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
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Study complete
Study complete
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:
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
GSK Investigational Site
Atlanta, Georgia, United States, 30342
Status
Study Complete
Location
GSK Investigational Site
Baltimore, Maryland, United States, 21202
Status
Study Complete
Location
GSK Investigational Site
Boston, Massachusetts, United States, 02115
Status
Study Complete
Location
GSK Investigational Site
Boston, Massachusetts, United States, 02215
Status
Study Complete
Location
GSK Investigational Site
Burbank, California, United States, 91505
Status
Study Complete
Location
GSK Investigational Site
Burlington, Massachusetts, United States, 01805
Status
Study Complete
Location
GSK Investigational Site
Chandler, Arizona, United States, 85224
Status
Study Complete
Location
GSK Investigational Site
Chicago, Illinois, United States, 60611
Status
Study Complete
Location
GSK Investigational Site
Chicago, Illinois, United States, 60637
Status
Study Complete
Location
GSK Investigational Site
Covington, Louisiana, United States, 70433
Status
Study Complete
Location
GSK Investigational Site
Duarte, California, United States, 91010
Status
Study Complete
Location
GSK Investigational Site
Durham, North Carolina, United States, 27710
Status
Study Complete
Location
GSK Investigational Site
East Setauket, New York, United States, 11733
Status
Study Complete
Location
GSK Investigational Site
Fort Worth, Texas, United States, 76104
Status
Study Complete
Location
GSK Investigational Site
Hackensack, New Jersey, United States, 07601
Status
Study Complete
Location
GSK Investigational Site
Indianapolis, Indiana, United States, 54244
Status
Study Complete
Location
GSK Investigational Site
Indianapolis, Indiana, United States, 46260
Status
Study Complete
Location
GSK Investigational Site
Jamaica, New York, United States, 11432
Status
Study Complete
Location
GSK Investigational Site
LOS ANGELES, California, United States, 90048
Status
Study Complete
Location
GSK Investigational Site
Lake Success, New York, United States, 11042
Status
Study Complete
Location
GSK Investigational Site
Los Angeles, California, United States, 90027
Status
Study Complete
Location
GSK Investigational Site
Medford, Oregon, United States, 97504-8342
Status
Study Complete
Location
GSK Investigational Site
Minneapolis, Minnesota, United States, 55455
Status
Study Complete
Location
GSK Investigational Site
Morristown, New Jersey, United States, 07962-1956
Status
Study Complete
Location
GSK Investigational Site
Nashville, Tennessee, United States, 37203
Status
Study Complete
Location
GSK Investigational Site
New Haven, Connecticut, United States, 06510
Status
Study Complete
Location
GSK Investigational Site
New Orleans, Louisiana, United States, 70121
Status
Study Complete
Location
GSK Investigational Site
New York, New York, United States, 10065
Status
Study Complete
Location
GSK Investigational Site
Oklahoma City, Oklahoma, United States, 73104
Status
Study Complete
Location
GSK Investigational Site
Phoenix, Arizona, United States, 85016
Status
Study Complete
Location
GSK Investigational Site
Providence, Rhode Island, United States, 02905
Status
Study Complete
Location
GSK Investigational Site
Rochester, Minnesota, United States, 55905
Status
Study Complete
Location
GSK Investigational Site
San Antonio, Texas, United States, 78229
Status
Study Complete
Location
GSK Investigational Site
San Francisco, California, United States, 94118
Status
Study Complete
Location
GSK Investigational Site
Santa Barbara, California, United States, 93105
Status
Study Complete
Location
GSK Investigational Site
Spokane, Washington, United States, 99202
Status
Study Complete
Location
GSK Investigational Site
Springfield, Missouri, United States, 65804
Status
Study Complete
Location
GSK Investigational Site
Stanford, California, United States, 94305-5317
Status
Study Complete
Location
GSK Investigational Site
Tacoma, Washington, United States, 98405
Status
Study Complete
Location
GSK Investigational Site
The Woodlands, Texas, United States, 77380
Status
Study Complete
Location
GSK Investigational Site
West Palm Beach, Florida, United States, 33401
Status
Study Complete
Location
GSK Investigational Site
Wynnewood, Pennsylvania, United States, 19096
Status
Study Complete
Location
GSK Investigational Site
Ann Arbor, Michigan, United States, 48109
Status
Study Complete
Study documents
Protocol
Available language(s): English
Statistical analysis plan
Available language(s): English
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
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