Status:

TERMINATED

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

Lead Sponsor:

Symphony Evolution, Inc.

Conditions:

Non-small Cell Lung Cancer

Eligibility:

All Genders

18+ years

Phase:

PHASE2

Brief Summary

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 ...

Eligibility Criteria

Inclusion

  • 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

  • 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

Key Trial Info

Start Date :

December 1 2005

Trial Type :

INTERVENTIONAL

Allocation :

ACTUAL

End Date :

July 1 2008

Estimated Enrollment :

9 Patients enrolled

Trial Details

Trial ID

NCT00277329

Start Date

December 1 2005

End Date

July 1 2008

Last Update

February 22 2010

Active Locations (4)

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Page 1 of 1 (4 locations)

1

Hematology/Oncology Associates of the Treasure Coast

Port Saint Lucie, Florida, United States, 34952

2

Joliet Oncology-Hematology Associates, Ltd.

Joliet, Illinois, United States, 60435

3

Hematology-Oncology Associates of Rockland

Nyack, New York, United States, 10960

4

Center for Oncology Research and Treatment, PA

Dallas, Texas, United States, 75230