Clinical trial NCT00094094: Anti-angiogenesis Agent AG-013736 in Patients With Advanced Non-Small Cell Lung Cancer
Official title: Phase 2 Study of the Anti-Angiogenesis Agent AG-013736 as Second- or Later- Line Treatment in Patients With Advanced Non-Small Cell Lung Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Lung Neoplasms
Carcinoma, Non-small Cell Lung
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2004-10-14
Enrollment: 32
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This is a Phase 2 study being conducted at multiple centers in the United States and Germany. Patients having non-small cell lung cancer that has spread to other parts of the body (i.e., metastatic) or is locally advanced (i.e., Stage IIIB with malignant pleural effusion) are eligible to participate. Patients must have disease that has been treated with at least 1 prior treatment for metastatic disease (prior adjuvant treatment for localized disease does not count as prior treatment for metastatic disease). The purpose of the study is to test whether the angiogenesis inhibitor AG-013736 is an effective treatment for advanced non-small cell lung cancer as shown by the number of patients in the study who experience significant and durable tumor shrinkage


Eligibility criteria: Inclusion Criteria:

* Histologically documented non-small cell lung cancer with metastases (Stage IV or recurrent disease) or locally advanced (Stage IIIB) with malignant pleural effusion.
* At least 1 prior systemic therapy for metastatic disease (Prior adjuvant therapy for localized disease does not count as a prior therapy for metastatic disease).

Exclusion Criteria:

* Central lung lesions involving major blood vessels (arteries or veins). (Central lesions that maintain the structural integrity of vessels have the potential to bleed if the tumor lesion undergoes necrosis. MRI or CT angiography should be used in any case where there is any question as to whether blood vessels are involved.)
* Patients with a history of Grade 2 or worse hemoptysis are not eligible. Patients with a history of Grade 1 hemoptysis within 30 days of entry are not eligible

Primary outcomes:
measure: Percentage of Participants With Objective Response (OR)
timeFrame: Baseline until the date of first documented progression or discontinuation from the study due to any cause, assessed every 8 weeks up to 98 weeks
Secondary outcomes:
measure: Progression-Free Survival (PFS)
timeFrame: Baseline until the date of first documented progression or death due to any cause, assessed every 8 weeks up to 98 weeks
measure: Duration of Response (DR)
timeFrame: Baseline until the date of first documented progression or discontinuation from the study due to any cause, assessed every 8 weeks up to 98 weeks
measure: Overall Survival (OS)
timeFrame: Baseline to death due to any cause or at least 1 year after the initial dose for the last treated participant
Other outcomes:
measure: Population Pharmacokinetics for Axitinib (AG-013736) Plasma Concentrations
timeFrame: Day 1 (pre-dose), Day 29, Day 57 and then every 8 weeks up to 98 weeks
measure: Plasma Concentrations of Soluble Proteins
timeFrame: Day 1 (pre-dose) and then every 8 weeks up to 98 weeks
Locations:
city: Irvine
country: United States
facility: Pfizer Investigational Site
state: California
city: Orange
country: United States
facility: Pfizer Investigational Site
state: California
city: Chicago
country: United States
facility: Pfizer Investigational Site
state: Illinois
city: Park Ridge
country: United States
facility: Pfizer Investigational Site
state: Illinois
city: Coon Rapids
country: United States
facility: Pfizer Investigational Site
state: Minnesota
city: Fridley
country: United States
facility: Pfizer Investigational Site
state: Minnesota
city: Robbinsdale
country: United States
facility: Pfizer Investigational Site
state: Minnesota
city: Charlotte
country: United States
facility: Pfizer Investigational Site
state: North Carolina
city: Nashville
country: United States
facility: Pfizer Investigational Site
state: Tennessee
city: Madison
country: United States
facility: Pfizer Investigational Site
state: Wisconsin
city: Gauting
country: Germany
facility: Pfizer Investigational Site
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References: