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
  Purpose

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 Intervention Phase
Carcinoma, Non-Small-Cell Lung
Drug: Sunitinib
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by Pfizer:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 111
Study Start Date: January 2005
Study Completion Date: March 2007
Primary Completion Date: March 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: Sutent, SU011248

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00092001

Locations
United States, Maryland
Pfizer Investigational Site
Baltimore, Maryland, United States, 21231-1000
United States, Missouri
Pfizer Investigational Site
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
United States, North Carolina
Pfizer Investigational Site
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
United States, Pennsylvania
Pfizer Investigational Site
Pittsburgh, Pennsylvania, United States, 15232
United States, Virginia
Pfizer Investigational Site
Charlottesville, Virginia, United States, 22908
Italy
Pfizer Investigational Site
Orbassano (Torino), Italy, 10043
Spain
Pfizer Investigational Site
Badalona, Barcelona, Spain, 08916
Pfizer Investigational Site
Barcelona, Spain, 08025
Sponsors and Collaborators
Pfizer
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
  More Information

Additional Information:
No publications provided

Responsible Party: Director, Clinical Trial Disclosure Group, Pfizer Inc
ClinicalTrials.gov Identifier: NCT00092001     History of Changes
Other Study ID Numbers: A6181040
Study First Received: September 21, 2004
Last Updated: October 15, 2008
Health Authority: United States: Food and Drug Administration

Keywords provided by Pfizer:
Non-small cell lung cancer, carcinoma, sunitinib, Phase 2

Additional relevant MeSH terms:
Carcinoma
Carcinoma, Non-Small-Cell Lung
Lung Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Carcinoma, Bronchogenic
Bronchial Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Lung Diseases
Respiratory Tract Diseases
Sunitinib
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Physiological Effects of Drugs
Growth Inhibitors

ClinicalTrials.gov processed this record on July 28, 2014