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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

Status
Terminated
Phases
Phase 1
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00234481
Enrollment
Unknown
Registered
2005-10-07
Start date
Unknown
Completion date
Unknown
Last updated
2008-06-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic Lymphocytic Leukemia, Small Lymphocytic Lymphoma

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.

Interventions

DRUGXL844

Sponsors

Exelixis
Lead SponsorINDUSTRY

Study design

Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026