NCT00092001CompletedPhase 2
A Phase 2 Efficacy And Safety Study Of SU011248 In Patients With Metastatic Non-Small Cell Lung Cancer
Conditions
Interventions
Drugs
Trial Snapshot
- Phase
- Phase 2
- Status
- Completed
- Sponsor
- Pfizer
- Enrollment
- 111
- Locations
- 1
- Primary Endpoint
- Overall confirmed objective response rate (ORR)
Study 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.
Study Design
- Study Type
- Interventional
- Allocation
- Non Randomized
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Experimental
Intervention: Sunitinib (Drug)
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)
Investigators
Study Sites (1)
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A Phase 2 Efficacy And Safety Study Of Su011248 In Patients With Non-Small Cell Lung Cancer And Brain Metastaseson-Small cell lung cancer and brain metastasesMedDRA version: 14.1Level: PTClassification code 10059515Term: Non-small cell lung cancer metastaticSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)EUCTR2006-004451-38-ESPfizer, S.L.U.60