7 (1.4 to 18.3)
BRCA mutation positive, n=8723.0 (14.6 to 33.2)
BRCA wild-type, n=3175.0 (2.9 to 8.1)
BRCA unknown, n=575.3 (1.1 to 14.6)
SecondaryDisease Control Rate (DCR)

Disease control rate was defined as the percentage of participants achieving CR, PR, or stable disease (SD) as assessed by the Investigator per RECIST (version1.1). The exact (Clopper-Pearson) method was used to calculate 95% confidence interval.

Time frame:
Up to 3 years
Reported as:
Number · Percentage of participants
Disease Control Rate (DCR)
Percentage of participantsNiraparib 300 mg
Disease Control Rate (DCR)49.02 (44.4 to 53.7)
SecondaryProgression Free Survival

Progression-free survival was defined as the time from the date of first dose to the earlier date of assessment of progression or death by any cause in the absence of progression as assessed by the Investigator per RECIST (version 1.1) or clinical criteria. Progression is defined using RECIST version1.1 as at least a 20% increase in the sum of the diameter of target lesions or unequivocal progression of existing non-target lesions or the appearance of one or more new lesions.

Time frame:
Up to 3 years
Reported as:
Median · Months
Progression Free Survival
MonthsNiraparib 300 mg
Progression Free Survival3.5 (3.2 to 3.7)
SecondaryOverall Survival

Overall Survival was defined as the time from the date of the first dose to the date of death by any cause. It was calculated as (Date of Death minus First dose date plus 1) divided by 30.4375.

Time frame:
Up to 3 years
Reported as:
Median · Months
Overall Survival
MonthsNiraparib 300 mg
Overall Survival17.2 (14.9 to 19.8)
SecondaryTime to First Subsequent Therapy (TFST)

Time to first subsequent therapy (TFST) was defined as the time from the date of first dose to the date of first subsequent therapy or death, whichever occurs first. It was calculated as (Earlier of \[First dose of first subsequent therapy or death\] minus First dose date plus 1) divided by 30.4375.

Time frame:
Up to 3 years
Reported as:
Median · Months
Time to First Subsequent Therapy (TFST)
MonthsNiraparib 300 mg
Time to First Subsequent Therapy (TFST)6.8 (5.9 to 7.5)
Other pre-specifiedNumber of Participants With Any Non-serious Adverse Event (Non-SAE) and Any Serious Adverse Event (SAE)

An adverse event is any untoward medical occurrence that occurs in a participant or clinical investigation participant administered a pharmaceutical product, and which does not necessarily have to have a causal relationship with study treatment. Any untoward event resulting in death, life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, congenital anomaly or birth defect or any other situation according to medical or scientific judgment was categorized as SAE. Adverse events which were not serious were considered as Non-serious adverse events.

Time frame:
Up to a maximum of 71.56 months
Reported as:
Count of participants · Participants
Number of Participants With Any Non-serious Adverse Event (Non-SAE) and Any Serious Adverse Event (SAE)
ParticipantsNiraparib 300 mg
Any non-SAE461
Any SAE200
Other pre-specifiedNumber of Participants With Abnormality in Hematology Parameters

Number of participants with abnormality in hematology parameters were planned to be analyzed.

Time frame:
Up to 3 years

No measurements were reported for this outcome.

Other pre-specifiedNumber of Participants With Abnormality in Clinical Chemistry Parameters

Number of participants with abnormality in clinical chemistry parameters were planned to be analyzed.

Time frame:
Up to 3 years

No measurements were reported for this outcome.

Other pre-specifiedNumber of Participants With Abnormality in Vital Signs

Number of participants with abnormality in vital signs were planned to be analyzed.

Time frame:
Up to 3 years

No measurements were reported for this outcome.

Other pre-specifiedNumber of Participants With Abnormality in Physical Examination

Number of participants with abnormality in physical examination were planned to be analyzed.

Time frame:
Up to 3 years

No measurements were reported for this outcome.

