Clinical trial NCT00092001: Study Of SU011248 In Patients With Metastatic Non-Small Cell Lung Cancer
Official title: A Phase 2 Efficacy And Safety Study Of SU011248 In Patients With Metastatic Non-Small Cell Lung Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Carcinoma, Non-Small-Cell Lung
Keywords: Non-small cell lung cancer, carcinoma, sunitinib, Phase 2
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2004-09-27
Enrollment: 111
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Overall confirmed objective response rate (ORR)
timeFrame: From screening until at least 28 days beyond discontinuation of study treatment.
Secondary outcomes:
measure: Progression-free survival (PFS)
timeFrame: From screening until disease progression or discontinuation of study
measure: Time to progression (TTP)
timeFrame: From screening until disease progression or discontinuation of study
measure: Duration of response (DR)
timeFrame: From screening until disease progression or discontinuation of study
measure: Overall survival (OS)
timeFrame: From screening until disease progression or discontinuation of study
measure: Probability of survival at 1 year
timeFrame: From screening until disease progression or discontinuation of study
Other outcomes:
Locations:
city: Baltimore
country: United States
facility: Pfizer Investigational Site
state: Maryland
city: St. Louis
country: United States
facility: Pfizer Investigational Site
state: Missouri
city: St. Louis
country: United States
facility: Pfizer Investigational Site
state: Missouri
city: St. Peters
country: United States
facility: Pfizer Investigational Site
state: Missouri
city: Chapel Hill
country: United States
facility: Pfizer Investigational Site
state: North Carolina
city: Clinton
country: United States
facility: Pfizer Investigational Site
state: North Carolina
city: Goldsboro
country: United States
facility: Pfizer Investigational Site
state: North Carolina
city: Pollocksville
country: United States
facility: Pfizer Investigational Site
state: North Carolina
city: Wilson
country: United States
facility: Pfizer Investigational Site
state: North Carolina
city: Pittsburgh
country: United States
facility: Pfizer Investigational Site
state: Pennsylvania
city: Charlottesville
country: United States
facility: Pfizer Investigational Site
state: Virginia
city: Orbassano (Torino)
country: Italy
facility: Pfizer Investigational Site
city: Badalona
country: Spain
facility: Pfizer Investigational Site
state: Barcelona
city: Barcelona
country: Spain
facility: Pfizer Investigational Site
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References: