Dose-Escalating and Safety Study of CP-461 in Patients With Chronic Lymphocytic Leukemia

October 14, 2011 updated by: Astellas Pharma Inc
The purposes of this study are to determine a maximum tolerated dose and to evaluate the safety and efficacy of CP-461 in patients with Chronic Lymphocytic Leukemia.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment

15

Phase

  • Phase 1

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
    • Florida
      • Orlando, Florida, United States, 32806
        • Cancer Centers of Florida
    • New York
      • Albany, New York, United States, 12208
        • Albany Regional Cancer Center
    • Texas
      • Dallas, Texas, United States, 75246
        • Mary Crowley Medical Research Center (US Oncology)
      • Tyler, Texas, United States, 75702
        • Tyler Cancer Center
    • Washington
      • Spokane, Washington, United States, 99218
        • 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:

  1. Relapsed or refractory chronic lymphocytic leukemia.
  2. Patients must have either intermediate or high risk chronic lymphocytic leukemia according to the Rai Staging System.
  3. Must have failed at least 1 prior chemotherapy regimen (at least 1 of which included fludarabine) for CLL.
  4. No prior therapy within 4 weeks prior to entering the study. Patients must have fully recovered from the acute effects of prior therapy.
  5. Platelet count = 75,000/mm3 , hemoglobin = 8 gm/dL.
  6. Expected remaining life span > or = three months.
  7. ECOG performance status 0 - 2.
  8. 18 years or of legal age.
  9. Male patients or non-pregnant and non-lactating female patients, who are either using adequate birth control, are surgically sterile or post-menopausal.
  10. Negative serum pregnancy test, if fertile female.
  11. Willingness and ability to sign an informed consent document.

Exclusion Criteria:

  1. Evidence of CNS involvement.
  2. Other active malignancy or history of treatment of any malignancy (excluding non-melanoma skin cancer) within the previous three years.
  3. Previous therapy with Campath.
  4. Patients with low-risk chronic lymphocytic leukemia according to the Rai Staging System.
  5. Concurrent immunotherapy.
  6. Concurrent use of steroids.
  7. Use of an investigational medication or device within 1 month of initiating study therapy.
  8. Patients who have had allogeneic bone marrow transplantation.
  9. Total serum bilirubin above the upper limit of normal; serum creatinine above the upper limit of normal.
  10. AST or ALT > 2.5 times the upper limit of normal.
  11. Any condition or any medication which may interfere with the conduct of the study.

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
  • 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
Cell Pathways

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

March 1, 2002

Study Completion (Actual)

April 1, 2003

Study Registration Dates

First Submitted

May 8, 2002

First Submitted That Met QC Criteria

May 8, 2002

First Posted (Estimate)

May 9, 2002

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-461-010

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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