A Pilot Study of OSI-461 in Patients With Chronic Lymphocytic Leukemia (CLL)
- Conditions
- Chronic Lymphocytic Leukemia
- Registration Number
- NCT00073489
- Lead Sponsor
- Astellas Pharma Inc
- Brief Summary
The objectives of this study are to evaluate the safety and efficacy of OSI-461 in CLL patients.
- Detailed Description
The primary objective of this study is to determine the activity of OSI-461 given twice daily orally in previously untreated CLL patients. The secondary objective is to evaluate the safety profile of OSI-461 in this patient population.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 23
- Diagnosis of CLL established by bone marrow aspiration and biopsy or flow cytometry of peripheral blood.
- 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.
- Other active malignancy or history of treatment of any malignancy (excluding non-melanoma skin cancer) within the previous three years.
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (15)
Tyler Cancer Center
🇺🇸Tyler, Texas, United States
Arizona Hematology & Oncology Associates
🇺🇸Phoenix, Arizona, United States
Oncology/Hematology Associates of Kansas City
🇺🇸Kansas City, Missouri, United States
Iowa Oncology Associates
🇺🇸Cedar Rapids, Iowa, United States
Florida Oncology Associates
🇺🇸Jacksonville, Florida, United States
Dayton Oncology/Hematology Consultants
🇺🇸Dayton, Ohio, United States
Willamette Valley Cancer Center
🇺🇸Eugene, Oregon, United States
Hematology Oncology Associates of South Texas
🇺🇸San Antonio, Texas, United States
Rocky Mountain Cancer Centers
🇺🇸Aurora, Colorado, United States
Southwest Regional Cancer Center
🇺🇸Austin, Texas, United States
Cancer Centers of the Carolinas
🇺🇸Greenville, South Carolina, United States
Cancer Care Northwest
🇺🇸Spokane, Washington, United States
Oncology & Hematology Associates of Southwest Virginia
🇺🇸Roanoke, Virginia, United States
Ocala Oncology Center
🇺🇸Ocala, Florida, United States
Piedmont Hem Onc Assoc, P.A.
🇺🇸Winston-Salem, North Carolina, United States