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NCT03326193 · ClinicalTrials.gov registry record · Phase 2
A Study of Niraparib Combined With Bevacizumab Maintenance Treatment in Participants With Advanced Ovarian Cancer Following Response on Front-Line Platinum-Based Chemotherapy
A Phase 2 study, sponsored by Tesaro.
- Completed
- Registry status
- Phase 2
- Development phase
- 105
- Enrollment target
NCT03326193 is a Phase 2 study that has completed, run by Tesaro. The registered enrollment target is 105 participants.
The verdict
NCT03326193, a Phase 2 study, has completed, sponsored by Tesaro.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 105 participants
- Enrollment target
Study Summary
Niraparib is an oral inhibitor of poly adenosine diphosphate-ribose polymerase (PARP)-1 and PARP-2. This study will evaluate safety and efficacy of niraparib combined with bevacizumab as maintenance treatment in participants with advanced (stage IIIB-IV) ovarian cancer, fallopian tube cancer, or primary peritoneal cancer following front-line platinum-based chemotherapy with bevacizumab. Eligible participants who achieve complete response (CR), partial response (PR), or no evidence of disease (NED) following treatment with platinum-based chemotherapy in addition to bevacizumab will be enrolled in the study and will receive maintenance treatment with niraparib (for up to 3 years) combined with bevacizumab (for up to 10 months during the maintenance phase or up to a total of 15 months inclusive of the approximately 5 months of bevacizumab received with chemotherapy) or until disease progression, unacceptable toxicity, participant withdrawal, Investigator's decision, or death, whichever comes first. Participants who have not progressed after 3 years of niraparib maintenance treatment may continue with niraparib beyond 3 years if they are benefiting from treatment, upon consultation with Sponsor.
Interventions
- BIOLOGICAL Bevacizumab
- DRUG Niraparib
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 105 participants |
| Start Date | 2017-12-12 |
| Est. Completion | 2024-07-12 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03326193
The ClinicalTrials.gov registry entry for NCT03326193 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 105 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Tesaro, which has 26 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Bevacizumab is the first listed.
NCT03326193 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT03326193 about?
NCT03326193 is a clinical study titled "A Study of Niraparib Combined With Bevacizumab Maintenance Treatment in Participants With Advanced Ovarian Cancer Following Response on Front-Line Platinum-Based Chemotherapy". Niraparib is an oral inhibitor of poly adenosine diphosphate-ribose polymerase (PARP)-1 and PARP-2. This study will evaluate safety and efficacy of niraparib combined with bevacizumab as maintenance treatment in participants with advanced (stage IIIB-IV) ovarian cancer, fallopian tube cancer, or pri...
What is the current status of trial NCT03326193?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 105 participants. The study started on 2017-12-12. Estimated completion is 2024-07-12.
What interventions are being tested in trial NCT03326193?
The interventions under investigation include: Bevacizumab (BIOLOGICAL), Niraparib (DRUG).
Who is sponsoring clinical trial NCT03326193?
This trial is sponsored by Tesaro, which has 26 total clinical trials registered on ClinicalTrials.gov.
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