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NCT02354586 · CITED IN SOURCE DOCUMENTS

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

An NCI or FDA source cites this study. A citation does not establish that it applies to an individual diagnosis.

Phase
PHASE2
Status at capture
COMPLETED
Registry last update
2022-09-15

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.

Open the original ClinicalTrials.gov record → · Download preserved record

What did the study report?

Outcomes, safety and baseline populations are separate source sections. Quality-of-life measures appear under their original outcome titles.

flow

Participant flow

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baseline

Baseline characteristics

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outcome · POSTED

Objective Response Rate (ORR)

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outcome · POSTED

Duration of Response (DoR)

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outcome · POSTED

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

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outcome · POSTED

Disease Control Rate (DCR)

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outcome · POSTED

Progression Free Survival

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outcome · POSTED

Overall Survival

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outcome · POSTED

Time to First Subsequent Therapy (TFST)

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outcome · POSTED

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

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outcome · POSTED

Number of Participants With Abnormality in Hematology Parameters

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outcome · POSTED

Number of Participants With Abnormality in Clinical Chemistry Parameters

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outcome · POSTED

Number of Participants With Abnormality in Vital Signs

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outcome · POSTED

Number of Participants With Abnormality in Physical Examination

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outcome · POSTED

Number of Participants Who Were Administered Concomitant Medications

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adverse events

Adverse events

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more info

Limitations, agreements, and source contact

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Who could take part
eligibility Criteria
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: * 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).
healthy Volunteers
false
minimum Age
18 Years
sex
FEMALE
std Ages
  1. ADULT
  2. OLDER_ADULT
Treatment arms and interventions
arm Groups
  1. intervention Names
    1. Drug: Niraparib
    label
    Niraparib
    type
    EXPERIMENTAL
interventions
  1. arm Group Labels
    1. Niraparib
    name
    Niraparib
    type
    DRUG
Study design
allocation
NA
intervention Model
SINGLE_GROUP
masking Info
masking
NONE
primary Purpose
TREATMENT
Enrollment
count
463
type
ACTUAL
Registered outcome plans (not posted results)
other Outcomes
  1. description
    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.
    measure
    Number of Participants With Any Non-serious Adverse Event (Non-SAE) and Any Serious Adverse Event (SAE)
    time Frame
    Up to a maximum of 71.56 months
  2. description
    Number of participants with abnormality in hematology parameters were planned to be analyzed.
    measure
    Number of Participants With Abnormality in Hematology Parameters
    time Frame
    Up to 3 years
  3. description
    Number of participants with abnormality in clinical chemistry parameters were planned to be analyzed.
    measure
    Number of Participants With Abnormality in Clinical Chemistry Parameters
    time Frame
    Up to 3 years
  4. description
    Number of participants with abnormality in vital signs were planned to be analyzed.
    measure
    Number of Participants With Abnormality in Vital Signs
    time Frame
    Up to 3 years
  5. description
    Number of participants with abnormality in physical examination were planned to be analyzed.
    measure
    Number of Participants With Abnormality in Physical Examination
    time Frame
    Up to 3 years
  6. description
    Number of participants who were administered concomitant medications were planned to be analyzed.
    measure
    Number of Participants Who Were Administered Concomitant Medications
    time Frame
    Up to 3 years
primary Outcomes
  1. description
    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.
    measure
    Objective Response Rate (ORR)
    time Frame
    Up to 3 years
secondary Outcomes
  1. description
    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.
    measure
    Duration of Response (DoR)
    time Frame
    Up to 3 years
  2. description
    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).
    measure
    ORR by HRD Status and Breast Cancer Gene (BRCA) Status
    time Frame
    Up to 3 years
  3. description
    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.
    measure
    Disease Control Rate (DCR)
    time Frame
    Up to 3 years
  4. description
    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.
    measure
    Progression Free Survival
    time Frame
    Up to 3 years
  5. description
    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.
    measure
    Overall Survival
    time Frame
    Up to 3 years
  6. description
    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.
    measure
    Time to First Subsequent Therapy (TFST)
    time Frame
    Up to 3 years
Full study description
brief 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.
Source references
references
  1. citation
    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.
    pmid
    30948273
    type
    BACKGROUND
  2. citation
    Monk BJ, Romero I, Graybill W, Churruca C, O'Malley DM, Knudsen AO, Yap OWS, Baurain JF, Rose PG, Denys H, Ghamande S, Pisano C, Fabbro M, Braicu EI, Calvert PM, Amit A, Prendergast E, Taylor A, Kheibarshekan L, Zhang ZY, Zajic S, Jewell RC, Gupta D, Gonzalez-Martin A. Niraparib Population Pharmacokinetics and Exposure-Response Relationships in Patients With Newly Diagnosed Advanced Ovarian Cancer. Clin Ther. 2024 Aug;46(8):612-621. doi: 10.1016/j.clinthera.2024.06.001. Epub 2024 Jul 16.
    pmid
    39019698
    type
    DERIVED
Source notices and limitations
    Discovery and provenance
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        ss="gene-name">BRCA</em>-altered cancer who had been treated with at least two previous lines of chemotherapy.</li></ul></div></li><li><a href="/clinicaltrials/NCT02354586">QUADRA</a> (NCT02354586) was a multicenter, open-label, single-arm phase II trial that studied niraparib as late-line treatment for patients with ovarian canc
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        altered cancer who had been treated with at least two previous lines of chemotherapy.</li></ul></div></li><li><a href="/clinicaltrials/NCT02354586">QUADRA</a> (NCT02354586) was a multicenter, open-label, single-arm phase II trial that studied niraparib as late-line treatment for patients with ovarian cancer.[<a href="#cit/section
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      source update dates
      1. context
        Updated: May 14, 2025
        datetime
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        display
        May 14, 2025

    Preserved source evidence · Not medical advice