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Safety Study of XL844 in Subjects With Chronic Lymphocytic Leukemia

Phase 1
Terminated
Conditions
Chronic Lymphocytic Leukemia
Small Lymphocytic Lymphoma
Registration Number
NCT00234481
Lead Sponsor
Exelixis
Brief Summary

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.

Detailed Description

Not available

Recruitment & Eligibility

Status
TERMINATED
Sex
All
Target Recruitment
Not specified
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

Study & Design

Study Type
INTERVENTIONAL
Study Design
SINGLE_GROUP
Primary Outcome Measures
NameTimeMethod
Secondary Outcome Measures
NameTimeMethod

Trial Locations

Locations (3)

UCSD Moores Cancer Center

🇺🇸

San Diego, California, United States

City of Hope National Cancer Center

🇺🇸

Duarte, California, United States

UT MD Anderson Cancer Center

🇺🇸

Houston, Texas, United States

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