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A Phase 2 Study of XL999 Administered Intravenously to Subjects With Non-Small-Cell Lung Cancer

Phase 2
18 Years
Not Enrolling
Non-small Cell Lung Cancer

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Trial Information

A Phase 2 Study of XL999 Administered Intravenously to Subjects With Non-Small-Cell Lung Cancer

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

- 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

Type of Study:


Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Response rate

Outcome Time Frame:

Inclusion until disease progression

Safety Issue:


Principal Investigator

Paul Woodard, MD

Investigator Role:

Study Director

Investigator Affiliation:

Exelixis, Inc.


United States: Food and Drug Administration

Study ID:




Start Date:

December 2005

Completion Date:

July 2008

Related Keywords:

  • Non-Small Cell Lung Cancer
  • Carcinoma, Non-Small-Cell Lung
  • Lung Neoplasms



Hematology-Oncology Associates of Rockland Nyack, New York  10956
Joliet Oncology-Hematology Associates, Ltd. Flossmoor, Illinois  60422
Hematology/Oncology Associates of the Treasure Coast Port St. Lucie, Florida  34952
Center for Oncology Research and Treatment, PA Dallas, Texas  75230