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Phase 2 Study Of SU011248 As Consolidation Therapy In Patients With Locally Advanced Or Metastatic Non-Small Cell Lung Cancer


Phase 2
18 Years
N/A
Not Enrolling
Both
Non-small Cell Lung Cancer

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Trial Information

Phase 2 Study Of SU011248 As Consolidation Therapy In Patients With Locally Advanced Or Metastatic Non-Small Cell Lung Cancer


Inclusion Criteria:



- Histologically proven NSCLC

- Stage IIIB (locally advanced with malignant effusion) or Stage IV disease

- No prior therapy for NSCLC

- Evidence of unidimensionally measurable disease

Exclusion Criteria:

- Previous treatment with systemic chemotherapy for lung cancer

- History of or known brain metastases

- NCI CTCAE Grade 3 hemorrhage within 4 weeks of starting study treatment

- Evidence of hemoptysis within 4 weeks of starting study treatment

- Serious acute or chronic illness or recent history of significant cardiac abnormality

- Previous treatment with anti-angiogenesis agents including thalidomide, or inhibitors
of EGFR and PDGFR

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

Proportion of Subjects Surviving at One Year

Outcome Description:

Proportion of those surviving at the end of one year from the first dose of study treatment. In the absence of confirmation of death, survival time was censored at the last date the subject was known to be alive. Patients lacking data beyond the day of first dose had their survival time censored at Day 1 of treatment.

Outcome Time Frame:

From start of treatment until 1 year or death

Safety Issue:

No

Principal Investigator

Pfizer CT.gov Call Center

Investigator Role:

Study Director

Investigator Affiliation:

Pfizer

Authority:

United States: Food and Drug Administration

Study ID:

A6181057

NCT ID:

NCT00113516

Start Date:

September 2005

Completion Date:

March 2009

Related Keywords:

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

Name

Location

Pfizer Investigational SiteBlendora, California  91740
Pfizer Investigational SiteCrestview Hills, Kentucky  41017
Pfizer Investigational SiteSpringfield, Illinois  62701-1014
Pfizer Investigational SiteHouston, Texas  77030
Pfizer Investigational SiteCarmel, Indiana  46032
Pfizer Investigational SiteKingston, Pennsylvania  18704-5535
Pfizer Investigational SiteBristol, Tennessee  37620
Pfizer Investigational SiteNewark, Delaware  19713