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

NCT00036257 | Completed Phase 1

• 1 other identifier: OSI-461-010
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 5

Brief Summary

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.

Conditions

Chronic Lymphocytic Leukemia

Keywords

Chronic Lymphocytic Leukemia; Leukemia; CLL

Interventions

CP-461 DRUG

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Astellas Pharma Inc: lead
• Cell Pathways: collaborator
• OSI Pharmaceuticals: collaborator

Study Sites (5)

Cancer Centers of Florida

Orlando, Florida, 32806, United States

Location

Albany Regional Cancer Center

Albany, New York, 12208, United States

Location

Mary Crowley Medical Research Center (US Oncology)

Dallas, Texas, 75246, United States

Location

Tyler Cancer Center

Tyler, Texas, 75702, United States

Location

Cancer Care Northwest

Spokane, Washington, 99218, United States

Location

MeSH Terms

Conditions

Leukemia, Lymphocytic, Chronic, B-Cell; Leukemia

Interventions

(5-fluoro-2-methyl-1-(4-pyridyl)methylene-3-(N-benzyl)-indene)-acetamide hydrochloride

Condition Hierarchy (Ancestors)

Leukemia, B-Cell; Leukemia, Lymphoid; Neoplasms by Histologic Type; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases; Lymphoproliferative Disorders; Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 8, 2002
• First Posted: May 9, 2002
• Study Start: March 1, 2002
• Study Completion: April 1, 2003
• Last Updated: October 17, 2011

Record last verified: 2011-10

Locations

US (5)