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

Chronic Lymphocytic Leukemia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00073489
• Other study ID #: OSI-461-005
• Status: Completed
• Phase: Phase 2
• First received: November 21, 2003
• Last updated: October 14, 2011
• Start date: May 2001
• Est. completion date: December 2003

Study information

• Verified date: October 2011
• Source: Astellas Pharma Inc
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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

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.

Other known NCT identifiers

• NCT00036049

Recruitment information / eligibility

• Status: Completed
• Enrollment: 23
• Est. completion date: December 2003
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Chronic Lymphocytic Leukemia
• Leukemia
• Leukemia, Lymphocytic, Chronic, B-Cell
• Leukemia, Lymphoid

Intervention

Drug:
• OSI-461

Locations

Country	Name	City	State
United States	Rocky Mountain Cancer Centers	Aurora	Colorado
United States	Southwest Regional Cancer Center	Austin	Texas
United States	Iowa Oncology Associates	Cedar Rapids	Iowa
United States	Dayton Oncology/Hematology Consultants	Dayton	Ohio
United States	Willamette Valley Cancer Center	Eugene	Oregon
United States	Cancer Centers of the Carolinas	Greenville	South Carolina
United States	Florida Oncology Associates	Jacksonville	Florida
United States	Oncology/Hematology Associates of Kansas City	Kansas City	Missouri
United States	Ocala Oncology Center	Ocala	Florida
United States	Arizona Hematology & Oncology Associates	Phoenix	Arizona
United States	Oncology & Hematology Associates of Southwest Virginia	Roanoke	Virginia
United States	Hematology Oncology Associates of South Texas	San Antonio	Texas
United States	Cancer Care Northwest	Spokane	Washington
United States	Tyler Cancer Center	Tyler	Texas
United States	Piedmont Hem Onc Assoc, P.A.	Winston-Salem	North Carolina

Sponsors (2)

Lead Sponsor	Collaborator
Astellas Pharma Inc	OSI Pharmaceuticals

Country where clinical trial is conducted

United States,