NCT03075462 is a Phase 1 clinical trial of Fluzoparib in Ovarian Cancer, sponsored by Jiangsu HengRui Medicine Co., Ltd..

Who is sponsoring NCT03075462?

NCT03075462 is sponsored by Jiangsu HengRui Medicine Co., Ltd..

What drugs are being tested in NCT03075462?

Interventions in NCT03075462: Fluzoparib, Apatinib.

What condition does NCT03075462 study?

NCT03075462 studies Ovarian Cancer, Triple Negative Breast Cancer.

Is NCT03075462 still recruiting?

NCT03075462 is currently completed. Last updated 1 July 2022.

Last reviewed 2022-07-01 · How we verify

NCT03075462

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

A Study of Fluzoparib Given in Combination With Apatinib in Ovarian or Breast Cancer Patients

Completed Phase 1 Last updated 1 July 2022

What this trial tests

Phase 1 trial testing Fluzoparib in Ovarian Cancer in 98 participants. Completed in 13 December 2021.

Timeline

9 March 2017

Primary endpoint
22 August 2021

13 December 2021

Quick facts

Lead sponsor	Jiangsu HengRui Medicine Co., Ltd.
Phase	Phase 1
Status	Completed
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	98
Start date	9 March 2017
Primary completion	22 August 2021
Estimated completion	13 December 2021
Sites	1 location across China

Drugs / interventions tested

Fluzoparib — full drug profile →
Apatinib (Apatinib) — full drug profile →

Conditions studied

Ovarian Cancer — all drugs for Ovarian Cancer →
Triple Negative Breast Cancer — all drugs for Triple Negative Breast Cancer →

Sponsor

Jiangsu HengRui Medicine Co., Ltd. — full company profile →

Who can join

Adults 18 to 70, female only, with Ovarian Cancer or Triple Negative Breast Cancer. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Fluzoparib is an oral potent, selective poly-ADP ribose polymerase-1 (PARP-1) and PARP-2 inhibitor; Apatinib is an oral selective vascular endothelial growth factor receptor (VEGFR) inhibitor. This open-label, dose finding phase I trial studies the tolerability and the best dose of fluzoparib in combination with apatinib and to see how well these two drugs work together in the treatment of patients with recurrent ovarian cancer or triple negative breast cancer. The safety and efficacy of fluzoparib in combination with apatinib will be explored. Both dose escalation and dose expansion parts are included in this study.

Publications & conference data

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

Insights into Molecular Classifications of Triple-Negative Breast Cancer: Improving Patient Selection for Treatment.
Garrido-Castro AC, Lin NU, Polyak K. · · 2019 · cited 1061× · PMID 30679171 · DOI 10.1158/2159-8290.cd-18-1177
Racial Disparity and Triple-Negative Breast Cancer in African-American Women: A Multifaceted Affair between Obesity, Biology, and Socioeconomic Determinants.
Siddharth S, Sharma D. · · 2018 · cited 170× · PMID 30558195 · DOI 10.3390/cancers10120514
Tumor Microenvironment in Ovarian Cancer: Function and Therapeutic Strategy.
Yang Y, Yang Y, Yang J, Zhao X, et al · · 2020 · cited 168× · PMID 32850861 · DOI 10.3389/fcell.2020.00758
Triple-Negative Breast Cancer: Current Understanding and Future Therapeutic Breakthrough Targeting Cancer Stemness.
Lee KL, Kuo YC, Ho YS, Huang YH. · · 2019 · cited 164× · PMID 31505803 · DOI 10.3390/cancers11091334
Triple-negative breast cancer and the potential for targeted therapy.
Jhan JR, Andrechek ER. · · 2017 · cited 155× · PMID 29095114 · DOI 10.2217/pgs-2017-0117
Current status of poly(ADP-ribose) polymerase inhibitors and future directions.
Ohmoto A, Yachida S. · · 2017 · cited 96× · PMID 29138572 · DOI 10.2147/ott.s139336
Advances in the use of PARP inhibitor therapy for breast cancer.
McCann KE, Hurvitz SA. · · 2018 · cited 88× · PMID 30116283 · DOI 10.7573/dic.212540
Paradigm Shift: A Comprehensive Review of Ovarian Cancer Management in an Era of Advancements.
Tavares V, Marques IS, Melo IG, Assis J, et al · · 2024 · cited 85× · PMID 38339123 · DOI 10.3390/ijms25031845

Verify or expand the search:

Other trials of Fluzoparib

Trials testing the same drug.

NCT07353437 — Fluzoparib as Adjuvant Treatment in Patients With Germline Homologous Recombination Repair (HRR) Mutated Primary Breast · Phase 2 · not yet recruiting
NCT07382713 — Fluzoparib Plus Famitinib Maintenance After First-Line Platinum Response in Advanced Ovarian Cancer · Phase 2 · not yet recruiting
NCT07141771 — An Umbrella Study of Recurrent, Extensive Stage Small Cell Lung Cancer Based on Molecular Typing · Phase 1, PHASE2 · not yet recruiting
NCT06735326 — Fluzoparib With or Without Bevacizumab for Neoadjuvant Therapy in Advanced Ovarian Cancer · Phase 2 · recruiting
NCT06539091 — Fluzoparib in Combination With Apatinib Mesylate for Maintenance Therapy in Stage III-IV Ovarian Cancer · Phase 3 · not yet recruiting

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 Jiangsu HengRui Medicine Co., Ltd. trials

Trials by the same sponsor.

NCT07252921 — Safety and Efficacy of HRS-9190 Compared to Rocuronium for Tracheal Intubation in Adults · Phase 2 · completed
NCT07142850 — A Phase I Study of the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Intravenous Bolus and Infusion HR · Phase 1 · completed
NCT07073157 — Effect of HRS-8427 for Injection on the Pharmacokinetics of Furosemide and Metformin in Healthy Subjects。 · Phase 1 · completed
NCT07076459 — A Comparative Pharmacokinetic Study of Single-Dose Administration of HR091506 Tablets From Different Batches in Healthy · Phase 1 · completed
NCT07049107 — Pharmacokinetics Impact of HRS-8427 on Bupropion and Midazolam in Healthy Subjects · 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 NCT03075462 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 9 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 Jiangsu HengRui Medicine Co., Ltd.
Last refreshed: 1 July 2022

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/NCT03075462.

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