Last updated: 08/21/2022 21:10:43

A study of Niraparib in Patients with Ovarian Cancer who have received three or four previous chemotherapy regimensQUADRA

GSK study ID
213360
See study documents
Clinicaltrials.gov ID
NCT02354586
See results summary
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Study complete
Study complete
Overview
Eligibility
Locations
Study documents
Results summary
Plain language summaries
Additional information

Trial overview

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
Trial description: 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.
Primary purpose:
Treatment
Trial design:
Single Group Assignment
Masking:
None (Open Label)
Allocation:
Not applicable
Primary outcomes:

Objective response rate (ORR)

Timeframe: Up to 3 years

Secondary outcomes:

Duration of response (DoR)

Timeframe: Up to 3 years

ORR by HRD status and breast cancer gene (BRCA) status

Timeframe: Up to 3 years

Disease Control Rate (DCR)

Timeframe: Up to 3 years

Progression Free Survival

Timeframe: Up to 3 years

Overall Survival

Timeframe: Up to 3 years

Time to First Subsequent Therapy (TFST)

Timeframe: Up to 3 years

Interventions:
  • Drug: Niraparib
    • Enrollment:
    463
    Primary completion date:
    2018-28-02
    Observational study model:
    Not applicable
    Time perspective:
    Not applicable
    Clinical publications:
    Moore KN, Secord AA, Geller MA, Miller DS, Cloven NG, Fleming GF, Wahner-Hendrickson AE, Azodi M, DiSilvestro P, Oza AM, Cristea MC, Berek JS, Chan JK, Rimel BJ, Li Y, Matei D, Sun K, Luptakova K, Matolunis UA, Monk BJ. Niraparib monotherapy for the treatment of heavily pretreated advanced, recurrent high-grade serous ovarian cancer: results from the single-arm phase 2 QUADRA trial. Lancet Oncol. 2019;20(5):636-648
    Medical condition
    Ovarian Neoplasms
    Product
    Not applicable
    Collaborators
    Facing Our Risk of Cancer Empowered (FORCE), Myriad Genetics
    Study date(s)
    March 2015 to August 2021
    Type
    Interventional
    Phase
    2

    Participation criteria

    Sex
    Female
    Age
    18+ years
    Accepts healthy volunteers
    No
    • 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 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.
    Inclusion and exclusion 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).

    Trial location(s)

    Location
    Status
    Contact us
    Contact us
    Location
    GSK Investigational Site
    Atlanta, Georgia, United States, 30342
    Status
    Study Complete
    Contact us
    Location
    GSK Investigational Site
    Austin, Texas, United States, 78731
    Status
    Study Complete
    Contact us
    Location
    GSK Investigational Site
    Baltimore, Maryland, United States, 21202
    Status
    Study Complete
    Contact us
    Location
    GSK Investigational Site
    Boston, Massachusetts, United States, 02115
    Status
    Study Complete
    Contact us
    Location
    GSK Investigational Site
    Boston, Massachusetts, United States, 02215
    Status
    Study Complete
    Contact us
    Location
    GSK Investigational Site
    Burbank, California, United States, 91505
    Status
    Study Complete
    Contact us
    Showing 1 - 6 of 55 Results

    Study documents

    Protocol
    Available language(s): English
    Download document(s)
    Statistical analysis plan
    Available language(s): English
    Download document(s)

    If you wish to request for full study report, please contact - [email protected]

    Results overview

    Results posted on ClinicalTrials.gov

    Recruitment status
    Study complete
    Actual primary completion date
    2018-28-02
    Actual study completion date
    2021-23-08

    Plain language summaries

    Plain language summaries of clinical trial results for Phase 2-4 clinical trials that were initiated on or after January 2022 will be posted by GSK within one year following study completion.

    Additional information about the trial

    Additional information
    Not applicable
    Participate in clinical trial
    Access to clinical trial data by researchers
    Visit website