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.

Study Overview

• Status: Completed
• Conditions: Carcinoma, Non-Small-Cell Lung
• Intervention / Treatment: Drug: Sunitinib

• Study Type: Interventional
• Enrollment (Actual): 111
• Phase: Phase 2

Contacts and Locations

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

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

How is the study designed?

Design Details

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

Number of Arms

1

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)	From screening until at least 28 days beyond discontinuation of study treatment.

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Pfizer

Publications and helpful links

Helpful Links

• To obtain contact information for a study center near you, click here.

Study record dates

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: Non-small cell lung cancer, carcinoma, sunitinib, Phase 2
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Neoplasms; Lung Diseases; Neoplasms by Site; Respiratory Tract Neoplasms; Thoracic Neoplasms; Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Carcinoma, Non-Small-Cell Lung; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Antineoplastic Agents; Angiogenesis Inhibitors; Angiogenesis Modulating Agents; Growth Substances; Growth Inhibitors; Protein Kinase Inhibitors; Sunitinib
• Other Study ID Numbers: A6181040