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Safety Study of XL844 in Subjects With Chronic Lymphocytic Leukemia

This study has been terminated.
(Study closed due to slow enrollment)
Sponsor:
Information provided by:
Exelixis
ClinicalTrials.gov Identifier:
NCT00234481
First received: October 5, 2005
Last updated: June 2, 2008
Last verified: June 2008
History of Changes
  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 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:

U.S. FDA Resources

Further study details as provided by Exelixis:

  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
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
Exelixis
  More Information

No publications provided

ClinicalTrials.gov 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
Leukemia, Lymphocytic, Chronic, B-Cell
Leukemia, Lymphoid
Lymphoma
Neoplasms by Histologic Type
Neoplasms
 Leukemia, B-Cell
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases

ClinicalTrials.gov processed this record on June 17, 2013