Newton Study (NEW Dosing MainTenance Therapy Ovarian CaNcer)

Sponsor
Mario Negri Institute for Pharmacological Research
Study ID
NCT03891576
Phase
PHASE2
Status
Terminated

Conditions

Eligibility Criteria

Sex
FEMALE
Age
18 Years - N/A
Healthy Volunteers
Accepted

Interventions

  • Niraparib — DRUG
    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.

Study Details

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

Key Dates

Start date
Nov 13, 2019
Status verified
Jan 2025
Primary completion
Aug 31, 2024
Completion
Aug 31, 2024

Study Design

Enrollment
83 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Niraparib 200 mg
    Niraparib will be administered every day as oral at a fixed dose of 200 mg
  • Active Comparator: Niraparib 300 mg
    Niraparib will be administered every day as oral at a fixed dose of 300 mg
  • Other: Niraparib 200mg/300mg
    Niraparib will be administered every day as oral at a fixed dose of 200 mg or 300 mg

Primary Outcome Measure

Safety: Occurrence of grade ≥3 thrombocytopenia [ Time Frame: 3 months ]

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