Study of XL999 in Patients With Non-small Cell Lung Cancer

Symphony Evolution

Status and phase

Terminated

Phase 2

Conditions

Non-small Cell Lung Cancer

Treatments

Drug: XL999

Study type

Interventional

Funder types

Industry

Identifiers

NCT00277329

XL999-204

Details and patient eligibility

About

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.

Enrollment

9 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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