Chronic Lymphocytic Leukemia Clinical Trial
Official title:
A Phase 1 Dose-Escalation Study of the Safety, Pharmacokinetics, and Pharmacodynamics of XL844 Administered Orally to Subjects With Chronic Lymphocytic Leukemia
| NCT number | NCT00234481 |
| Other study ID # | XL844-001 |
| Secondary ID | |
| Status | Terminated |
| Phase | Phase 1 |
| First received | October 5, 2005 |
| Last updated | June 2, 2008 |
| Verified date | June 2008 |
| Source | Exelixis |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | United States: Food and Drug Administration |
| Study type | Interventional |
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.
| Status | Terminated |
| Enrollment | 0 |
| Est. completion date | |
| Est. primary completion date | |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | 18 Years and older |
| Eligibility |
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 |
Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
| Country | Name | City | State |
|---|---|---|---|
| United States | City of Hope National Cancer Center | Duarte | California |
| United States | UT MD Anderson Cancer Center | Houston | Texas |
| United States | UCSD Moores Cancer Center | San Diego | California |
| Lead Sponsor | Collaborator |
|---|---|
| Exelixis |
United States,
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