Status:
COMPLETED
A Pilot Study of OSI-461 in Patients With Chronic Lymphocytic Leukemia (CLL)
Lead Sponsor:
Astellas Pharma Inc
Collaborating Sponsors:
OSI Pharmaceuticals
Conditions:
Chronic Lymphocytic Leukemia
Eligibility:
All Genders
18+ years
Phase:
PHASE2
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 ...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 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.
Key Trial Info
Start Date :
May 1 2001
Trial Type :
INTERVENTIONAL
End Date :
December 1 2003
Estimated Enrollment :
23 Patients enrolled
Trial Details
Trial ID
NCT00073489
Start Date
May 1 2001
End Date
December 1 2003
Last Update
October 17 2011
Active Locations (15)
Enter a location and click search to find clinical trials sorted by distance.
1
Arizona Hematology & Oncology Associates
Phoenix, Arizona, United States, 85012
2
Rocky Mountain Cancer Centers
Aurora, Colorado, United States, 80012
3
Florida Oncology Associates
Jacksonville, Florida, United States, 32207
4
Ocala Oncology Center
Ocala, Florida, United States, 34474