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

October 5, 2005
June 2, 2008
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Complete list of historical versions of study NCT00234481 on ClinicalTrials.gov Archive Site
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Safety Study of XL844 in Subjects With Chronic Lymphocytic Leukemia
A Phase 1 Dose-Escalation Study of the Safety, Pharmacokinetics, and Pharmacodynamics of XL844 Administered Orally to Subjects With Chronic Lymphocytic Leukemia

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.

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Interventional
Phase 1
Allocation: Non-Randomized
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Chronic Lymphocytic Leukemia
  • Small Lymphocytic Lymphoma
Drug: XL844
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
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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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00234481
XL844-001
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Exelixis
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Exelixis
June 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP