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

Tracking Information
First Received Date ^ICMJE	November 21, 2003
Last Updated Date	June 23, 2005
Start Date ^ICMJE	May 2001
Primary Completion Date
Current Primary Outcome Measures ^ICMJE
Original Primary Outcome Measures ^ICMJE
Change History	Complete list of historical versions of study NCT00073489 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE
Original Secondary Outcome Measures ^ICMJE

Descriptive Information
Brief Title ^ICMJE	A Pilot Study of OSI-461 in Patients With Chronic Lymphocytic Leukemia (CLL)
Official Title ^ICMJE	A Pilot Trial of OSI-461 in Patients With Chronic Lymphocytic Leukemia
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.
Study Phase	Phase II
Study Type ^ICMJE	Interventional
Study Design ^ICMJE	Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study
Condition ^ICMJE	Chronic Lymphocytic Leukemia
Intervention ^ICMJE	Drug: OSI-461
Study Arms / Comparison Groups
Publications *
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Completed
Enrollment ^ICMJE	23
Completion Date	December 2003
Primary Completion Date
Eligibility Criteria ^ICMJE	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.
Gender	Both
Ages	18 Years and older
Accepts Healthy Volunteers	No
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	United States

Administrative Information
NCT ID ^ICMJE	NCT00073489
Responsible Party
Study ID Numbers ^ICMJE	OSI-461-005
Study Sponsor ^ICMJE	OSI Pharmaceuticals
Collaborators ^ICMJE
Investigators ^ICMJE
Information Provided By	OSI Pharmaceuticals
Verification Date	July 2004
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP