A Pilot Study of OSI-461 in Patients With Chronic Lymphocytic Leukemia (CLL)

Sponsor

Astellas Pharma Inc (Industry)

Overall Status

Completed

CT.gov ID

NCT00073489

Collaborator

OSI Pharmaceuticals (Industry)

Enrollment

Locations

Duration (Months)

1.5

Patients Per Site

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The objectives of this study are to evaluate the safety and efficacy of OSI-461 in CLL patients.

Condition or Disease	Intervention/Treatment	Phase
Chronic Lymphocytic Leukemia	Drug: OSI-461	Phase 2

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.

Study Design

Study Type:

Interventional

Allocation:

Non-Randomized

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

A Pilot Trial of OSI-461 in Patients With Chronic Lymphocytic Leukemia

Study Start Date :

May 1, 2001

Actual Study Completion Date :

Dec 1, 2003

Outcome Measures

Primary Outcome Measures

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
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
5	Iowa Oncology Associates	Cedar Rapids	Iowa	United States	52403
6	Oncology/Hematology Associates of Kansas City	Kansas City	Missouri	United States	64111
7	Piedmont Hem Onc Assoc, P.A.	Winston-Salem	North Carolina	United States	27103
8	Dayton Oncology/Hematology Consultants	Dayton	Ohio	United States	45439
9	Willamette Valley Cancer Center	Eugene	Oregon	United States	97401
10	Cancer Centers of the Carolinas	Greenville	South Carolina	United States	29615
11	Southwest Regional Cancer Center	Austin	Texas	United States	78705
12	Hematology Oncology Associates of South Texas	San Antonio	Texas	United States	78229
13	Tyler Cancer Center	Tyler	Texas	United States	75702
14	Oncology & Hematology Associates of Southwest Virginia	Roanoke	Virginia	United States	24101
15	Cancer Care Northwest	Spokane	Washington	United States	99202