Safety Study of XL844 in Subjects With Chronic Lymphocytic Leukemia

This study has been terminated.
(Study closed due to slow enrollment)
Information provided by:
Exelixis Identifier:
First received: October 5, 2005
Last updated: June 2, 2008
Last verified: June 2008
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 1

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

Resource links provided by NLM:

Further study details as provided by Exelixis:


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

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00234481

United States, California
City of Hope National Cancer Center
Duarte, California, United States, 91010
UCSD Moores Cancer Center
San Diego, California, United States, 92093
United States, Texas
UT MD Anderson Cancer Center
Houston, Texas, United States, 77030
Sponsors and Collaborators
  More Information Identifier: NCT00234481     History of Changes
Other Study ID Numbers: XL844-001 
Study First Received: October 5, 2005
Last Updated: June 2, 2008
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Leukemia, Lymphocytic, Chronic, B-Cell
Leukemia, Lymphoid
Immune System Diseases
Immunoproliferative Disorders
Leukemia, B-Cell
Lymphatic Diseases
Lymphoproliferative Disorders
Neoplasms by Histologic Type processed this record on May 26, 2016