NCT03551171 is a Phase 1 clinical trial of ZL-2306 (niraparib) in Ovarian Cancer, sponsored by Zai Lab (Shanghai) Co., Ltd..

Who is sponsoring NCT03551171?

NCT03551171 is sponsored by Zai Lab (Shanghai) Co., Ltd..

What drugs are being tested in NCT03551171?

Interventions in NCT03551171: ZL-2306 (niraparib).

What condition does NCT03551171 study?

NCT03551171 studies Ovarian Cancer.

Is NCT03551171 still recruiting?

NCT03551171 is currently completed. Last updated 24 January 2019.

Last reviewed 2019-01-24 · How we verify

NCT03551171

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

The Clinical Trial to Evaluate the Pharmacokinetics, Safety and Tolerability of ZL-2306 (Niraparib) in Patients With Ovarian Cancer

Completed Phase 1 Last updated 24 January 2019

What this trial tests

Phase 1 trial testing ZL-2306 (niraparib) in Ovarian Cancer in 42 participants. Completed in 10 July 2018.

Timeline

19 December 2017

Primary endpoint
3 May 2018

10 July 2018

Quick facts

Lead sponsor	Zai Lab (Shanghai) Co., Ltd.
Phase	Phase 1
Status	Completed
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	42
Start date	19 December 2017
Primary completion	3 May 2018
Estimated completion	10 July 2018
Sites	6 locations across China

Drugs / interventions tested

ZL-2306 (niraparib)

Conditions studied

Ovarian Cancer — all drugs for Ovarian Cancer →

Sponsor

Zai Lab (Shanghai) Co., Ltd. — full company profile →

Who can join

18 and older, female only, with Ovarian Cancer. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Niraparib is a potent and highly selective PARP-1/-2 inhibitor. The primary objective of this trial is to evaluate the pharmacokinetic (PK) properties of ZL-2306 (niraparib) and its metabolite M1 in patients from Mainland China with ovarian cancer, following a single and multiple oral administration of the study drug at the indicated dose (300mg, 200mg or 100mg), once a day.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

Phase I Pharmacokinetic Study of Niraparib in Chinese Patients with Epithelial Ovarian Cancer.
Zhang J, Zheng H, Gao Y, Lou G, et al · · 2020 · cited 10× · PMID 31439812 · DOI 10.1634/theoncologist.2019-0565

Verify or expand the search:

Other recruiting trials for Ovarian Cancer

Currently open trials in the same condition.

NCT06412120 — Study Evaluating Safety, Tolerability, and Metabolism of Niraparib · Phase 4 · recruiting
NCT06930755 — Study of NMS-03305293 in Adult Patients With Relapsed Ovarian Cancer · Phase 1 · recruiting
NCT07318558 — A Clinical Trial of Sac-TMT in People With Non-HRD Positive Advanced Ovarian Cancer (MK-2870-021) · Phase 3 · recruiting
NCT07491081 — EARLY Study: Evaluating the Specificity and Feasibility of the EARLY Biomarker Panel for Ovarian Cancer Detection · NA · recruiting
NCT07410676 — EBNK-001 Allogeneic NK Cells With Low-Dose IL-15 ± Pembrolizumab in Advanced Solid Tumors · Phase 1, PHASE2 · recruiting

Other Zai Lab (Shanghai) Co., Ltd. trials

Trials by the same sponsor.

NCT07211776 — A Study to Assess the Efficacy and Safety of ZL-1109 in Chinese Participants With Active Thyroid Eye Disease · Phase 3 · recruiting
NCT07235384 — A Phase 1/1b Study to Evaluate Safety, Tolerability and Pharmacokinetics of ZL-1503 in Healthy Volunteers and Participan · Phase 1 · recruiting
NCT07218146 — A Study of ZL-1310 Versus Investigator's Choice of Therapy in Participants With Relapsed Small Cell Lung Cancer (DLLEVAT · Phase 3 · recruiting
NCT06179069 — A Study of ZL-1310 in Subjects With Small Cell Lung Cancer · Phase 1 · recruiting
NCT05866354 — To Evaluate Pharmacokinetics of Tisotumab Vedotin in Chinese Subjects With Metastatic or Recurrent Solid Malignancies · Phase 1 · completed

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT03551171 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Zai Lab (Shanghai) Co., Ltd.
Last refreshed: 24 January 2019

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03551171.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing