Skip to main page content
U.S. flag

An official website of the United States government

Dot gov

The .gov means it’s official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you’re on a federal government site.

Https

The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

Access keys NCBI Homepage MyNCBI Homepage Main Content Main Navigation
Clinical Trial
. 2021 Mar;32(2):e16.
doi: 10.3802/jgo.2021.32.e16. Epub 2020 Dec 10.

Phase 2 single-arm study on the efficacy and safety of niraparib in Japanese patients with heavily pretreated, homologous recombination-deficient ovarian cancer

Aikou Okamoto  1 , Eiji Kondo  2 , Toshiaki Nakamura  3 , Satoshi Yanagida  1 , Junzo Hamanishi  4 , Kenichi Harano  5 , Kosei Hasegawa  6 , Takeshi Hirasawa  7 , Kensuke Hori  8 , Shinichi Komiyama  9 , Motoki Matsuura  10 , Hidekatsu Nakai  11 , Hiroko Nakamura  12 , Jun Sakata  13 , Tsutomu Tabata  14 , Kazuhiro Takehara  15 , Munetaka Takekuma  16 , Yoshihito Yokoyama  17 , Yoichi Kase  18 , Shuuji Sumino  19 , Junpei Soeda  20 , Ajit Suri  21 , Daisuke Aoki  22 , Toru Sugiyama  23
Affiliations
Clinical Trial

Phase 2 single-arm study on the efficacy and safety of niraparib in Japanese patients with heavily pretreated, homologous recombination-deficient ovarian cancer

Aikou Okamoto et al. J Gynecol Oncol. 2021 Mar.

Abstract

Objective: To evaluate the efficacy and safety of niraparib in Japanese women with heavily pretreated ovarian cancer.

Methods: This Phase 2 open-label, single-arm study enrolled Japanese women with homologous recombination deficiency-positive relapsed, high-grade serous ovarian, fallopian tube, or primary peritoneal cancer who had completed 3-4 lines of therapy. The starting dose of niraparib was 300 mg administered once daily in continuous 28-day cycles until objective progressive disease, unacceptable toxicity, consent withdrawal or discontinuation. The primary endpoint, objective response rate (ORR), was assessed by the investigator using RECIST version 1.1. Safety evaluations included the incidence of treatment-emergent adverse events (TEAEs), including serious TEAEs.

Results: Twenty women were enrolled and the confirmed ORR in the full analysis set (FAS) was 35.0% (7/20), consisting of 1 complete response and 6 partial responses. Disease control rate in the FAS was 90.0%. The most frequently reported TEAEs (>50%) were anemia, nausea, and platelet count decreased. One patient (5.0%) had TEAEs leading to discontinuation of niraparib whereas reductions or interruptions were reported in 14 (70.0%) and 15 (75.0%) patients, respectively. The median dose intensity (202.9 mg daily) corresponded to a relative dose intensity of 67.6%.

Conclusion: Efficacy and safety of niraparib in heavily pretreated Japanese women was comparable to that seen in an equivalent population of non-Japanese women. No new safety signals were identified.

Trial registration: ClinicalTrials.gov Identifier: NCT03759600.

Keywords: Japanese; Late-line Treatment; Niraparib; Ovarian Cancer; Phase 2; Salvage.

PubMed Disclaimer

Figures

Fig. 1
Fig. 1. Waterfall plot of ORR in FAS. Tumor BRCA1/2 mutation status is dichotomized as “Positive” or “Negative” (includes “Unknown”).
CR, complete response; FAS, full analysis set; ORR, objective response rate; PD, progressive disease; PR, partial response; SD, stable disease; SoD, sum of diameters. *Best overall response was determined as SD/PR as tumor shrinkage corresponding to PR/CR was observed at only one time point but was not confirmed at a subsequent time point before data cut-off as required for confirmation of CR or PR.
Fig. 2
Fig. 2. Kaplan-Meier plot of PFS in FAS.
FAS, full analysis set; PFS, progression-free survival.
See this image and copyright information in PMC

Comment in

References

    1. Yi M, Dong B, Qin S, Chu Q, Wu K, Luo S. Advances and perspectives of PARP inhibitors. Exp Hematol Oncol. 2019;8:29. - PMC - PubMed
    1. Sachdev E, Tabatabai R, Roy V, Rimel BJ, Mita MM. PARP inhibition in cancer: an update on clinical development. Target Oncol. 2019;14:657–679. - PubMed
    1. Mirza MR, Monk BJ, Herrstedt J, Oza AM, Mahner S, Redondo A, et al. Niraparib maintenance therapy in platinum-sensitive, recurrent ovarian cancer. N Engl J Med. 2016;375:2154–2164. - PubMed
    1. González-Martín A, Pothuri B, Vergote I, DePont Christensen R, Graybill W, Mirza MR, et al. Niraparib in patients with newly diagnosed advanced ovarian cancer. N Engl J Med. 2019;381:2391–2402. - PubMed
    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;20:636–648. - PubMed

Publication types

Associated data