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 range
18 Years
Sex
FEMALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Safety: Occurrence of grade ≥3 thrombocytopenia
Timeframe: 3 months
Trial details
NCT IDNCT03891576
SponsorMario Negri Institute for Pharmacological Research
. 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
. Patient with immunocompromised status
. Patient with known active hepatic disease
. Prior treatment with a known PARP inhibitor
. 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.