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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00073489
Recruitment Status : Completed
First Posted : November 25, 2003
Last Update Posted : October 17, 2011
Sponsor:
Collaborator:
OSI Pharmaceuticals
Information provided by (Responsible Party):
Astellas Pharma Inc

Study Description
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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
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Study Type : Interventional  (Clinical Trial)
Enrollment : 23 participants
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 2001
Actual Study Completion Date : December 2003

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Arms and Interventions
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Outcome Measures
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Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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
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To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00073489


Locations
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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
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Responsible Party: Astellas Pharma Inc
ClinicalTrials.gov Identifier: NCT00073489    
Obsolete Identifiers: NCT00036049
Other Study ID Numbers: OSI-461-005
First Posted: November 25, 2003    Key Record Dates
Last Update Posted: October 17, 2011
Last Verified: October 2011
Keywords provided by Astellas Pharma Inc:
chronic leukemia
leukemia
CLL
Additional relevant MeSH terms:
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Leukemia
Leukemia, Lymphoid
Leukemia, Lymphocytic, Chronic, B-Cell
Neoplasms by Histologic Type
Neoplasms
 Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Leukemia, B-Cell