A Pilot Study of OSI-461 in Patients With Chronic Lymphocytic Leukemia (CLL)
NCT ID: NCT00073489
Last Updated: 2011-10-17
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
23 participants
INTERVENTIONAL
2001-05-31
2003-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
SINGLE_GROUP
TREATMENT
NONE
Interventions
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OSI-461
Eligibility Criteria
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Inclusion Criteria
* No previous therapy for CLL.
* Expected remaining life span greater than or equal to six months.
* 18 years or older.
* Willingness and ability to sign an informed consent.
Exclusion Criteria
* History of other malignancy which could affect the diagnosis or assessment of OSI-461.
* Previous therapy for CLL.
* Use of an investigational medication or device within one month of initiating study therapy.
* Concurrent immunotherapy.
* Use of steroids at the time of enrollment (patients who require steroids after enrollment may remain on study).
* Any condition or any medication which may interfere with the conduct of the study.
* Serious uncontrolled intercurrent medical or psychiatric illness, including serious infection.
* Evidence of CNS involvement.
* Pregnant or nursing women.
18 Years
ALL
No
Sponsors
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OSI Pharmaceuticals
INDUSTRY
Astellas Pharma Inc
INDUSTRY
Responsible Party
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Locations
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Arizona Hematology & Oncology Associates
Phoenix, Arizona, United States
Rocky Mountain Cancer Centers
Aurora, Colorado, United States
Florida Oncology Associates
Jacksonville, Florida, United States
Ocala Oncology Center
Ocala, Florida, United States
Iowa Oncology Associates
Cedar Rapids, Iowa, United States
Oncology/Hematology Associates of Kansas City
Kansas City, Missouri, United States
Piedmont Hem Onc Assoc, P.A.
Winston-Salem, North Carolina, United States
Dayton Oncology/Hematology Consultants
Dayton, Ohio, United States
Willamette Valley Cancer Center
Eugene, Oregon, United States
Cancer Centers of the Carolinas
Greenville, South Carolina, United States
Southwest Regional Cancer Center
Austin, Texas, United States
Hematology Oncology Associates of South Texas
San Antonio, Texas, United States
Tyler Cancer Center
Tyler, Texas, United States
Oncology & Hematology Associates of Southwest Virginia
Roanoke, Virginia, United States
Cancer Care Northwest
Spokane, Washington, United States
Countries
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Other Identifiers
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OSI-461-005
Identifier Type: -
Identifier Source: org_study_id
NCT00036049
Identifier Type: -
Identifier Source: nct_alias