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Clinical Trials/NCT00234481
NCT00234481TerminatedPhase 1

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

Exelixis6 sites in 1 countryStarted: October 7, 2005Last updated:
Conditions
Drugs

Trial Snapshot

Phase
Phase 1
Status
Terminated
Sponsor
Exelixis
Locations
6

Study Overview

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.

Study Design

Study Type
Interventional
Allocation
Non Randomized
Intervention Model
Single Group
Primary Purpose
Treatment
Masking
None

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
Accepts 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

Investigators

Sponsor
Exelixis
Sponsor Class
Industry

Study Sites (6)

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