Newton Study (NEW Dosing MainTenance Therapy Ovarian CaNcer) (NCT03891576) | Clinical Trial Compass
TerminatedPhase 2
Newton Study (NEW Dosing MainTenance Therapy Ovarian CaNcer)
Stopped: Low accrual rate
Germany, Italy83 participantsStarted 2019-11-13
Plain-language summary
This study evaluates whether the adoption of the RADAR dosing strategy could further reduce treatment related toxicities improving the safety profile of niraparib.
Who can participate
Age range18 Years
SexFEMALE
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Inclusion criteria
✓. 18 years of age or older, female, any race
✓. Histologically diagnosed ovarian cancer, fallopian tube cancer or primary peritoneal cancer
✓. High grade (or grade 3) serous histology or known to have gBRCAmut
✓. Has received at least 2 previous lines of platinum-containing therapy (not necessarily consecutive), and has disease that was considered platinum sensitive following the penultimate platinum line (more than 6-months period between penultimate platinum regimen and progression of disease)
✓. Has responded to the last platinum line (PR or CR)
✓. No more than 8 weeks have elapsed from completion of the last platinum regimen and the patient is still not progressing after response
✓. Eastern Cooperative Oncology Group (ECOG) performance status of ≤ 1
✓. Adequate bone marrow, kidney and liver function, defined as follows:
Exclusion criteria
✕. Patient simultaneously enrolled in any interventional clinical trial
✕. Invasive cancer other than ovarian cancer within 2 years (except basal or squamous cell carcinoma of the skin that has been definitely treated)
✕. Patient with known, symptomatic brain or leptomeningeal metastases
✕
What they're measuring
1
Safety: Occurrence of grade ≥3 thrombocytopenia
Timeframe: 3 months
Trial details
NCT IDNCT03891576
SponsorMario Negri Institute for Pharmacological Research
✕. Patient who has had major surgery ≤ 3 weeks prior to initiating protocol therapy and participant must have recovered from any surgical effects.
✕. Patient who has received investigational therapy ≤ 4 weeks, or within a time interval less than at least 5 half-lives of the investigational agent, whichever is shorter, prior initiating protocol therapy.