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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00277329
Recruitment Status : Terminated (Study was terminated due to cardiac toxicities in the subejcts)
First Posted : January 16, 2006
Last Update Posted : February 22, 2010
Information provided by:
Symphony Evolution, Inc.

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 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.

Condition or disease Intervention/treatment Phase
Non-small Cell Lung Cancer Drug: XL999 Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 9 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase 2 Study of XL999 Administered Intravenously to Subjects With Non-Small-Cell Lung Cancer
Study Start Date : December 2005
Actual Primary Completion Date : August 2007
Actual Study Completion Date : July 2008

Resource links provided by the National Library of Medicine

Intervention Details:
  • Drug: 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.

Primary Outcome Measures :
  1. Response rate [ Time Frame: Inclusion until disease progression ]
  2. Safety and tolerability [ Time Frame: Inclusion until 30 dyas post last treatment ]

Secondary Outcome Measures :
  1. Progression-free survival [ Time Frame: Inclusion until disease progression ]
  2. Duration of response [ Time Frame: Inclusion until disease progression ]
  3. Overall survival [ Time Frame: Inclusion until 180-Day Follow-up post last treatment or death ]
  4. Pharmacokinetic (PK) and Pharmacodynamic (PD) parameters [ Time Frame: Various time points during the 8-week Study Treatment Period in the second stage of the study ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00277329

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United States, Florida
Hematology/Oncology Associates of the Treasure Coast
Port St. Lucie, Florida, United States, 34952
United States, Illinois
Joliet Oncology-Hematology Associates, Ltd.
Joliet, Illinois, United States, 60435
United States, New York
Hematology-Oncology Associates of Rockland
Nyack, New York, United States, 10960
United States, Texas
Center for Oncology Research and Treatment, PA
Dallas, Texas, United States, 75230
Sponsors and Collaborators
Symphony Evolution, Inc.
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Study Director: Paul Woodard, MD Exelixis
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Responsible Party: Charles W. Finn, PhD, President and CEO, Symphony Evolution, Inc. Identifier: NCT00277329    
Other Study ID Numbers: XL999-204
First Posted: January 16, 2006    Key Record Dates
Last Update Posted: February 22, 2010
Last Verified: February 2010
Additional relevant MeSH terms:
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Lung Neoplasms
Carcinoma, Non-Small-Cell Lung
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Lung Diseases
Respiratory Tract Diseases
Carcinoma, Bronchogenic
Bronchial Neoplasms