- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00036257
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
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
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Florida
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Orlando, Florida, United States, 32806
- Cancer Centers of Florida
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New York
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Albany, New York, United States, 12208
- Albany Regional Cancer Center
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Texas
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Dallas, Texas, United States, 75246
- Mary Crowley Medical Research Center (US Oncology)
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Tyler, Texas, United States, 75702
- Tyler Cancer Center
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Washington
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Spokane, Washington, United States, 99218
- Cancer Care Northwest
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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:
- Relapsed or refractory chronic lymphocytic leukemia.
- Patients must have either intermediate or high risk chronic lymphocytic leukemia according to the Rai Staging System.
- Must have failed at least 1 prior chemotherapy regimen (at least 1 of which included fludarabine) for CLL.
- No prior therapy within 4 weeks prior to entering the study. Patients must have fully recovered from the acute effects of prior therapy.
- Platelet count = 75,000/mm3 , hemoglobin = 8 gm/dL.
- Expected remaining life span > or = three months.
- ECOG performance status 0 - 2.
- 18 years or of legal age.
- Male patients or non-pregnant and non-lactating female patients, who are either using adequate birth control, are surgically sterile or post-menopausal.
- Negative serum pregnancy test, if fertile female.
- Willingness and ability to sign an informed consent document.
Exclusion Criteria:
- Evidence of CNS involvement.
- Other active malignancy or history of treatment of any malignancy (excluding non-melanoma skin cancer) within the previous three years.
- Previous therapy with Campath.
- Patients with low-risk chronic lymphocytic leukemia according to the Rai Staging System.
- Concurrent immunotherapy.
- Concurrent use of steroids.
- Use of an investigational medication or device within 1 month of initiating study therapy.
- Patients who have had allogeneic bone marrow transplantation.
- Total serum bilirubin above the upper limit of normal; serum creatinine above the upper limit of normal.
- AST or ALT > 2.5 times the upper limit of normal.
- 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
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.
Clinical Trials on Chronic Lymphocytic Leukemia
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National Heart, Lung, and Blood Institute (NHLBI)Active, not recruitingLeukemia, Lymphocytic, Chronic, B-Cell | Chronic Lymphocytic Leukemia | Leukemia, Chronic Lymphatic | B-Cell Chronic Lymphocytic Leukemia | Leukemia, Lymphocytic, Chronic | B-Lymphocytic Leukemia, Chronic | Leukemia, Chronic Lymphocytic, B-Cell | Lymphocytic Leukemia, Chronic, B Cell | Lymphocytic Leukemia...United States
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National Cancer Institute (NCI)CompletedB-cell Chronic Lymphocytic Leukemia | Refractory Chronic Lymphocytic Leukemia | Stage I Chronic Lymphocytic Leukemia | Stage II Chronic Lymphocytic Leukemia | Stage III Chronic Lymphocytic Leukemia | Stage IV Chronic Lymphocytic LeukemiaUnited States
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National Cancer Institute (NCI)TerminatedRefractory Chronic Lymphocytic Leukemia | Stage I Chronic Lymphocytic Leukemia | Stage II Chronic Lymphocytic Leukemia | Stage III Chronic Lymphocytic Leukemia | Stage IV Chronic Lymphocytic LeukemiaUnited States
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Mayo ClinicNational Cancer Institute (NCI)CompletedB-cell Chronic Lymphocytic Leukemia | Refractory Chronic Lymphocytic Leukemia | Stage 0 Chronic Lymphocytic Leukemia | Stage I Chronic Lymphocytic Leukemia | Stage II Chronic Lymphocytic LeukemiaUnited States
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National Cancer Institute (NCI)CompletedB-cell Chronic Lymphocytic Leukemia | Stage I Chronic Lymphocytic Leukemia | Stage II Chronic Lymphocytic Leukemia | Stage III Chronic Lymphocytic Leukemia | Stage IV Chronic Lymphocytic LeukemiaUnited States
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National Cancer Institute (NCI)TerminatedLeukemia | B-cell Chronic Lymphocytic Leukemia | Prolymphocytic Leukemia | Refractory Chronic Lymphocytic Leukemia | Stage I Chronic Lymphocytic Leukemia | Stage II Chronic Lymphocytic Leukemia | Stage III Chronic Lymphocytic Leukemia | Stage IV Chronic Lymphocytic LeukemiaUnited States
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OHSU Knight Cancer InstituteOregon Health and Science UniversityCompletedRefractory Chronic Lymphocytic Leukemia | Stage I Chronic Lymphocytic Leukemia | Stage II Chronic Lymphocytic Leukemia | Stage III Chronic Lymphocytic Leukemia | Stage IV Chronic Lymphocytic LeukemiaUnited States
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Roswell Park Cancer InstituteNational Cancer Institute (NCI); Celgene CorporationTerminatedChronic Lymphocytic Leukemia | B-cell Chronic Lymphocytic Leukemia | Stage 0 Chronic Lymphocytic Leukemia | Stage I Chronic Lymphocytic Leukemia | Stage II Chronic Lymphocytic LeukemiaUnited States
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Roswell Park Cancer InstituteWithdrawnRefractory Chronic Lymphocytic Leukemia | Stage II Chronic Lymphocytic Leukemia | Stage III Chronic Lymphocytic Leukemia | Stage IV Chronic Lymphocytic Leukemia
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Mayo ClinicNational Cancer Institute (NCI)CompletedChronic Lymphocytic Leukemia | Stage III Small Lymphocytic Lymphoma | Stage IV Small Lymphocytic Lymphoma | Stage 0 Chronic Lymphocytic Leukemia | Stage I Chronic Lymphocytic Leukemia | Stage II Chronic Lymphocytic Leukemia | Stage I Small Lymphocytic Lymphoma | Stage III Chronic Lymphocytic Leukemia and other conditionsUnited States
Clinical Trials on CP-461
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Astellas Pharma IncOSI PharmaceuticalsCompleted
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Astellas Pharma IncOSI Pharmaceuticals; Cell PathwaysCompleted
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Astellas Pharma IncOSI Pharmaceuticals; Cell PathwaysTerminated
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Astellas Pharma IncOSI Pharmaceuticals; Cell PathwaysCompleted
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Astellas Pharma IncOSI PharmaceuticalsCompletedChronic Lymphocytic LeukemiaUnited States
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MyoKardia, Inc.CompletedNon-obstructive Hypertrophic CardiomyopathyUnited States
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MyoKardia, Inc.CompletedObstructive Hypertrophic CardiomyopathyUnited States, France, Germany, Czechia, Spain, Belgium, Denmark, Portugal, Netherlands, Israel, Poland, United Kingdom, Italy
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MyoKardia, Inc.CompletedHypertrophic CardiomyopathyUnited States
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MyoKardia, Inc.CompletedCardiomyopathy, Hypertrophic Obstructive | Left Ventricular Outflow Tract ObstructionUnited States
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Bristol-Myers SquibbCompletedHypertrophic CardiomyopathyUnited States