Newton Study (NEW Dosing MainTenance Therapy Ovarian CaNcer)

Phase 2 Terminated 83 enrolled Mario Negri Institute for Pharmacological Research North Eastern German Society of Gynaecological Oncology · collab

RandomizedParallel-groupOpen-labelTreatment

Summary

This study evaluates whether the adoption of the RADAR dosing strategy could further reduce treatment related toxicities improving the safety profile of niraparib.

Timeline

Start: 2019-11-13
Primary completion: 2024-08-31
Completion: 2024-08-31

Outcome

Met primary endpoint

Stopped (Enrollment): “Low accrual rate”

paper lower G≥ 3 thrombocytopenia incidence was observed in the RADAR compared to standard arm (4.2%, vs 41.7%, corresponding to a difference of -37.5% PMID 41950571 ↗

paper Z-test p= 0.0044 PMID 41950571 ↗

Publications

Colombo N, Parma G, Tasca G, Di Palma MP, Tognon G, Lissoni AA, Fossati R, Carlucci L, Zucchetti M, Matteo C, Ferrero A, Bologna A, Mantiero M, Wimberger P, Katsaros D, Tomao F, Galli F, Lapresa M, Guarneri V, Ficarelli S, Canova S, Derio S, Girardi F, Zizioli V, Katrini J, Massa D, Rulli E, Biagioli E; NEWTON study group. Rational adjustment of dose to reduce adverse reactions (RADAR) in patients with platinum-sensitive recurrent ovarian cancer: Results from the phase II NEWTON trial (ENGOT-ov49). Eur J Cancer. 2026 May 15;239:116685. doi: 10.1016/j.ejca.2026.116685. Epub 2026 Mar 27.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Niraparib	Small molecule	200 mg	Oral
Subject	Niraparib	Small molecule	300 mg	Oral