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

This study has been terminated.
(Study was terminated due to cardiac toxicities in the subejcts)
Sponsor:
Information provided by:
Symphony Evolution, Inc.
ClinicalTrials.gov Identifier:
NCT00277329
First received: January 12, 2006
Last updated: February 18, 2010
Last verified: February 2010
  Purpose

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 Intervention Phase
Non-small Cell Lung Cancer
Drug: XL999
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase 2 Study of XL999 Administered Intravenously to Subjects With Non-Small-Cell Lung Cancer

Resource links provided by NLM:


Further study details as provided by Symphony Evolution, Inc.:

Primary Outcome Measures:
  • Response rate [ Time Frame: Inclusion until disease progression ] [ Designated as safety issue: No ]
  • Safety and tolerability [ Time Frame: Inclusion until 30 dyas post last treatment ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Progression-free survival [ Time Frame: Inclusion until disease progression ] [ Designated as safety issue: No ]
  • Duration of response [ Time Frame: Inclusion until disease progression ] [ Designated as safety issue: No ]
  • Overall survival [ Time Frame: Inclusion until 180-Day Follow-up post last treatment or death ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: Yes ]

Enrollment: 9
Study Start Date: December 2005
Study Completion Date: July 2008
Primary Completion Date: August 2007 (Final data collection date for primary outcome measure)
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.
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00277329

Locations
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.
Investigators
Study Director: Paul Woodard, MD Exelixis, Inc
  More Information

No publications provided

Responsible Party: Charles W. Finn, PhD, President and CEO, Symphony Evolution, Inc.
ClinicalTrials.gov Identifier: NCT00277329     History of Changes
Other Study ID Numbers: XL999-204
Study First Received: January 12, 2006
Last Updated: February 18, 2010
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Carcinoma, Non-Small-Cell Lung
Lung Neoplasms
Carcinoma, Bronchogenic
Bronchial Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases

ClinicalTrials.gov processed this record on April 15, 2014