Study of XL999 in Patients With Metastatic Colorectal Cancer

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

PHASE2

Total Enrollment

17 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-12-31

Study Completion Date

2007-02-28

Brief Summary

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This clinical study is being conducted at multiple sites to determine the activity, safety, and tolerability of XL999 when given weekly to patients with metastatic colorectal cancer (CRC). XL999 is a small molecule inhibitor of multiple kinases including VEGFR, PDGFR, FGFR, FLT-3, and Src, which are involved in tumor cell growth, formation of new blood vessels (angiogenesis), and metastasis.

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Detailed Description

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Conditions

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Colorectal Cancer

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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XL999

XL999 will be administered at 2.4 mg/kg as a 4-hour intravenous (IV) infusion. Subjects will receive XL999 infusions weekly for 8 weeks of treatment unless drug-related toxicity requires dosing delay. In the absence of progressive disease and unacceptable toxicity, subjects may receive XL999 treatment weekly for up to a year on this study. After 8 weeks, at the discretion of the investigator, one dose of four may be omitted for a subject's convenience.

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Males and females with histologically confirmed metastatic colorectal cancer
* Measurable disease according to Response Criteria for Solid Tumors (RECIST)
* At least 1 prior therapeutic regimen (chemotherapy or biologic)
* ECOG performance status of 0 or 1
* Life expectancy ≥3 months
* Adequate organ and marrow function
* No other malignancies within 5 years
* Signed informed consent

Exclusion Criteria

* Radiation to ≥25% of bone marrow within 30 days of XL999 treatment
* Treatment with systemic anticancer therapy within 30 days of XL999 treatment
* Subject has not recovered to ≤ grade 1 or to within 10% of baseline from adverse events due to other medications administered \>30 days prior to study enrollment
* History of or known brain metastases, current spinal cord compression, or carcinomatous meningitis
* Uncontrolled and/or intercurrent illness
* Pregnant or breastfeeding females
* Known HIV

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No