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

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ClinicalTrials.gov Identifier: NCT02354586
Recruitment Status : Active, not recruiting
First Posted : February 3, 2015
Last Update Posted : May 17, 2019
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
Last Update Posted Date May 17, 2019
Study Start Date  ICMJE March 2015
Actual Primary Completion Date February 28, 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 29, 2015)
Evaluate antitumor activity of niraparib [ Time Frame: 6 months ]
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT02354586 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: July 19, 2016)
  • 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 gBRCAmut positive patients
  • 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.
  • Overall Survival [ Time Frame: 6 months ]
    Time from enrollment to the date of death by any cause.
  • 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 ]
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 Not Provided
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 Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Ovarian Cancer
Intervention  ICMJE Drug: Niraparib
Study Arms  ICMJE Experimental: Niraparib
Intervention: Drug: Niraparib
Publications * Not Provided

*   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 Active, not recruiting
Estimated Enrollment  ICMJE
 (submitted: June 9, 2017)
500
Original Estimated Enrollment  ICMJE
 (submitted: January 29, 2015)
225
Estimated Study Completion Date  ICMJE December 2019
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 PR-30-5020-C
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 Not Provided
PRS Account Tesaro, Inc.
Verification Date May 2019

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