Safety Study of XL844 in Subjects With Chronic Lymphocytic Leukemia - Full Text View

Sponsored by:	Exelixis
Information provided by:	Exelixis
ClinicalTrials.gov Identifier:	NCT00234481

Purpose

The purpose of this study is to assess the safety and tolerability of different doses of XL844 when given orally to adults with recurrent or refractory chronic lymphocytic leukemia or small lymphocytic lymphoma.

Condition	Intervention	Phase
Chronic Lymphocytic Leukemia Small Lymphocytic Lymphoma	Drug: XL844	Phase I

MedlinePlus related topics: Leukemia, Adult Acute Leukemia, Adult Chronic Lymphoma

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety Study
Official Title:	A Phase 1 Dose-Escalation Study of the Safety, Pharmacokinetics, and Pharmacodynamics of XL844 Administered Orally to Subjects With Chronic Lymphocytic Leukemia

Eligibility

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

Criteria

Inclusion Criteria:

Patients with recurrent or refractory chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL)
Prior treatment with at least 2 systemic chemotherapy regimens for CLL
Life expectancy of >3 months
Adequate liver and kidney function
Absolute neutrophil count ≥500/mm3; platelets ≥50,000/dL; hemoglobin ≥9 g/dL
Willing to use accepted method of contraception during the course of the study
Negative pregnancy test (females)
Written informed consent

Exclusion Criteria:

Chemotherapy or radiotherapy within 4-6 weeks of the start of treatment (depending on the therapy)
Investigational drug within 30 days of the start of treatment
Uncontrolled intercurrent illness such as infection or cardiovascular disease
Pregnant or breastfeeding women
Subjects known to be HIV positive

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00234481

Locations

United States, California
UCSD Moores Cancer Center
San Diego, California, United States, 92093
City of Hope National Cancer Center
Duarte, California, United States, 91010
United States, Texas
UT MD Anderson Cancer Center
Houston, Texas, United States, 77030

Sponsors and Collaborators

Exelixis

More Information

Study ID Numbers:	XL844-001
Study First Received:	October 5, 2005
Last Updated:	June 2, 2008
ClinicalTrials.gov Identifier:	NCT00234481
Health Authority:	United States: Food and Drug Administration

Study placed in the following topic categories:

Chronic lymphocytic leukemia
Lymphatic Diseases
Leukemia
Leukemia, Lymphoid
Immunoproliferative Disorders

Leukemia, Lymphocytic, Chronic, B-Cell
Leukemia, B-cell, chronic
Lymphoproliferative Disorders
Leukemia, B-Cell
Lymphoma

Additional relevant MeSH terms:

Neoplasms
Neoplasms by Histologic Type
Immune System Diseases

ClinicalTrials.gov processed this record on January 16, 2009