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Trial record 1 of 1 for:    NCT00092001
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Study Of SU011248 In Patients With Metastatic Non-Small Cell Lung Cancer

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ClinicalTrials.gov Identifier: NCT00092001
Recruitment Status : Completed
First Posted : September 27, 2004
Last Update Posted : October 16, 2008
Sponsor:
Information provided by:
Pfizer

Tracking Information
First Submitted Date  ICMJE September 21, 2004
First Posted Date  ICMJE September 27, 2004
Last Update Posted Date October 16, 2008
Study Start Date  ICMJE January 2005
Actual Primary Completion Date March 2007   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 21, 2007)
Overall confirmed objective response rate (ORR) [ Time Frame: From screening until at least 28 days beyond discontinuation of study treatment. ]
Original Primary Outcome Measures  ICMJE Not Provided
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: December 21, 2007)
  • Progression-free survival (PFS) [ Time Frame: From screening until disease progression or discontinuation of study ]
  • Time to progression (TTP) [ Time Frame: From screening until disease progression or discontinuation of study ]
  • Duration of response (DR) [ Time Frame: From screening until disease progression or discontinuation of study ]
  • Overall survival (OS) [ Time Frame: 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 ]
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Study Of SU011248 In Patients With Metastatic Non-Small Cell Lung Cancer
Official Title  ICMJE A Phase 2 Efficacy And Safety Study Of SU011248 In Patients With Metastatic Non-Small Cell Lung Cancer
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Carcinoma, Non-Small-Cell Lung
Intervention  ICMJE Drug: Sunitinib
Sunitinib 50 mg by oral capsule daily for 4 weeks in every 6 week cycle until progression or unacceptable toxicity.
Other Name: Sutent, SU011248
Study Arms  ICMJE Experimental: 1
Intervention: Drug: Sunitinib
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: June 14, 2006)
111
Original Enrollment  ICMJE Not Provided
Actual Study Completion Date  ICMJE March 2007
Actual Primary Completion Date March 2007   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Italy,   Spain,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00092001
Other Study ID Numbers  ICMJE A6181040
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Director, Clinical Trial Disclosure Group, Pfizer Inc
Study Sponsor  ICMJE Pfizer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Pfizer CT.gov Call Center Pfizer
PRS Account Pfizer
Verification Date October 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP