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Newton Study (NEW Dosing MainTenance Therapy Ovarian CaNcer)

NCT03891576 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 83

Last updated 2025-01-17

No results posted yet for this study

Summary

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

Conditions

Interventions

DRUG

Niraparib

Niraparib is a potent, orally active PARP1 and PARP2 inhibitor being developed as a treatment for patients with tumors that harbor defects in the homologous recombination DNA repair pathway or that are driven by PARP-mediated transcription factors.

Sponsors & Collaborators

  • North Eastern German Society of Gynaecological Oncology

    collaborator OTHER

  • Mario Negri Institute for Pharmacological Research

    lead OTHER

Principal Investigators

  • Nicoletta Colombo, MD · Istituto Europeo di Oncologia (IEO) - Milan

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2019-11-13
Primary Completion
2024-08-31
Completion
2024-08-31
FDA Drug
Yes

Countries

  • Germany
  • Italy

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03891576 on ClinicalTrials.gov