Back to resultsA Pilot Study of OSI-461 in Patients With Chronic Lymphocytic Leukemia (CLL)
Primary Purpose
Chronic Lymphocytic Leukemia
Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
OSI-461
Sponsored by
About this trial
This is an interventional treatment trial for Chronic Lymphocytic Leukemia focused on measuring chronic leukemia, leukemia, CLL
Eligibility Criteria
Inclusion Criteria: 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 Criteria: 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.
Sites / Locations
- Arizona Hematology & Oncology Associates
- Rocky Mountain Cancer Centers
- Florida Oncology Associates
- Ocala Oncology Center
- Iowa Oncology Associates
- Oncology/Hematology Associates of Kansas City
- Piedmont Hem Onc Assoc, P.A.
- Dayton Oncology/Hematology Consultants
- Willamette Valley Cancer Center
- Cancer Centers of the Carolinas
- Southwest Regional Cancer Center
- Hematology Oncology Associates of South Texas
- Tyler Cancer Center
- Oncology & Hematology Associates of Southwest Virginia
- Cancer Care Northwest
Outcomes
Primary Outcome Measures
Secondary Outcome Measures
Full Information
NCT ID
NCT00073489
First Posted
November 21, 2003
Last Updated
October 14, 2011
Sponsor
Astellas Pharma Inc
Collaborators
OSI Pharmaceuticals
1. Study Identification
Unique Protocol Identification Number
NCT00073489
Brief Title
A Pilot Study of OSI-461 in Patients With Chronic Lymphocytic Leukemia (CLL)
Official Title
A Pilot Trial of OSI-461 in Patients With Chronic Lymphocytic Leukemia
Study Type
Interventional
2. Study Status
Record Verification Date
October 2011
Overall Recruitment Status
Completed
Study Start Date
May 2001 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
December 2003 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Astellas Pharma Inc
Collaborators
OSI Pharmaceuticals
4. Oversight
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Lymphocytic Leukemia
Keywords
chronic leukemia, leukemia, CLL
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
23 (false)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
OSI-461
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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 Criteria:
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.
Facility Information:
Facility Name
Arizona Hematology & Oncology Associates
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85012
Country
United States
Facility Name
Rocky Mountain Cancer Centers
City
Aurora
State/Province
Colorado
ZIP/Postal Code
80012
Country
United States
Facility Name
Florida Oncology Associates
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32207
Country
United States
Facility Name
Ocala Oncology Center
City
Ocala
State/Province
Florida
ZIP/Postal Code
34474
Country
United States
Facility Name
Iowa Oncology Associates
City
Cedar Rapids
State/Province
Iowa
ZIP/Postal Code
52403
Country
United States
Facility Name
Oncology/Hematology Associates of Kansas City
City
Kansas City
State/Province
Missouri
ZIP/Postal Code
64111
Country
United States
Facility Name
Piedmont Hem Onc Assoc, P.A.
City
Winston-Salem
State/Province
North Carolina
ZIP/Postal Code
27103
Country
United States
Facility Name
Dayton Oncology/Hematology Consultants
City
Dayton
State/Province
Ohio
ZIP/Postal Code
45439
Country
United States
Facility Name
Willamette Valley Cancer Center
City
Eugene
State/Province
Oregon
ZIP/Postal Code
97401
Country
United States
Facility Name
Cancer Centers of the Carolinas
City
Greenville
State/Province
South Carolina
ZIP/Postal Code
29615
Country
United States
Facility Name
Southwest Regional Cancer Center
City
Austin
State/Province
Texas
ZIP/Postal Code
78705
Country
United States
Facility Name
Hematology Oncology Associates of South Texas
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78229
Country
United States
Facility Name
Tyler Cancer Center
City
Tyler
State/Province
Texas
ZIP/Postal Code
75702
Country
United States
Facility Name
Oncology & Hematology Associates of Southwest Virginia
City
Roanoke
State/Province
Virginia
ZIP/Postal Code
24101
Country
United States
Facility Name
Cancer Care Northwest
City
Spokane
State/Province
Washington
ZIP/Postal Code
99202
Country
United States
12. IPD Sharing Statement
Learn more about this trial
A Pilot Study of OSI-461 in Patients With Chronic Lymphocytic Leukemia (CLL)
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