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NCT04080284 · ClinicalTrials.gov registry record · Phase 2
Trial of Maintenance With Niraparib- Uterine Serous Carcinoma
A Phase 2 study of Endometrial Cancer and Endometrial Carcinoma, sponsored by Northwell Health.
- Completed
- Registry status
- Phase 2
- Development phase
- 22
- Enrollment target
- 6
- Study locations
NCT04080284: Completed Phase 2 study of Endometrial Cancer and Endometrial Carcinoma, sponsored by Northwell Health.
NCT04080284 is a Phase 2 study of Endometrial Cancer and Endometrial Carcinoma that has completed, run by Northwell Health. The registered enrollment target is 22 participants, below the 524-participant average among 181 other Endometrial Cancer trials with a reported enrollment target (96% lower). The trial reports 6 study locations across 2 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04080284, a Phase 2 study of Endometrial Cancer and Endometrial Carcinoma, has completed, sponsored by Northwell Health.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 22 participants
- Enrollment target
- 6
- Study locations
Study Summary
Uterine serous carcinoma (USC) accounts for up to 40% of endometrial cancer-related deaths. Patients with USC share many genomic and clinical characteristics with patients who has serous ovarian cancer. The objective of this study is to evaluate the efficacy of maintenance Niraparib regimen in patients with advanced or platinum sensitive recurrent uterine serous carcinoma. Additionally, the investigators aim to further describe the safety of this regimen. The investigators hypothesize that Niraparib maintenance will be a well-tolerated treatment and show significant response in patients with uterine serous carcinoma.
Primary Outcome
To determine the Progression Free Survival (PFS) at 1 year in the proposed Niraparib regimen in the population of patients with stage III, all stage IV, or recurrent uterine serous carcinoma (USC).
Conditions Studied
Interventions
- DRUG Niraparib
Study Locations (6)
New York
- Imbert Cancer Center Northwell Health - Bay Shore
- Greenlawn Cancer Institute, Northwell Health - Greenlawn
- RJ Zuckerberg Cancer Hospital - New Hyde Park
- Cancer Institute at Lenox Hill - New York
New Jersey
- Rutgers Cancer Institute of New Jersey - New Brunswick
- Rutgers NJ School of Medicine - Newark
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 22 participants |
| Start Date | 2019-12-30 |
| Est. Completion | 2025-01-01 |
| Phase | Phase 2 |
What the finished NCT04080284 record still lists
NCT04080284 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 22 participants, a relatively small participant target, below the 524-participant average among 181 other Endometrial Cancer trials with a reported enrollment target (96% lower).
The record links to 5 conditions, with Endometrial Cancer appearing as the primary indexed condition, and to 1 intervention - of which Niraparib is the first listed.
NCT04080284 lists 6 locations in 2 states (New York, New Jersey).
Frequently Asked Questions
What is clinical trial NCT04080284 about?
NCT04080284 is a clinical study titled "Trial of Maintenance With Niraparib- Uterine Serous Carcinoma". Uterine serous carcinoma (USC) accounts for up to 40% of endometrial cancer-related deaths. Patients with USC share many genomic and clinical characteristics with patients who has serous ovarian cancer. The objective of this study is to evaluate the efficacy of maintenance Niraparib regimen in patie...
What is the current status of trial NCT04080284?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 22 participants. The study started on 2019-12-30. Estimated completion is 2025-01-01.
What conditions does trial NCT04080284 study?
This clinical trial studies the following conditions: Endometrial Cancer, Endometrial Carcinoma, Uterine Serous Carcinoma, Cancer of the Endometrium, Papillary Serous Endometrial Carcinoma.
What interventions are being tested in trial NCT04080284?
The interventions under investigation include: Niraparib (DRUG).
Who is sponsoring clinical trial NCT04080284?
This trial is sponsored by Northwell Health, which has 370 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04080284 being conducted?
This trial has 6 study locations across New Jersey, New York. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Where NCT04080284's enrollment target sits among peer trials
22 165th of 181 higher than 17 of 181 other Endometrial Cancer trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Endometrial Cancer trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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