Other pre-specifiedNumber of Participants Who Were Administered Concomitant Medications

Number of participants who were administered concomitant medications were planned to be analyzed.

Time frame:
Up to 3 years

No measurements were reported for this outcome.

Adverse events

Collected over All-cause mortality, Non-serious adverse events (Non-SAEs) and Serious adverse events (SAEs) were reported up to a maximum of 71.56 months. Non-serious events are listed at a 0% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Niraparib 300 mg232/463 (50.1%)200/463 (43.2%)461/463 (99.6%)
Most frequent serious events
Showing 10 of 124
Most frequent serious events
EventNiraparib 300 mg
ThrombocytopeniaBlood and lymphatic system disorders34/463
Small intestinal obstructionGastrointestinal disorders34/463
VomitingGastrointestinal disorders27/463
NauseaGastrointestinal disorders21/463
Abdominal painGastrointestinal disorders17/463
AnaemiaBlood and lymphatic system disorders15/463
NeutropeniaBlood and lymphatic system disorders11/463
ConstipationGastrointestinal disorders10/463
Intestinal obstructionGastrointestinal disorders8/463
SepsisInfections and infestations8/463
Most frequent other events
Showing 10 of 528
Most frequent other events
EventNiraparib 300 mg
NauseaGastrointestinal disorders310/463
FatigueGeneral disorders244/463
AnaemiaBlood and lymphatic system disorders233/463
VomitingGastrointestinal disorders202/463
ConstipationGastrointestinal disorders161/463
ThrombocytopeniaBlood and lymphatic system disorders151/463
Decreased appetiteMetabolism and nutrition disorders127/463
InsomniaPsychiatric disorders105/463
Platelet count decreasedInvestigations101/463
HypomagnesaemiaMetabolism and nutrition disorders91/463

Baseline characteristics

Baseline characteristics were reported for Safety Population.

Age, Continuous
Age, Continuous(Years)Niraparib 300 mg
Mean64.3 ± 9.28
Sex: Female, Male
Sex: Female, Male(Participants)Niraparib 300 mg
Female463
Male0
Race/Ethnicity, Customized
Race/Ethnicity, Customized(Participants)Niraparib 300 mg
White394
Black20
Asian16
American Indian or Alaska Native1
Unknown32
08

