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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
N/A
Not Enrolling
Both
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
meningitis

- Known HIV

- Serious acute or chronic illness

- Current treatment on another clinical trial

- Pregnant or breastfeeding

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:

Overall confirmed objective response rate (ORR)

Outcome Time Frame:

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

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:

A6181040

NCT ID:

NCT00092001

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

Name

Location

Pfizer Investigational SiteRichmond, Virginia  23249
Pfizer Investigational SiteWestminster, Maryland  21157
Pfizer Investigational SiteColumbia, Missouri  65201
Pfizer Investigational SiteAsheville, North Carolina  28801
Pfizer Investigational SiteKingston, Pennsylvania  18704-5535