NCT03705156

Clinical Trial Evaluating the Efficacy and Safety of ZL-2306 (Niraparib) in Ovarian Cancer Patient

Status unknown Phase 3 Last updated 13 April 2023

What this trial tests

Phase 3 trial testing ZL-2306(nirapairb) in Platinum-sensitive Relapsed Ovarian Cancer in 265 participants. Status unknown.

Timeline

8 June 2017

Primary endpoint
1 February 2020

24 August 2024

Quick facts

Lead sponsor	Zai Lab (Shanghai) Co., Ltd.
Phase	Phase 3
Status	Status unknown
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	quadruple
Primary purpose	treatment
Enrollment	265
Start date	8 June 2017
Primary completion	1 February 2020
Estimated completion	24 August 2024
Sites	27 locations across China

Drugs / interventions tested

• ZL-2306(nirapairb)
• Placebos — full drug profile →

Conditions studied

• Platinum-sensitive Relapsed Ovarian Cancer — all drugs for Platinum-sensitive Relapsed Ovarian Cancer →

Sponsor

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

Who can join

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

Sponsor's own description

This is a 2:1 randomized, double-blind, placebo-controlled, multi-center, phase III clinical study evaluating the efficacy and safety of ZL-2306 (niraparib) for maintenance treatment in patients with platinum-sensitive relapsed ovarian cancer, fallopian tube carcinoma or primary peritoneal cancer (collectively referred to as relapsed ovarian cancer).The evaluation will be divided into two stages: Stage I will be conducted in all patients, and if the predetermined statistically significant difference is not reached, the trial will continue to extend to Stage II during which evaluation will be performed in gBRCA mutation-positive ovarian cancer patients.

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

1. Niraparib maintenance therapy in patients with platinum-sensitive recurrent ovarian cancer using an individualized starting dose (NORA): a randomized, double-blind, placebo-controlled phase III trial^☆.
   Wu XH, Zhu JQ, Yin RT, Yang JX, et al · · 2021 · cited 144× · PMID 33453391 · DOI 10.1016/j.annonc.2020.12.018
2. PARP Inhibitors in Ovarian Cancer: A Review.
   O'Malley DM, Krivak TC, Kabil N, Munley J, et al · · 2023 · cited 128× · PMID 37268756 · DOI 10.1007/s11523-023-00970-w
3. Mechanism of PARP inhibitor resistance and potential overcoming strategies.
   Fu X, Li P, Zhou Q, He R, et al · · 2024 · cited 45× · PMID 37588193 · DOI 10.1016/j.gendis.2023.02.014
4. Safety and management of niraparib monotherapy in ovarian cancer clinical trials.
   Monk BJ, González-Martin A, Buckley L, Matulonis UA, et al · · 2023 · cited 26× · PMID 36792166 · DOI 10.1136/ijgc-2022-004079
5. Application of PARP inhibitors combined with immune checkpoint inhibitors in ovarian cancer.
   Xiao F, Wang Z, Qiao L, Zhang X, et al · · 2024 · cited 18× · PMID 39169400 · DOI 10.1186/s12967-024-05583-z
6. Efficacy and safety of PARP inhibitors in elderly patients with advanced ovarian cancer: a systematic review and meta-analysis.
   Maiorano BA, Maiorano MFP, Lorusso D, Di Maio M, et al · · 2022 · cited 18× · PMID 36229080 · DOI 10.1136/ijgc-2022-003614
7. Niraparib maintenance therapy using an individualised starting dose in patients with platinum-sensitive recurrent ovarian cancer (NORA): final overall survival analysis of a phase 3 randomised, placebo-controlled trial.
   Wu X, Zhu J, Yin R, Yang J, et al · · 2024 · cited 14× · PMID 38745967 · DOI 10.1016/j.eclinm.2024.102629
8. Update on Poly ADP-Ribose Polymerase Inhibitors in Ovarian Cancer With Non-BRCA Mutations.
   Xu Q, Li Z. · · 2021 · cited 14× · PMID 34912215 · DOI 10.3389/fphar.2021.743073