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

This study has been completed.
Sponsor:
Information provided by:
Pfizer
ClinicalTrials.gov Identifier:
NCT00092001
First received: September 21, 2004
Last updated: October 15, 2008
Last verified: October 2008
History of Changes

September 21, 2004
October 15, 2008
January 2005
March 2007   (final data collection date for primary outcome measure)
Overall confirmed objective response rate (ORR) [ Time Frame: From screening until at least 28 days beyond discontinuation of study treatment. ] [ Designated as safety issue: No ]
Not Provided
Complete list of historical versions of study NCT00092001 on ClinicalTrials.gov Archive Site
  • Progression-free survival (PFS) [ Time Frame: From screening until disease progression or discontinuation of study ] [ Designated as safety issue: No ]
  • Time to progression (TTP) [ Time Frame: From screening until disease progression or discontinuation of study ] [ Designated as safety issue: No ]
  • Duration of response (DR) [ Time Frame: From screening until disease progression or discontinuation of study ] [ Designated as safety issue: No ]
  • Overall survival (OS) [ Time Frame: From screening until disease progression or discontinuation of study ] [ Designated as safety issue: No ]
  • Probability of survival at 1 year [ Time Frame: From screening until disease progression or discontinuation of study ] [ Designated as safety issue: No ]
Not Provided
Not Provided
Not Provided
 
Study Of SU011248 In Patients With Metastatic Non-Small Cell Lung Cancer
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.
Not Provided
Interventional
Phase 2
Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Carcinoma, Non-Small-Cell Lung
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
Experimental: 1
Intervention: Drug: Sunitinib
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
111
March 2007
March 2007   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States,   Italy,   Spain
 
NCT00092001
A6181040
No
Director, Clinical Trial Disclosure Group, Pfizer Inc
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
October 2008

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