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

This study has been completed.
Sponsor:
Collaborators:
Cell Pathways
OSI Pharmaceuticals
Information provided by (Responsible Party):
Astellas Pharma Inc
ClinicalTrials.gov Identifier:
NCT00036257
First received: May 8, 2002
Last updated: October 14, 2011
Last verified: October 2011
  Purpose

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.


Condition Intervention Phase
Chronic Lymphocytic Leukemia
Drug: CP-461
Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Masking: Open Label
Primary Purpose: Treatment

Resource links provided by NLM:


Further study details as provided by Astellas Pharma Inc:

Estimated Enrollment: 15
Study Start Date: March 2002
Study Completion Date: April 2003
  Eligibility

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

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00036257

Locations
United States, Florida
Cancer Centers of Florida
Orlando, Florida, United States, 32806
United States, New York
Albany Regional Cancer Center
Albany, New York, United States, 12208
United States, Texas
Mary Crowley Medical Research Center (US Oncology)
Dallas, Texas, United States, 75246
Tyler Cancer Center
Tyler, Texas, United States, 75702
United States, Washington
Cancer Care Northwest
Spokane, Washington, United States, 99218
Sponsors and Collaborators
Astellas Pharma Inc
Cell Pathways
OSI Pharmaceuticals
  More Information

No publications provided

Responsible Party: Astellas Pharma Inc
ClinicalTrials.gov Identifier: NCT00036257     History of Changes
Other Study ID Numbers: OSI-461-010
Study First Received: May 8, 2002
Last Updated: October 14, 2011
Health Authority: United States: Food and Drug Administration

Keywords provided by Astellas Pharma Inc:
Chronic Lymphocytic 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 August 20, 2014