Evidence map›Paper›PMID 31439812›Full record

Trial reportThe oncologist2020

Phase I Pharmacokinetic Study of Niraparib in Chinese Patients with Epithelial Ovarian Cancer.

Jian Zhang, Hong Zheng, Yunong Gao, Ge Lou, Rutie Yin, Dongmei Ji, Wenhua Li, Wei Wang, Bairong Xia, Danqing Wang and 6 more

Abstract readClinical Trial, Phase IRandomized Controlled Trial
In one paragraph

Trial report in The oncologist, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 11 papers.

0numbers the graph read from it
0cells of the map it votes in
11citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

11 citing papers in PubMed.

  1. Trial
  2. Article
  3. Article
  4. Article
  5. Review
  6. Article
  7. Review
  8. Review
  9. Article
  10. Article
  11. Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

16 authors.

Jian ZhangDepartment of Medical Oncology, Fudan University Shanghai Cancer Center, Shanghai, People's Republic of China.
Hong ZhengDepartment of Gynecology, Key Laboratory of Carcinogenesis and Translational Research (Ministry of Education/Beijing), Peking University Cancer Hospital & Institute, Beijing, People's Republic of China.
Yunong GaoDepartment of Gynecology, Key Laboratory of Carcinogenesis and Translational Research (Ministry of Education/Beijing), Peking University Cancer Hospital & Institute, Beijing, People's Republic of China.
Ge LouDepartment of Gynecology, Harbin Medical University Cancer Hospital, Harbin, People's Republic of China.
Rutie YinDepartment of Gynecology and Obstetrics, West China Second Hospital of Sichuan University, Chengdu, People's Republic of China.
Dongmei JiDepartment of Medical Oncology, Fudan University Shanghai Cancer Center, Shanghai, People's Republic of China.
Wenhua LiDepartment of Medical Oncology, Fudan University Shanghai Cancer Center, Shanghai, People's Republic of China.
Wei WangDepartment of Gynecology, Key Laboratory of Carcinogenesis and Translational Research (Ministry of Education/Beijing), Peking University Cancer Hospital & Institute, Beijing, People's Republic of China.
Bairong XiaDepartment of Gynecology, Harbin Medical University Cancer Hospital, Harbin, People's Republic of China.
Danqing WangDepartment of Gynecology and Obstetrics, West China Second Hospital of Sichuan University, Chengdu, People's Republic of China.
Jianmei HouDepartment of Research and Development, Zai Lab, Shanghai, People's Republic of China.
James YanDepartment of Research and Development, Zai Lab, Shanghai, People's Republic of China.
Yongjiang HeiDepartment of Research and Development, Zai Lab, Shanghai, People's Republic of China.
Zhi-Yi ZhangClinical Pharmacology, TESARO Inc., Waltham, Massachusetts, USA.
Ashley MiltonClinical Pharmacology, TESARO Inc., Waltham, Massachusetts, USA.
Xiaohua WuDepartment of Oncology, Shanghai Medical College, Fudan University, Shanghai, People's Republic of China.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

lessons learnedPharmacokinetics characteristics of niraparib in Chinese patients were similar to those in white patients. Niraparib could be well tolerated by Chinese patients, and adverse events were manageable in this study. Population pharmacokinetics analysis indicated that baseline body weight had a modest impact on pharmacokinetics parameters of niraparib; however, it was not considered clinically important.

backgroundThis randomized, open-label, single-arm, phase I study was designed to investigate the pharmacokinetics (PK) and safety of niraparib in Chinese patients with epithelial ovarian cancer.

methodsEligible patients were randomized in a 1:1:1 ratio to receive 100, 200, or 300 mg of niraparib once daily. PK parameters were analyzed after single and multiple dose administrations.

resultsThirty-six Chinese patients were enrolled in total. Niraparib was rapidly absorbed after administration, and median time-to-peak (T

conclusionThe PK profile of niraparib in Chinese patients is consistent with that in white patients. Niraparib is safe and well tolerated in Chinese patients with ovarian cancer.

Indexed as

FemaleHumansIndazolesOvarian NeoplasmsPiperidinesPoly(ADP-ribose) Polymerase InhibitorsIndazolesniraparibPiperidinesPoly(ADP-ribose) Polymerase Inhibitors

Identifiers

PMID31439812
PMCPMC6964144

What OpenQuestion holds

Textmetadata
Read underepoch 390

Registered trials

None linked

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.