Safety Study of XL844 in Subjects With Chronic Lymphocytic Leukemia
Phase 1
Terminated
- Conditions
- Chronic Lymphocytic LeukemiaSmall 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
Name Time Method
- Secondary Outcome Measures
Name Time Method
Related Research Topics
Explore scientific publications, clinical data analysis, treatment approaches, and expert-compiled information related to the mechanisms and outcomes of this trial. Click any topic for comprehensive research insights.
What are the molecular mechanisms by which XL844 inhibits MEK signaling in CLL and SLL patients?
How does the safety profile of XL844 compare to other MEK inhibitors like trametinib in treating refractory CLL/SLL?
Which biomarkers are associated with response to MEK inhibition in patients with chronic lymphocytic leukemia or small lymphocytic lymphoma?
What adverse events are commonly reported with oral MEK inhibitors in hematologic malignancies such as CLL?
Are there combination therapies involving XL844 and BTK inhibitors that show improved outcomes in relapsed/refractory CLL?
Trial Locations
- Locations (3)
City of Hope National Cancer Center
🇺🇸Duarte, California, United States
UCSD Moores Cancer Center
🇺🇸San Diego, California, United States
UT MD Anderson Cancer Center
🇺🇸Houston, Texas, United States
City of Hope National Cancer Center🇺🇸Duarte, California, United States