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

Phase 2
18 Years
Not Enrolling
Carcinoma, Non-Small-Cell Lung

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Trial Information

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

Inclusion Criteria:

- Histologically confirmed advanced or metastatic Non-Small Cell Lung Cancer that
cannot be cured with surgery, radiation, or combination thereof

- No more than 2 prior chemotherapy treatments including treatment with a platinum
containing therapy

- Evidence of measurable disease by radiographic technique

- Male or Female, 18 years or older

- ECOG performance status of 0 or 1

- Resolution of all acute toxicities of prior therapies

- Adequate organ function

Exclusion Criteria:

- Major surgery or radiation therapy within 4 weeks

- Severe hemorrhage within 4 weeks

- Previous treatment with anti-angiogenesis agents

- Diagnosis of second malignancy within last five 5 years

- History of or known brain metastases, spinal cord compression, or carcinomatous

- Known HIV

- Serious acute or chronic illness

- Current treatment on another clinical trial

- Pregnant or breastfeeding

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:

Overall confirmed objective response rate (ORR)

Outcome Time Frame:

From screening until at least 28 days beyond discontinuation of study treatment.

Safety Issue:


Principal Investigator

Pfizer Call Center

Investigator Role:

Study Director

Investigator Affiliation:



United States: Food and Drug Administration

Study ID:




Start Date:

January 2005

Completion Date:

March 2007

Related Keywords:

  • Carcinoma, Non-Small-Cell Lung
  • Non-small cell lung cancer, carcinoma, sunitinib, Phase 2
  • Carcinoma
  • Carcinoma, Non-Small-Cell Lung
  • Lung Neoplasms



Pfizer Investigational Site Richmond, Virginia  23249
Pfizer Investigational Site Westminster, Maryland  21157
Pfizer Investigational Site Columbia, Missouri  65201
Pfizer Investigational Site Asheville, North Carolina  28801
Pfizer Investigational Site Kingston, Pennsylvania  18704-5535