A Study Evaluating Intermittent and Continuous OSI-906 and Weekly Paclitaxel in Patients With Recurrent Epithelial Ovarian Cancer (and Other Solid Tumors)
NCT00889382 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 152
Last updated 2024-11-20
Summary
This is a multi-center, randomized, open-label, phase 1/2 study of continuous weekly paclitaxel and escalating doses of intermittent or continuous OSI-906 in patients with recurrent/relapsed ovarian and other solid tumors.
Conditions
Interventions
- DRUG
-
OSI-906
Administered orally
- DRUG
-
Administered intravenously
Sponsors & Collaborators
-
Astellas Pharma Inc
lead INDUSTRY
Principal Investigators
-
Principal Investigator - Czech Republic · General Faculty Hospital, Charles University
-
Medical Director · Astellas Pharma Global Development
-
Principal Investigator - Italy · Instituto Europeo de Oncologia
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2009-08-05
- Primary Completion
- 2014-08-01
- Completion
- 2014-08-25
- FDA Drug
- Yes
Countries
- United States
- Australia
- Canada
- Czechia
- Italy
- Poland
- Romania
- Russia
- Switzerland
- United Kingdom
Study Locations
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