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

October 14, 2011 updated by: Astellas Pharma Inc

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment

23

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Astellas Pharma Inc

Collaborators

OSI Pharmaceuticals

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2001

Study Completion (Actual)

December 1, 2003

Study Registration Dates

First Submitted

November 21, 2003

First Submitted That Met QC Criteria

November 24, 2003

First Posted (Estimate)

November 25, 2003

Study Record Updates

Last Update Posted (Estimate)

October 17, 2011

Last Update Submitted That Met QC Criteria

October 14, 2011

Last Verified

October 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • OSI-461-005

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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