Study locations

55 sites
  • GSK Investigational Site
    Chandler, Arizona 85224, United States
  • GSK Investigational Site
    Phoenix, Arizona 85016, United States
  • GSK Investigational Site
    Tucson, Arizona 85710, United States
  • GSK Investigational Site
    Burbank, California 91505, United States
  • GSK Investigational Site
    Duarte, California 91010, United States
  • GSK Investigational Site
    Los Angeles, California 90027, United States
  • GSK Investigational Site
    Los Angeles, California 90048, United States
  • GSK Investigational Site
    San Francisco, California 94118, United States
  • GSK Investigational Site
    Santa Barbara, California 93105, United States
  • GSK Investigational Site
    Stanford, California 94305-5317, United States
  • GSK Investigational Site
    New Haven, Connecticut 06510, United States
  • GSK Investigational Site
    Tampa, Florida 33612, United States
  • GSK Investigational Site
    West Palm Beach, Florida 33401, United States
  • GSK Investigational Site
    Atlanta, Georgia 30342, United States
  • GSK Investigational Site
    Chicago, Illinois 60611, United States
  • GSK Investigational Site
    Chicago, Illinois 60637, United States
  • GSK Investigational Site
    Indianapolis, Indiana 46260, United States
  • GSK Investigational Site
    Indianapolis, Indiana 54244, United States
  • GSK Investigational Site
    Covington, Louisiana 70433, United States
  • GSK Investigational Site
    New Orleans, Louisiana 70121, United States
  • GSK Investigational Site
    Baltimore, Maryland 21202, United States
  • GSK Investigational Site
    Boston, Massachusetts 02115, United States
  • GSK Investigational Site
    Boston, Massachusetts 02215, United States
  • GSK Investigational Site
    Burlington, Massachusetts 01805, United States
  • GSK Investigational Site
    Ann Arbor, Michigan 48109, United States
  • GSK Investigational Site
    Minneapolis, Minnesota 55455, United States
  • GSK Investigational Site
    Rochester, Minnesota 55905, United States
  • GSK Investigational Site
    Springfield, Missouri 65804, United States
  • GSK Investigational Site
    Hackensack, New Jersey 07601, United States
  • GSK Investigational Site
    Morristown, New Jersey 07962-1956, United States
  • GSK Investigational Site
    East Setauket, New York 11733, United States
  • GSK Investigational Site
    Jamaica, New York 11432, United States
  • GSK Investigational Site
    Lake Success, New York 11042, United States
  • GSK Investigational Site
    New York, New York 10065, United States
  • GSK Investigational Site
    Durham, North Carolina 27710, United States
  • GSK Investigational Site
    Oklahoma City, Oklahoma 73104, United States
  • GSK Investigational Site
    Medford, Oregon 97504-8342, United States
  • GSK Investigational Site
    Wynnewood, Pennsylvania 19096, United States
  • GSK Investigational Site
    Providence, Rhode Island 02905, United States
  • GSK Investigational Site
    Nashville, Tennessee 37203, United States
  • GSK Investigational Site
    Austin, Texas 78731, United States
  • GSK Investigational Site
    Dallas, Texas 75390, United States
  • GSK Investigational Site
    Fort Worth, Texas 76104, United States
  • GSK Investigational Site
    San Antonio, Texas 78229, United States
  • GSK Investigational Site
    The Woodlands, Texas 77380, United States
  • GSK Investigational Site
    Tyler, Texas 75702, United States
  • GSK Investigational Site
    Spokane, Washington 99202, United States
  • GSK Investigational Site
    Tacoma, Washington 98405, United States
  • GSK Investigational Site
    Calgary, Alberta T2N 4N2, Canada
  • GSK Investigational Site
    Toronto, Ontario M5G 2M9, Canada
  • GSK Investigational Site
    Montreal, Quebec H1T 2M4, Canada
  • GSK Investigational Site
    Montreal, Quebec H2L 4M1, Canada
  • GSK Investigational Site
    Montreal, Quebec H3T 1E2, Canada
  • GSK Investigational Site
    Montreal, Quebec H4A 3J1, Canada
  • GSK Investigational Site
    Sherbrooke, Quebec J1H 5N4, Canada
09

References and documents

Publications

  • Moore KN, Secord AA, Geller MA, Miller DS, Cloven N, Fleming GF, Wahner Hendrickson AE, Azodi M, DiSilvestro P, Oza AM, Cristea M, Berek JS, Chan JK, Rimel BJ, Matei DE, Li Y, Sun K, Luptakova K, Matulonis UA, Monk BJ. Niraparib monotherapy for late-line treatment of ovarian cancer (QUADRA): a multicentre, open-label, single-arm, phase 2 trial. Lancet Oncol. 2019 May;20(5):636-648. doi: 10.1016/S1470-2045(19)30029-4. Epub 2019 Apr 1. Erratum In: Lancet Oncol. 2019 May;20(5):e242. doi: 10.1016/S1470-2045(19)30242-6. PubMed 30948273 ↗

Study documents

  • Study protocol · Dec 21, 2017
  • Statistical analysis plan · Jul 21, 2021

Documents are hosted by the registry — open the source record to download them.

10

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 15, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT02354586
Lead sponsor
Tesaro, Inc.
Collaborators
Facing Our Risk of Cancer Empowered, Myriad Genetics, Inc.
Responsible party
Sponsor
First posted
Feb 3, 2015
Start date
Mar 23, 2015
Primary completion
Feb 28, 2018
Completion
Aug 23, 2021
Results posted
Apr 9, 2020
Last update
Sep 15, 2022

Study contacts

GSK Clinical Trials
study director · GlaxoSmithKline
View the source record on ClinicalTrials.gov ↗

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