Study of XL999 in Patients With Non-small Cell Lung 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

9 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-12-31

Study Completion Date

2008-07-31

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 non-small cell lung cancer (NSCLC). 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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Non-small Cell Lung 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

• The Study Treatment Period, in which subjects received a once-weekly, 4-hour intravenous (IV) infusion of XL999 at 2.4 mg/kg as outpatients for 8 weeks. Treatment was to be stopped at the occurrence of disease progression or unacceptable toxicity.

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Males and females with histologically confirmed NSCLC
* Prior treatment with a platinum- or taxane containing regimen
* Stage IIIB with malignant effusion, stage IV or recurrent NSCLC that is not amenable to curative therapy (either surgery or radiation therapy)
* Measurable disease according to Response Criteria for Solid Tumors (RECIST)
* 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
* Use of any systemic anticancer therapy within 30 days of XL999 treatment
* More than 2 prior systemic cytotoxic chemotherapy regimens
* More than 1 prior agent targeted against VEGF or EGFR (eg, bevacizumab, erlotinib, or gefitinib)
* Subject has not recovered to ≤ grade 1 or to within 10% of baseline from adverse events due to other medications administered \>30 days before study enrollment
* Uncontrolled and/or intercurrent illness
* History of or known brain metastases, current spinal cord compression, or carcinomatous meningitis
* Pregnant or breastfeeding females
* Known HIV

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No