Safety Study of XL844 in Subjects With Chronic Lymphocytic Leukemia

NCT ID: NCT00234481

Last Updated: 2008-06-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE1

Study Classification

INTERVENTIONAL

Brief Summary

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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.

Detailed Description

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Conditions

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Chronic Lymphocytic Leukemia Small Lymphocytic Lymphoma

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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XL844

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Exelixis

INDUSTRY

Sponsor Role lead

Locations

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City of Hope National Cancer Center

Duarte, California, United States

Site Status

UCSD Moores Cancer Center

San Diego, California, United States

Site Status

UT MD Anderson Cancer Center

Houston, Texas, United States

Site Status

Countries

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United States

Other Identifiers

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XL844-001

Identifier Type: -

Identifier Source: org_study_id