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A Phase 1 Dose-Escalation Study of the Safety, Pharmacokinetics, and Pharmacodynamics of XL844 Administered Orally to Subjects With Chronic Lymphocytic Leukemia


Phase 1
18 Years
N/A
Not Enrolling
Both
Chronic Lymphocytic Leukemia, Small Lymphocytic Lymphoma

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Trial Information

A Phase 1 Dose-Escalation Study of the Safety, Pharmacokinetics, and Pharmacodynamics of XL844 Administered Orally to Subjects With Chronic Lymphocytic Leukemia


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

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Authority:

United States: Food and Drug Administration

Study ID:

XL844-001

NCT ID:

NCT00234481

Start Date:

Completion Date:

Related Keywords:

  • Chronic Lymphocytic Leukemia
  • Small Lymphocytic Lymphoma
  • Leukemia
  • Leukemia, Lymphocytic, Chronic, B-Cell
  • Leukemia, Lymphoid
  • Lymphoma

Name

Location

City of Hope National Cancer Center Duarte, California  91010
UT MD Anderson Cancer Center Houston, Texas  77030
UCSD Moores Cancer Center La Jolla, California  93093