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Pazopanib in Recurrent or Persistent Uterine Carcinosarcoma
NCT01247571Phase 2
Key facts
- Status
- Completed
- Start
- Jan 2011
- Primary completion
- Jan 2016
- Countries
- 1
- Sponsor
- National Cancer Institute
- Modality
- Small Molecules
- Drugs
- pazopanib
- Conditions
- uterine carcinosarcoma (UCS)
01
Overview
Phase 2, open-label, single-arm trial of pazopanib in uterine carcinosarcoma (UCS), sponsored by National Cancer Institute. Primary endpoints: Objective Tumor Response (Complete or Partial) at 6 months, Percentage of Participants With Progression-free Survival at 6 Months and 1 more. Started Jan 2011; status: completed.
02
Design
1 arm- Study design
- Non-randomizedOpen-label
Treatment (pazopanib hydrochloride)
Patients receive pazopanib hydrochloride PO QD.
03
Who it enrols
Patients with histologically confirmed persistent or recurrent uterine carcinosarcoma, measurable disease, GOG performance status 0-2, and one prior chemotherapeutic regimen. Excludes prior pazopanib, significant cardiovascular disease, and CNS disease.
04
Endpoints
Primary
Objective Tumor Response (Complete or Partial)
Percentage of Participants With Progression-free Survival at 6 Months
Number of Patients With Grade 3 or Higher Adverse Events
Secondary
Progression-free Survival
Overall Survival
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