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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02354586
Recruitment Status : Completed
First Posted : February 3, 2015
Results First Posted : April 9, 2020
Last Update Posted : September 15, 2022
Sponsor:
Collaborators:
Facing Our Risk of Cancer Empowered
Myriad Genetics, Inc.
Information provided by (Responsible Party):
Tesaro, Inc.

Study Description
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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.

Condition or disease Intervention/treatment Phase
Ovarian Neoplasms Ovarian Cancer Drug: Niraparib Phase 2

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 463 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase 2, Open-Label, Single-Arm Study to Evaluate the Safety and Efficacy of Niraparib in Patients With Advanced, Relapsed, High-Grade Serous Epithelial Ovarian, Fallopian Tube, or Primary Peritoneal Cancer Who Have Received Three or Four Previous Chemotherapy Regimens
Actual Study Start Date : March 23, 2015
Actual Primary Completion Date : February 28, 2018
Actual Study Completion Date : August 23, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Ovarian Cancer

Arms and Interventions
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Arm Intervention/treatment
Experimental: Niraparib Drug: Niraparib


Outcome Measures
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Primary Outcome Measures :
  1. Objective Response Rate (ORR) [ Time Frame: Up to 3 years ]
    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.


Secondary Outcome Measures :
  1. Duration of Response (DoR) [ Time Frame: Up to 3 years ]
    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.

  2. ORR by HRD Status and Breast Cancer Gene (BRCA) Status [ Time Frame: Up to 3 years ]
    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).

  3. Disease Control Rate (DCR) [ Time Frame: Up to 3 years ]
    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.

  4. Progression Free Survival [ Time Frame: Up to 3 years ]
    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.

  5. Overall Survival [ Time Frame: Up to 3 years ]
    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.

  6. Time to First Subsequent Therapy (TFST) [ Time Frame: Up to 3 years ]
    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.


Other Outcome Measures:
  1. 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 ]
    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.

  2. Number of Participants With Abnormality in Hematology Parameters [ Time Frame: Up to 3 years ]
    Number of participants with abnormality in hematology parameters were planned to be analyzed.

  3. Number of Participants With Abnormality in Clinical Chemistry Parameters [ Time Frame: Up to 3 years ]
    Number of participants with abnormality in clinical chemistry parameters were planned to be analyzed.

  4. Number of Participants With Abnormality in Vital Signs [ Time Frame: Up to 3 years ]
    Number of participants with abnormality in vital signs were planned to be analyzed.

  5. Number of Participants With Abnormality in Physical Examination [ Time Frame: Up to 3 years ]
    Number of participants with abnormality in physical examination were planned to be analyzed.

  6. Number of Participants Who Were Administered Concomitant Medications [ Time Frame: Up to 3 years ]
    Number of participants who were administered concomitant medications were planned to be analyzed.


Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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).
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02354586


Locations
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Sponsors and Collaborators
Tesaro, Inc.
Facing Our Risk of Cancer Empowered
Myriad Genetics, Inc.
Investigators
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Study Director: GSK Clinical Trials GlaxoSmithKline
  Study Documents (Full-Text)

Documents provided by Tesaro, Inc.:
Study Protocol  [PDF] December 21, 2017
Statistical Analysis Plan  [PDF] July 21, 2021

More Information
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Publications:

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Responsible Party: Tesaro, Inc.
ClinicalTrials.gov Identifier: NCT02354586    
Other Study ID Numbers: 213360
PR-30-5020-C ( Other Identifier: Tesaro )
First Posted: February 3, 2015    Key Record Dates
Results First Posted: April 9, 2020
Last Update Posted: September 15, 2022
Last Verified: July 2022
Keywords provided by Tesaro, Inc.:
gBRCAmut
BRCA
PARP inhibitor
HRD
 Ovarian cancer
Serous Epithelial
Fallopian Tube
Primary Peritoneal
Additional relevant MeSH terms:
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Ovarian Neoplasms
Carcinoma, Ovarian Epithelial
Endocrine Gland Neoplasms
Neoplasms by Site
Neoplasms
Ovarian Diseases
Adnexal Diseases
Genital Diseases, Female
Female Urogenital Diseases
Female Urogenital Diseases and Pregnancy Complications
Urogenital Diseases
Genital Neoplasms, Female
 Urogenital Neoplasms
Genital Diseases
Endocrine System Diseases
Gonadal Disorders
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Niraparib
Poly(ADP-ribose) Polymerase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents