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Safety Study of XL844 in Subjects With Chronic Lymphocytic Leukemia

Primary Purpose

Chronic Lymphocytic Leukemia, Small Lymphocytic Lymphoma

Status
Terminated
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
XL844
Sponsored by
Exelixis
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Lymphocytic Leukemia

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • City of Hope National Cancer Center
  • UCSD Moores Cancer Center
  • UT MD Anderson Cancer Center

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
October 5, 2005
Last Updated
June 2, 2008
Sponsor
Exelixis
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1. Study Identification

Unique Protocol Identification Number
NCT00234481
Brief Title
Safety Study of XL844 in Subjects With Chronic Lymphocytic Leukemia
Official Title
A Phase 1 Dose-Escalation Study of the Safety, Pharmacokinetics, and Pharmacodynamics of XL844 Administered Orally to Subjects With Chronic Lymphocytic Leukemia
Study Type
Interventional

2. Study Status

Record Verification Date
June 2008
Overall Recruitment Status
Terminated
Why Stopped
Study closed due to slow enrollment
Study Start Date
undefined (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
Exelixis

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Lymphocytic Leukemia, Small Lymphocytic Lymphoma

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
XL844

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
City of Hope National Cancer Center
City
Duarte
State/Province
California
ZIP/Postal Code
91010
Country
United States
Facility Name
UCSD Moores Cancer Center
City
San Diego
State/Province
California
ZIP/Postal Code
92093
Country
United States
Facility Name
UT MD Anderson Cancer Center
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States

12. IPD Sharing Statement

Learn more about this trial

Safety Study of XL844 in Subjects With Chronic Lymphocytic Leukemia

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