Clinical trial NCT00094107: Anti-Angiogenesis Agent AG-013736 In Patients With Metastatic Melanoma
Official title: Phase 2 Study Of The Anti-Angiogenesis Agent AG-013736 In Patients With Metastatic Melanoma
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Melanoma
Skin Neoplasms
Keywords: melanoma
antiangiogenesis
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: NON_RANDOMIZED
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 France. Patients having melanoma that has spread to other parts of the body (i.e., metastatic) are eligible to participate. Patients must have disease that has been treated with no more than 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 metastatic melanoma as shown by the number of patients in the study who experience significant and durable tumor shrinkage.


Eligibility criteria: Inclusion Criteria:

* Histologically documented melanoma with metastases
* No more than 1 prior systemic therapy for metastatic disease (prior adjuvant therapy with interferon does not count as prior therapy for metastatic disease)

Exclusion Criteria:

* History of hemoptysis (coughing up of blood)
* Brain metastases

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 147 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 147 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 147 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 147 weeks
measure: Plasma Concentrations of Soluble Proteins
timeFrame: Day 1 (pre-dose) and then every 8 weeks up to 147 weeks
Locations:
city: Orange
country: United States
facility: Pfizer Investigational Site
state: California
city: Miami Beach
country: United States
facility: Pfizer Investigational Site
state: Florida
city: Boston
country: United States
facility: Pfizer Investigational Site
state: Massachusetts
city: Boston
country: United States
facility: Pfizer Investigational Site
state: Massachusetts
city: Boston
country: United States
facility: Pfizer Investigational Site
state: Massachusetts
city: Clairton
country: United States
facility: Pfizer Investigational Site
state: Pennsylvania
city: Greensburg
country: United States
facility: Pfizer Investigational Site
state: Pennsylvania
city: Johnstown
country: United States
facility: Pfizer Investigational Site
state: Pennsylvania
city: Pittsburgh
country: United States
facility: Pfizer Investigational Site
state: Pennsylvania
city: Pittsburgh
country: United States
facility: Pfizer Investigational Site
state: Pennsylvania
city: Wexford
country: United States
facility: Pfizer Investigational Site
state: Pennsylvania
city: Paris Cedex 13
country: France
facility: Pfizer Investigational Site
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References: