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A Randomized Study of Safety and Efficacy of Pazopanib and Gemcitabine in Persistent or Relapsed Ovarian Cancer
NCT01610206 · View on ClinicalTrials.gov ↗
Study Summary
Ovarian cancer is the leading cause of gynecologic cancer deaths, and the fifth most common cause of cancer deaths in women. While approximately 75% of patients with epithelial ovarian cancer will respond to first-line chemotherapy with platinum and paclitaxel, most patients with advanced stage epithelial ovarian cancer will experience disease recurrence. Pazopanib is a novel agent has recently been approved for the treatment of subjects with advanced renal cell carcinoma (RCC), and preclinical studies suggest it may be effective in other cancers such as ovarian cancer. Therefore, the purpose of this study is to test the efficacy and safety of a novel agent, pazopanib, as an adjunct to a standard treatment, gemcitabine, for recurrent or persistent ovarian cancer. This is an open label study in which subjects will be randomized 1:1 to receive 4 cycles of either gemcitabine, or gemcitabine with pazopanib. Gemcitabine will be administered as an IV infusion weekly on days 1 and 8 of a 21 day cycle. Subjects randomized to receive pazopanib will take 800 mg daily during the 21 day cycle. All subjects will be monitored for toxicity and other indicators of safety (labs, physical exams, vitals) at intervals throughout the treatment cycles. Subjects will be followed for up to 5 years following the conclusion of treatment to evaluate efficacy. The primary endpoints of the study are progression free survival and overall survival, which will be assessed at three years.
Conditions Studied
Interventions
- DRUG Gemcitabine
- DRUG pazopanib
Study Locations (8)
Virginia
- University of Virginia — Charlottesville
- Virginia Commonwealth University — Richmond
Maine
- Maine Medical Center (MMP Women's Health) — Scarborough
Maryland
- Johns Hopkins Sidney Kimmel Comprehensive Cancer Center — Baltimore
North Carolina
- Duke University — Durham
Oklahoma
- Stephenson Cancer Center University of Oklahoma Health Sciences Center — Oklahoma City
Texas
- MD Anderson — Houston
Wisconsin
- University of Wisconsin-Madison — Madison
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 148 participants |
| Start Date | 2012-09 |
| Est. Completion | 2020-12-31 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01610206
The ClinicalTrials.gov registry entry for NCT01610206 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 148 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Linda R Duska, which has 1 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
The record links to 3 conditions, with Ovarian Cancer appearing as the primary indexed condition, and to 2 interventions — of which Gemcitabine 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: NCT01610206 reports 8 study locations spanning 7 distinct geographic areas — top geographies include Virginia, Maine, Maryland. 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 NCT01610206 about?
NCT01610206 is a clinical study titled "A Randomized Study of Safety and Efficacy of Pazopanib and Gemcitabine in Persistent or Relapsed Ovarian Cancer". Ovarian cancer is the leading cause of gynecologic cancer deaths, and the fifth most common cause of cancer deaths in women. While approximately 75% of patients with epithelial ovarian cancer will respond to first-line chemotherapy with platinum and paclitaxel, most patients with advanced stage epit...
What is the current status of trial NCT01610206?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 148 participants. The study started on 2012-09. Estimated completion is 2020-12-31.
What conditions does trial NCT01610206 study?
This clinical trial studies the following conditions: Ovarian Cancer, Fallopian Tube Cancer, Peritoneal Cancer. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT01610206?
The interventions under investigation include: Gemcitabine (DRUG), pazopanib (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT01610206?
This trial is sponsored by Linda R Duska, which has 1 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT01610206 being conducted?
This trial has 8 study locations across Maine, Maryland, North Carolina, Oklahoma, Texas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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