A Phase 2 Efficacy And Safety Study Of SU011248 In Patients With Metastatic Non-Small Cell Lung Cancer

Pfizer1 site in 1 country111 target enrollmentJanuary 2005

ConditionsCarcinoma, Non-Small-Cell Lung

InterventionsSunitinib

DrugsSunitinib

Overview

Phase: Phase 2
Intervention: Sunitinib
Conditions: Carcinoma, Non-Small-Cell Lung
Sponsor: Pfizer
Enrollment: 111
Locations: 1
Primary Endpoint: Overall confirmed objective response rate (ORR)
Status: Completed
Last Updated: 17 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

January 2005

End Date

March 2007

Last Updated

17 years ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

Pfizer

Eligibility 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

Arms & Interventions

1

Intervention: Sunitinib

Outcomes

Primary Outcomes

Overall confirmed objective response rate (ORR)

Time Frame: From screening until at least 28 days beyond discontinuation of study treatment.

Secondary Outcomes

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)