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QUADRA

Niraparib monotherapy for late-line treatment of ovarian cancer (QUADRA): a multicentre, open-label, single-arm, phase 2 trial

Phase 2N = 463NCT02354586

Population
Relapsed high-grade serous epithelial ovarian, fallopian tube or primary peritoneal cancer after three or more chemotherapy regimens (median four prior lines); primary efficacy population: HRD-positive, platinum-sensitive disease after three or four prior regimens (n=47)
Design
Multicentre, open-label, single-arm phase 2 study of niraparib 300 mg once daily in relapsed high-grade serous (grade 2 or 3) epithelial ovarian, fallopian tube or primary peritoneal cancer after three or more previous chemotherapy regimens. The primary objective was investigator-assessed confirmed overall response in HRD-positive, platinum-sensitive tumours after three or four previous regimens (primary efficacy population).
Primary endpoint
ORR
Arms
  • Niraparib (experimental, n = 463): Niraparib 300 mg once daily
People
Moore KN
Show the numbers
Results reported for QUADRA
EndpointAnalysisNiraparibControlEffect
ORRPrimary efficacy population: HRD-positive, platinum-sensitive, three or four previous regimens (n=47)primaryMoore 201928% (15.6–42.6%)—P=0.00053 (one-sided)Investigator-assessed confirmed response, 13 of 47 patients; 463 patients were enrolled.
Results reported for QUADRA
EndpointAnalysisNiraparibControlEffect
ORRPrimary efficacy population: HRD-positive, platinum-sensitive, three or four previous regimens (n=47)primaryMoore 201928% (15.6–42.6%)—P=0.00053 (one-sided)Investigator-assessed confirmed response, 13 of 47 patients; 463 patients were enrolled.
Primary publication: Moore KN, Secord AA, Geller MA, Miller DS, Cloven N, Fleming GF, et al. Niraparib monotherapy for late-line treatment of ovarian cancer (QUADRA): a multicentre, open-label, single-arm, phase 2 trial. Lancet Oncol. 2019;20(5):636-648. PubMedDOI

Appears in

Sources

  1. Moore KN, Secord AA, Geller MA, Miller DS, Cloven N, Fleming GF, et al. Niraparib monotherapy for late-line treatment of ovarian cancer (QUADRA): a multicentre, open-label, single-arm, phase 2 trial. Lancet Oncol. 2019;20(5):636-648.

    PubMedDOI