NCT03945084

Maintenance With Niraparib In Patients With Advanced Urothelial Cancer After 1st-line Platinum-based Chemotherapy

Completed Phase 2 Last updated 23 May 2022

What this trial tests

Phase 2 trial testing Niraparib in Urothelial Carcinoma in 58 participants. Completed in 1 September 2021.

Timeline

27 August 2019

Primary endpoint
1 September 2021

1 September 2021

Quick facts

Lead sponsor	University of Turin, Italy
Phase	Phase 2
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	58
Start date	27 August 2019
Primary completion	1 September 2021
Estimated completion	1 September 2021
Sites	20 locations across Italy

Drugs / interventions tested

• Niraparib (niraparib) — full drug profile →
• Best supportive care

Conditions studied

• Urothelial Carcinoma — all drugs for Urothelial Carcinoma →

Sponsor

University of Turin, Italy

Who can join

18 and older, any sex, with Urothelial Carcinoma. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

This is a 2-arm, prospective, randomized (2:1 ratio), open-label, multi-centre, phase II study conducted in patients affected by unresectable, locally advanced or metastatic urothelial cancer receiving niraparib plus best supportive care versus best supportive care as maintenance therapy after a first-line platinum-based chemotherapy.

The primary objective of the trial is to evaluate the efficacy of niraparib plus Best Supportive Care (BSC) vs. BSC alone, as maintenance treatment, in terms of prolongation of progression-free survival (PFS), in patients with locally advanced or metastatic urothelial cancer that obtained disease control (objective response or stable disease) with first-line platinum-based chemotherapy.

Publications & conference data

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

1. Current Strategies and Novel Therapeutic Approaches for Metastatic Urothelial Carcinoma.
   Mollica V, Rizzo A, Montironi R, Cheng L, et al · · 2020 · cited 75× · PMID 32498352 · DOI 10.3390/cancers12061449
2. Homologous Recombination Deficiency Scar: Mutations and Beyond-Implications for Precision Oncology.
   van der Wiel AMA, Schuitmaker L, Cong Y, Theys J, et al · · 2022 · cited 17× · PMID 36077694 · DOI 10.3390/cancers14174157
3. Combination of Talazoparib and Palbociclib as a Potent Treatment Strategy in Bladder Cancer.
   Klein FG, Granier C, Zhao Y, Pan Q, et al · · 2021 · cited 14× · PMID 33923231 · DOI 10.3390/jpm11050340
4. PARP Inhibitors in Prostate and Urothelial Cancers.
   Garje R, Vaddepally RK, Zakharia Y. · · 2020 · cited 11× · PMID 32117762 · DOI 10.3389/fonc.2020.00114
5. Genomics and Immunomics in the Treatment of Urothelial Carcinoma.
   Mollica V, Massari F, Rizzo A, Ferrara R, et al · · 2022 · cited 10× · PMID 35621673 · DOI 10.3390/curroncol29050283
6. Incidence and risk of endocrine and metabolic abnormalities linked to PARP inhibitors in solid tumors: a meta-analysis.
   Fu S, Zou P, Fang Z, Zhou X, et al · · 2025 · cited 5× · PMID 39891102 · DOI 10.1186/s12885-025-13579-1
7. Genomic Profiling and Molecular Characterisation of Metastatic Urothelial Carcinoma.
   Pezzicoli G, Ciciriello F, Musci V, Minei S, et al · · 2024 · cited 3× · PMID 38674231 · DOI 10.3390/medicina60040585
8. PARP Inhibitors in Genitourinary Cancer: A New Paradigm Beyond Prostate Cancer.
   Okuda Y, Kato T, Ishizuya Y, Hayashi T, et al · · 2025 · cited 1× · PMID 40488739 · DOI 10.1111/iju.70100