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

Phase 2

Completed

• Conditions: Carcinoma, Non-Small-Cell Lung
• Interventions: Drug: Sunitinib

• 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

Study Timeline

• Study First Submitted: 2004-09-21
• Study First Submitted QC: 2004-09-24
• Study First Posted: 2004-09-27
• Study Start: 2005-01
• Primary Completion: 2007-03
• Study Completion: 2007-03
• Status Verified: 2008-10
• Last Update Submitted: 2008-10-15
• Last Update Posted: 2008-10-16

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

Trial Locations

Locations (1)

Pfizer Investigational Site; 🇪🇸 Barcelona, Spain