HRD is defined by either a deleterious or suspected deleterious Efficacy was investigated in 98 patients with advanced ovarian cancer with HRD-positive tumors in the single-arm QUADRA (NCT02354586) trial. Patients were assigned to one of two cohorts based on the BRACAnalysis CDx.
FDA approved this application approximately three months ahead of the goal date.
Adverse reactions led to dose reduction or interruption in 73% of patients receiving niraparib in QUADRA.
The objective of this study was to determine the cost effectiveness of niraparib maintenance therapy in patients with newly diagnosed ovarian cancer.
QUADRA was a multicentre, open-label, single-arm, phase 2 study that evaluated the safety and activity of niraparib in adult patients (≥18 years) with relapsed, high-grade serous (grade 2 or 3) epithelial ovarian, fallopian tube, or primary peritoneal cancer who had been treated with three or more previous chemotherapy regimens. A description of FDA expedited programs is in the Healthcare professionals should report all serious adverse events suspected to be associated with the use of any medicine and device to FDA’s For assistance with single-patient INDs for investigational oncology products, healthcare professionals may contact OCE’s (niraparib) capsules, for oral use Initial U.S. Approval: 2017 MDS/AML occurred in patients exposed to ZEJULA, and some cases were ... Grade 3-4 hypertension occurred in 5% of ZEJULA-treated patients in QUADRA with a median time from first dose to first onset of …
Patients were treated with three or more prior lines of chemotherapy.
One death due to gastric haemorrhage was considered treatment related.We observed clinically relevant activity of niraparib among women with heavily pretreated ovarian cancer, especially in patients with HRD-positive platinum-sensitive disease, which includes not only patients with a We use cookies to help provide and enhance our service and tailor content and ads.
Methods QUADRA was a multicentre, open-label, single-arm, phase 2 study that evaluated the safety and activity of niraparib in adult patients (≥18 years) with relapsed, high-grade serous (grade 2 or 3) epithelial ovarian, fallopian tube, or primary peritoneal cancer who had been treated with three or more previous chemotherapy regimens. 00053). Matulonis UA, Monk BJ, Secord AA, et al.
Methods.
QUADRA evaluated niraparib monotherapy in ROC pts regardless of their plat and biomarker status. Niraparib also improved progression-free survival in the HRD-negative subgroup (median, 6.9 months vs. 3.8 months; hazard ratio, 0.58; 95% CI, 0.36 to 0.92; P=0.02) (Fig.
ScienceDirect ® is a registered trademark of Elsevier B.V.Niraparib monotherapy for late-line treatment of ovarian cancer (QUADRA): a multicentre, open-label, single-arm, phase 2 trialScienceDirect ® is a registered trademark of Elsevier B.V.
However, rates of most common adverse reactions observed in QUADRA were different from NOVA, and fatal adverse reactions occurred in 2% of patients, including cardiac arrest.
The most common adverse reactions occurring in at least 10% of patients receiving niraparib were thrombocytopenia, anemia, neutropenia, leukopenia, palpitations, nausea, constipation, vomiting, abdominal pain/distention, mucositis/stomatitis, diarrhea, dyspepsia, dry mouth, fatigue, decreased appetite, urinary tract infection, AST/ALT elevation, myalgia, back pain, arthralgia, headache, dizziness, dysgeusia, insomnia, anxiety, nasopharyngitis, dyspnea, cough, rash, and hypertension.
Niraparib’s safety was evaluated in 367 patients with platinum-sensitive recurrent ovarian, fallopian tube, and primary peritoneal cancer in the NOVA trial. QUADRA (NCT02354586) evaluated niraparib active treatment in ROC pts. ZEJULA® (niraparib) - Maintenance Treatment for Recurrent Ovarian Cancer In the PRIMA trial, ZEJULA was assessed in patients with HRd tumors and then in the overall population 1,2 The overall population included1*: *The PRIMA trial included adult patients with advanced epithelial ovarian, fallopian tube, or primary peritoneal cancer.
Pts were evaluated for BRCAmut and HRD status (MyChoice HRD Test).
Baseline platelet count and body weight as predictors of early dose modification in the QUADRA trial of niraparib monotherapy for the treatment of heavily pretreated (≥4th line), advanced, recurrent high-grade serous ovarian cancer.
Listing a study does not mean it has been evaluated by the U.S. Federal Government. Use of any third-party website is at your own risk and subject to the third-party website’s privacy policy and terms and conditions.GSK does not own or control the content of or guarantee the information on the site you have selected. Patients were randomized (2:1) within 8 weeks of the last therapy to either niraparib (300 mg orally daily) or matched placebo. In QUADRA, serious adverse reactions occurred in 43% of patients receiving ZEJULA.
Objectives Niraparib maintenance after frontline chemotherapy for advanced ovarian cancer extends progression free survival. QUADRA was a multicentre, open-label, single-arm, phase 2 study that evaluated the safety and activity of niraparib in adult patients (≥18 years) with relapsed, high-grade serous (grade 2 or 3) epithelial ovarian, fallopian tube, or primary peritoneal cancer who had been treated with three or more previous chemotherapy regimens.
Recent nonclinical studies, 21 together with the NOVA 7 and QUADRA 8 clinical trials, have shown the effectiveness of niraparib in treating patients with wild-type BRCA tumors.
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