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

Sponsor
Pfizer (Industry)
Overall Status
Completed
CT.gov ID
NCT00092001
Collaborator
(none)
111
Enrollment
14
Locations
1
Arm
25.9
Duration (Months)
7.9
Patients Per Site
0.3
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease Intervention/Treatment Phase
Phase 2

Study Design

Study Type:
Interventional
Actual Enrollment :
111 participants
Allocation:
Non-Randomized
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
A Phase 2 Efficacy And Safety Study Of SU011248 In Patients With Metastatic Non-Small Cell Lung Cancer
Study Start Date :
Jan 1, 2005
Actual Primary Completion Date :
Mar 1, 2007
Actual Study Completion Date :
Mar 1, 2007

Arms and Interventions

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

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Overall confirmed objective response rate (ORR) [From screening until at least 28 days beyond discontinuation of study treatment.]

    Secondary Outcome Measures

    1. Progression-free survival (PFS) [From screening until disease progression or discontinuation of study]

    2. Time to progression (TTP) [From screening until disease progression or discontinuation of study]

    3. Duration of response (DR) [From screening until disease progression or discontinuation of study]

    4. Overall survival (OS) [From screening until disease progression or discontinuation of study]

    5. Probability of survival at 1 year [From screening until disease progression or discontinuation of study]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Pfizer Investigational Site Baltimore Maryland United States 21231-1000
    2 Pfizer Investigational Site St. Louis Missouri United States 63110-1094
    3 Pfizer Investigational Site St. Louis Missouri United States 63110
    4 Pfizer Investigational Site St. Peters Missouri United States 63376
    5 Pfizer Investigational Site Chapel Hill North Carolina United States 27599-7600
    6 Pfizer Investigational Site Clinton North Carolina United States 28382
    7 Pfizer Investigational Site Goldsboro North Carolina United States 27534
    8 Pfizer Investigational Site Pollocksville North Carolina United States 28573
    9 Pfizer Investigational Site Wilson North Carolina United States 27893
    10 Pfizer Investigational Site Pittsburgh Pennsylvania United States 15232
    11 Pfizer Investigational Site Charlottesville Virginia United States 22908
    12 Pfizer Investigational Site Orbassano (Torino) Italy 10043
    13 Pfizer Investigational Site Badalona Barcelona Spain 08916
    14 Pfizer Investigational Site Barcelona Spain 08025

    Sponsors and Collaborators

    • Pfizer

    Investigators

    • Study Director: Pfizer CT.gov Call Center, Pfizer

    Study Documents (Full-Text)

    None provided.

    More Information

    Additional Information:

    Publications

    None provided.
    Responsible Party:
    , ,
    ClinicalTrials.gov Identifier:
    NCT00092001
    Other Study ID Numbers:
    • A6181040
    First Posted:
    Sep 27, 2004
    Last Update Posted:
    Oct 16, 2008
    Last Verified:
    Oct 1, 2008
    Keywords provided by , ,
    Non-small cell lung cancer, carcinoma, sunitinib, Phase 2
    Additional relevant MeSH terms:
    Lung Neoplasms
    Carcinoma, Non-Small-Cell Lung
    Sunitinib

    Study Results

    No Results Posted as of Oct 16, 2008