Clinical trial NCT00073489: A Pilot Study of OSI-461 in Patients With Chronic Lymphocytic Leukemia (CLL)
Official title: A Pilot Trial of OSI-461 in Patients With Chronic Lymphocytic Leukemia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Chronic Lymphocytic Leukemia
Keywords: chronic leukemia
leukemia
CLL
Lead sponsor: Astellas Pharma Inc
Sponsor class: INDUSTRY
Collaborators: name: OSI Pharmaceuticals
First posted: 2003-11-25
Enrollment: 23
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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

Detailed 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.

Eligibility criteria: 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.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Phoenix
country: United States
facility: Arizona Hematology & Oncology Associates
state: Arizona
city: Aurora
country: United States
facility: Rocky Mountain Cancer Centers
state: Colorado
city: Jacksonville
country: United States
facility: Florida Oncology Associates
state: Florida
city: Ocala
country: United States
facility: Ocala Oncology Center
state: Florida
city: Cedar Rapids
country: United States
facility: Iowa Oncology Associates
state: Iowa
city: Kansas City
country: United States
facility: Oncology/Hematology Associates of Kansas City
state: Missouri
city: Winston-Salem
country: United States
facility: Piedmont Hem Onc Assoc, P.A.
state: North Carolina
city: Dayton
country: United States
facility: Dayton Oncology/Hematology Consultants
state: Ohio
city: Eugene
country: United States
facility: Willamette Valley Cancer Center
state: Oregon
city: Greenville
country: United States
facility: Cancer Centers of the Carolinas
state: South Carolina
city: Austin
country: United States
facility: Southwest Regional Cancer Center
state: Texas
city: San Antonio
country: United States
facility: Hematology Oncology Associates of South Texas
state: Texas
city: Tyler
country: United States
facility: Tyler Cancer Center
state: Texas
city: Roanoke
country: United States
facility: Oncology & Hematology Associates of Southwest Virginia
state: Virginia
city: Spokane
country: United States
facility: Cancer Care Northwest
state: Washington
Study officials:
References: