Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.

COMPLETED Phase 2

A Study of Niraparib in Patients With Ovarian Cancer Who Have Received Three or Four Previous Chemotherapy Regimens

NCT02354586 · View on ClinicalTrials.gov ↗

Study Summary

This is a Phase 2, open-label, single arm study to evaluate the safety and efficacy of niraparib in ovarian cancer patients who have received three or four previous chemotherapy regimens. Niraparib is an orally active PARP inhibitor. Niraparib will be administered once daily continuously during a 28-day cycle. Health-related quality of life will be measured by Eastern Cooperative Oncology Group performance status (ECOG). Safety and tolerability will be assessed by clinical review of adverse events (AEs), physical examinations, electrocardiograms (ECGs), RECIST tumor assessments and safety laboratory values.

Interventions

  • DRUG Niraparib

Study Locations (20)

California

  • GSK Investigational Site — Burbank
  • GSK Investigational Site — Duarte
  • GSK Investigational Site — Los Angeles
  • GSK Investigational Site — Los Angeles
  • GSK Investigational Site — San Francisco
  • GSK Investigational Site — Santa Barbara
  • GSK Investigational Site — Stanford

Arizona

  • GSK Investigational Site — Chandler
  • GSK Investigational Site — Phoenix
  • GSK Investigational Site — Tucson

Florida

  • GSK Investigational Site — Tampa
  • GSK Investigational Site — West Palm Beach

Illinois

  • GSK Investigational Site — Chicago
  • GSK Investigational Site — Chicago

Indiana

  • GSK Investigational Site — Indianapolis
  • GSK Investigational Site — Indianapolis

Louisiana

  • GSK Investigational Site — Covington
  • GSK Investigational Site — New Orleans

Connecticut

  • GSK Investigational Site — New Haven

Georgia

  • GSK Investigational Site — Atlanta

Trial Details

FieldValue
Enrollment Target 463 participants
Start Date 2015-03-23
Est. Completion 2021-08-23
Phase Phase 2

Sponsor

Tesaro

8 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT02354586

The ClinicalTrials.gov registry entry for NCT02354586 describes a study currently listed as completed. It is categorized as Phase 2, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 463 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Tesaro, which has 8 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

The record links to 2 conditions, with Ovarian Cancer appearing as the primary indexed condition, and to 1 intervention — of which Niraparib is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT02354586 reports 20 study locations spanning 8 distinct geographic areas — top geographies include California, Arizona, Florida. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

Frequently Asked Questions

What is clinical trial NCT02354586 about?

NCT02354586 is a clinical study titled "A Study of Niraparib in Patients With Ovarian Cancer Who Have Received Three or Four Previous Chemotherapy Regimens". This is a Phase 2, open-label, single arm study to evaluate the safety and efficacy of niraparib in ovarian cancer patients who have received three or four previous chemotherapy regimens. Niraparib is an orally active PARP inhibitor. Niraparib will be administered once daily continuously during a 28...

What is the current status of trial NCT02354586?

This trial is currently completed. It is a Phase 2 study. The enrollment target is 463 participants. The study started on 2015-03-23. Estimated completion is 2021-08-23.

What conditions does trial NCT02354586 study?

This clinical trial studies the following conditions: Ovarian Cancer, Ovarian Neoplasms. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT02354586?

The interventions under investigation include: Niraparib (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT02354586?

This trial is sponsored by Tesaro, which has 8 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

Where is trial NCT02354586 being conducted?

This trial has 20 study locations across Arizona, California, Connecticut, Florida, Georgia. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial