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A Phase 2 Efficacy And Safety Study Of SU011248 In Patients With Non-Small Cell Lung Cancer And Brain Metastases

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

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Trial Information

A Phase 2 Efficacy And Safety Study Of SU011248 In Patients With Non-Small Cell Lung Cancer And Brain Metastases

Inclusion Criteria:

- Patients with radiologically proven brain metastases secondary to non-small cell lung

- Received previous whole brain radiation therapy and none, 1 or 2 prior systemic
therapy for the treatment of advanced/metastatic non-small cell lung cancer

Exclusion Criteria:

- Patients with brainstem lesions, spinal cord compression. carcinomatous meningitis,
or leptomeningeal disease.

- Brain metastases >4 cm in any linear direction

- Intracranial or intratumoral hemorrhage

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:

Progression-Free Survival (PFS)

Outcome Description:

Time in weeks from start of study treatment to first documentation of objective tumor progression or death due to any cause. Since day of first dose of medication and day criteria for progression were met, were each counted as a full day, 1 day was added to each calculation. PFS calculated as (first event date minus date of first dose of study medication plus 1) divided by 7.02. Used 7.02 days because it equals(=) 365 days per year divided by 52 weeks per year. Tumor progression was determined from oncologic assessment data (where data meet the criteria for progressive disease [PD]).

Outcome Time Frame:

Baseline, Day 1 of Week 5, 9, 17, 25, 33, and 41 to tumor progression or death (up to 1 year)

Safety Issue:


Principal Investigator

Pfizer Call Center

Investigator Role:

Study Director

Investigator Affiliation:



United States: Food and Drug Administration

Study ID:




Start Date:

March 2007

Completion Date:

December 2009

Related Keywords:

  • Non-Small Cell Lung Cancer
  • brain metastases
  • Sunitinib
  • Phase 2
  • Carcinoma, Non-Small-Cell Lung
  • Lung Neoplasms
  • Neoplasm Metastasis
  • Brain Neoplasms



Pfizer Investigational SiteBronx, New York  10461
Pfizer Investigational SiteHouston, Texas  77030
Pfizer Investigational SiteClearwater, Florida  33761
Pfizer Investigational SiteColumbia, Missouri  65201
Pfizer Investigational SiteKingston, Pennsylvania  18704-5535
Pfizer Investigational SiteFarmington, Connecticut  06030-3805
Pfizer Investigational SiteLivingston, New Jersey  07039