Carcinoma, Non-Small-Cell Lung
Conditions
Keywords
Non-small cell lung cancer, carcinoma, sunitinib, Phase 2
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.
Interventions
DRUGSunitinib
Sunitinib 50 mg by oral capsule daily for 4 weeks in every 6 week cycle until progression or unacceptable toxicity.
Sponsors
Pfizer
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Overall confirmed objective response rate (ORR) | From screening until at least 28 days beyond discontinuation of study treatment. |
Secondary
| 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 |
Countries
Italy, Spain, United States
Outcome results
None listed