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

This study has been completed.

First Received on November 21, 2003. Last Updated on October 14, 2011 History of Changes

Sponsor:	Astellas Pharma Inc
Collaborator:	OSI Pharmaceuticals
Information provided by (Responsible Party):	Astellas Pharma Inc
ClinicalTrials.gov Identifier:	NCT00073489

Purpose

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

Condition	Intervention	Phase
Chronic Lymphocytic Leukemia	Drug: OSI-461	Phase II

Study Type:	Interventional
Study Design:	Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment
Official Title:	A Pilot Trial of OSI-461 in Patients With Chronic Lymphocytic Leukemia

Resource links provided by NLM:

MedlinePlus related topics: Acute Lymphocytic Leukemia Chronic Lymphocytic Leukemia Leukemia

Drug Information available for: CP 461

U.S. FDA Resources

Further study details as provided by Astellas Pharma Inc:

Estimated Enrollment:	23
Study Start Date:	May 2001
Study Completion Date:	December 2003

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.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00073489

Locations

United States, Arizona
Arizona Hematology & Oncology Associates
Phoenix, Arizona, United States, 85012
United States, Colorado
Rocky Mountain Cancer Centers
Aurora, Colorado, United States, 80012
United States, Florida
Florida Oncology Associates
Jacksonville, Florida, United States, 32207
Ocala Oncology Center
Ocala, Florida, United States, 34474
United States, Iowa
Iowa Oncology Associates
Cedar Rapids, Iowa, United States, 52403
United States, Missouri
Oncology/Hematology Associates of Kansas City
Kansas City, Missouri, United States, 64111
United States, North Carolina
Piedmont Hem Onc Assoc, P.A.
Winston-Salem, North Carolina, United States, 27103
United States, Ohio
Dayton Oncology/Hematology Consultants
Dayton, Ohio, United States, 45439
United States, Oregon
Willamette Valley Cancer Center
Eugene, Oregon, United States, 97401
United States, South Carolina
Cancer Centers of the Carolinas
Greenville, South Carolina, United States, 29615
United States, Texas
Southwest Regional Cancer Center
Austin, Texas, United States, 78705
Hematology Oncology Associates of South Texas
San Antonio, Texas, United States, 78229
Tyler Cancer Center
Tyler, Texas, United States, 75702
United States, Virginia
Oncology & Hematology Associates of Southwest Virginia
Roanoke, Virginia, United States, 24101
United States, Washington
Cancer Care Northwest
Spokane, Washington, United States, 99202

Sponsors and Collaborators

Astellas Pharma Inc

OSI Pharmaceuticals

More Information

No publications provided

Responsible Party:	Astellas Pharma Inc
ClinicalTrials.gov Identifier:	NCT00073489 History of Changes
Obsolete Identifiers:	NCT00036049
Other Study ID Numbers:	OSI-461-005
Study First Received:	November 21, 2003
Last Updated:	October 14, 2011
Health Authority:	United States: Food and Drug Administration

Keywords provided by Astellas Pharma Inc:

chronic leukemia
leukemia
CLL

Additional relevant MeSH terms:

Leukemia
Leukemia, Lymphocytic, Chronic, B-Cell
Leukemia, Lymphoid
Neoplasms by Histologic Type
Neoplasms

Leukemia, B-Cell
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases

ClinicalTrials.gov processed this record on February 09, 2012