Study Of SU011248 In Patients With Metastatic Non-Small Cell Lung Cancer

October 15, 2008 updated by: Pfizer

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

The purpose of this study is to test whether SU011248 has activity and is safe in patients with metastatic non-small cell lung cancer (NSCLC) who have failed a platinum-containing regimen and docetaxel.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

111

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
      • Orbassano (Torino), Italy, 10043
        • Pfizer Investigational Site
  • Spain
      • Barcelona, Spain, 08025
        • Pfizer Investigational Site
    • Barcelona
      • Badalona, Barcelona, Spain, 08916
        • Pfizer Investigational Site
  • United States
    • Maryland
      • Baltimore, Maryland, United States, 21231-1000
        • Pfizer Investigational Site
    • Missouri
      • St. Louis, Missouri, United States, 63110
        • Pfizer Investigational Site
      • St. Louis, Missouri, United States, 63110-1094
        • Pfizer Investigational Site
      • St. Peters, Missouri, United States, 63376
        • Pfizer Investigational Site
    • North Carolina
      • Chapel Hill, North Carolina, United States, 27599-7600
        • Pfizer Investigational Site
      • Clinton, North Carolina, United States, 28382
        • Pfizer Investigational Site
      • Goldsboro, North Carolina, United States, 27534
        • Pfizer Investigational Site
      • Pollocksville, North Carolina, United States, 28573
        • Pfizer Investigational Site
      • Wilson, North Carolina, United States, 27893
        • Pfizer Investigational Site
    • Pennsylvania
      • Pittsburgh, Pennsylvania, United States, 15232
        • Pfizer Investigational Site
    • Virginia
      • Charlottesville, Virginia, United States, 22908
        • Pfizer Investigational Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 1
Drug: Sunitinib
Sunitinib 50 mg by oral capsule daily for 4 weeks in every 6 week cycle until progression or unacceptable toxicity.
Other Names:
  • Sutent, SU011248

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Overall confirmed objective response rate (ORR)
Time Frame: From screening until at least 28 days beyond discontinuation of study treatment.
From screening until at least 28 days beyond discontinuation of study treatment.

Secondary Outcome Measures

Outcome Measure
Time Frame
Progression-free survival (PFS)
Time Frame: From screening until disease progression or discontinuation of study
From screening until disease progression or discontinuation of study
Time to progression (TTP)
Time Frame: From screening until disease progression or discontinuation of study
From screening until disease progression or discontinuation of study
Duration of response (DR)
Time Frame: From screening until disease progression or discontinuation of study
From screening until disease progression or discontinuation of study
Overall survival (OS)
Time Frame: From screening until disease progression or discontinuation of study
From screening until disease progression or discontinuation of study
Probability of survival at 1 year
Time Frame: From screening until disease progression or discontinuation of study
From screening until disease progression or discontinuation of study

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Pfizer

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2005

Primary Completion (Actual)

March 1, 2007

Study Completion (Actual)

March 1, 2007

Study Registration Dates

First Submitted

September 21, 2004

First Submitted That Met QC Criteria

September 24, 2004

First Posted (Estimate)

September 27, 2004

Study Record Updates

Last Update Posted (Estimate)

October 16, 2008

Last Update Submitted That Met QC Criteria

October 15, 2008

Last Verified

October 1, 2008

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • A6181040

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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