Study Of SU011248 In Patients With Metastatic Non-Small Cell Lung Cancer
- Registration Number
- NCT00092001
- Lead Sponsor
- Pfizer
- 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 available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 111
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 & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description 1 Sunitinib -
- Primary Outcome Measures
Name Time Method Overall confirmed objective response rate (ORR) From screening until at least 28 days beyond discontinuation of study treatment.
- Secondary Outcome Measures
Name Time Method 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
Related Research Topics
Explore scientific publications, clinical data analysis, treatment approaches, and expert-compiled information related to the mechanisms and outcomes of this trial. Click any topic for comprehensive research insights.
What molecular mechanisms of Sunitinib (SU011248) are relevant to metastatic non-small cell lung cancer (NSCLC) treatment?
How does Sunitinib compare to standard-of-care therapies in platinum-resistant NSCLC patients?
Are there specific biomarkers associated with Sunitinib response in NSCLC with prior docetaxel failure?
What adverse events were observed in Phase 2 trials of Sunitinib for metastatic NSCLC and how were they managed?
What combination therapies involving Sunitinib have been explored for NSCLC treatment post-Pfizer NCT00092001 trial?
Trial Locations
- Locations (1)
Pfizer Investigational Site
🇪🇸Barcelona, Spain
Pfizer Investigational Site🇪🇸Barcelona, Spain