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Study of OSI-211 vs. Topotecan in Patients With Relapsed Epithelial Ovarian Cancer

Phase 2
Completed
Conditions
Ovarian Neoplasms
Registration Number
NCT00046800
Lead Sponsor
Astellas Pharma Inc
Brief Summary

The purpose of this study is to estimate the efficacy and safety of OSI-211 and topotecan in patients with relapsed epithelial ovarian cancer.

Detailed Description

Not available

Recruitment & Eligibility

Status
COMPLETED
Sex
Female
Target Recruitment
80
Inclusion Criteria
  • Confirmed relapsed ovarian cancer.
  • Measurable disease greater than or equal to 20 mm (or greater than or equal to 10 mm on spiral CT scan).
  • One or two prior regimens of chemotherapy. At least one regimen must have contained cisplatin or carboplatin.
  • At least three weeks since prior chemotherapy and recovery from any related toxicities.
  • At least four weeks since prior radiotherapy and recovery from any related toxicities.
Exclusion Criteria

Not provided

Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Primary Outcome Measures
NameTimeMethod
Secondary Outcome Measures
NameTimeMethod

Trial Locations

Locations (11)

NYU- Kaplan Comprehensive Cancer Center

🇺🇸

New York, New York, United States

The Sarah Cannon Cancer Center, Centennial Medical Center

🇺🇸

Nashville, Tennessee, United States

St Chad's Unit

🇬🇧

Birmingham, United Kingdom

Beatson Oncology Centre

🇬🇧

Glasgow, United Kingdom

Royal Surrey County Hospital

🇬🇧

Guildford, Surrey, United Kingdom

Royal Marsden NHS Trust

🇬🇧

London, United Kingdom

Northern Centre for Cancer Research, Newcastle General Hospital

🇬🇧

Newcastle-upon-Tyne, United Kingdom

Mount Vernon Hospital

🇬🇧

Northwood, Middlesex, United Kingdom

CRC Department of Medical Oncology

🇬🇧

Sutton Surrey, United Kingdom

Taunton & Somerset Hospital

🇬🇧

Taunton, United Kingdom

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NYU- Kaplan Comprehensive Cancer Center
🇺🇸New York, New York, United States

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