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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 : October 21, 2021
Sponsor:
Collaborators:
Facing Our Risk of Cancer Empowered
Myriad Genetics, Inc.
Information provided by (Responsible Party):
Tesaro, Inc.

Tracking Information
First Submitted Date  ICMJE January 23, 2015
First Posted Date  ICMJE February 3, 2015
Results First Submitted Date  ICMJE March 25, 2020
Results First Posted Date  ICMJE April 9, 2020
Last Update Posted Date October 21, 2021
Actual Study Start Date  ICMJE March 23, 2015
Actual Primary Completion Date February 28, 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 25, 2020)
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). 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.
Original Primary Outcome Measures  ICMJE
 (submitted: January 29, 2015)
Evaluate antitumor activity of niraparib [ Time Frame: 6 months ]
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: March 25, 2020)
  • 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.
  • 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). ORR was evaluated for participants with following characteristics: HRD status (positive, negative and unknown) and BRCA status (mutation positive, wild-type and unknown).
  • 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.
  • 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.
  • 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.
  • 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.
Original Secondary Outcome Measures  ICMJE
 (submitted: January 29, 2015)
  • Evaluate durability of anti-cancer activity (i.e. time from first response, CR or PR until disease progression). [ Time Frame: 6 months ]
    The evaluation is measured by clinical review of adverse events (AEs), physical examinations, electrocardiograms (ECGs), RECIST tumor assessments and safety laboratory values.
  • Evaluate antitumor activity of niraparib in HRD+ and gBRCAmut [ Time Frame: 6 months ]
    To evaluate antitumor activity of niraparib in homologous recombination deficiency (HRD) positive patients and in patients with germline breast cancer gene mutation (gBRCAmut)
  • Disease Control Rate (DCR) [ Time Frame: 6 months ]
  • Progression Free Survival [ Time Frame: 6 months ]
    Time from enrollment to the earlier date of assessment of progression by any cause in the absence of progression per RECIST (v.1.1) or clinical criteria, or death.
  • Evaluate the safety and tolerability of niraparib in ovarian cancer patients (Review of adverse events, concomitant medications, physical exams, electrocardiograms (ECGs), and safety lab values.) [ Time Frame: 6 months ]
Current Other Pre-specified Outcome Measures
 (submitted: March 25, 2020)
  • Number of Participants With Any Non-serious Adverse Event (Non-SAE) or Any SAE [ Time Frame: Up to 3 years ]
    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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Study of Niraparib in Patients With Ovarian Cancer Who Have Received Three or Four Previous Chemotherapy Regimens
Official Title  ICMJE 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
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Ovarian Neoplasms
  • Ovarian Cancer
Intervention  ICMJE Drug: Niraparib
Study Arms  ICMJE Experimental: Niraparib
Intervention: Drug: Niraparib
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: March 25, 2020)
463
Original Estimated Enrollment  ICMJE
 (submitted: January 29, 2015)
225
Actual Study Completion Date  ICMJE August 23, 2021
Actual Primary Completion Date February 28, 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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).
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Canada,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02354586
Other Study ID Numbers  ICMJE 213360
PR-30-5020-C ( Other Identifier: Tesaro )
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Tesaro, Inc.
Study Sponsor  ICMJE Tesaro, Inc.
Collaborators  ICMJE
  • Facing Our Risk of Cancer Empowered
  • Myriad Genetics, Inc.
Investigators  ICMJE
Study Director: GSK Clinical Trials GlaxoSmithKline
PRS Account Tesaro, Inc.
Verification Date September 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP