Anti-Angiogenesis Agent AG-013736 In Patients With Metastatic Melanoma

Melanoma Clinical Trial

Official title:

Phase 2 Study Of The Anti-Angiogenesis Agent AG-013736 In Patients With Metastatic Melanoma

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00094107
• Other study ID #: A4061015
• Status: Completed
• Phase: Phase 2
• First received: October 11, 2004
• Last updated: June 21, 2012
• Start date: December 2004
• Est. completion date: April 2008

Study information

• Verified date: June 2012
• Source: Pfizer
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 32
• Est. completion date: April 2008
• Est. primary completion date: April 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Melanoma
• Skin Neoplasms

Intervention

Drug:
• Axitinib [AG-013736]
VEGFR [vascular endothelial growth factor Receptor] and PDGFR [Platelet-Derived Growth Factor Receptor] inhibitor: Single agent AG-013736 starting dose 5 mg BID +/- 20% according to toxicity. Treatment until progression or unacceptable toxicity occurs.

Locations

Country	Name	City	State
France	Pfizer Investigational Site	Paris Cedex 13
United States	Pfizer Investigational Site	Boston	Massachusetts
United States	Pfizer Investigational Site	Boston	Massachusetts
United States	Pfizer Investigational Site	Boston	Massachusetts
United States	Pfizer Investigational Site	Clairton	Pennsylvania
United States	Pfizer Investigational Site	Greensburg	Pennsylvania
United States	Pfizer Investigational Site	Johnstown	Pennsylvania
United States	Pfizer Investigational Site	Miami Beach	Florida
United States	Pfizer Investigational Site	Orange	California
United States	Pfizer Investigational Site	Pittsburgh	Pennsylvania
United States	Pfizer Investigational Site	Pittsburgh	Pennsylvania
United States	Pfizer Investigational Site	Wexford	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
Pfizer

Countries where clinical trial is conducted

United States,  France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of Participants With Objective Response (OR)	Percentage of participants with OR based assessment of confirmed complete response (CR) or confirmed partial response (PR) according to Response Evaluation Criteria in Solid Tumors (RECIST). Confirmed responses are those that persist on repeat imaging study at least 4 weeks after initial documentation of response. CR are defined as the disappearance of all lesions (target and/or non target). PR are those with at least 30 percent (%) decrease in the sum of the longest dimensions of the target lesions taking as a reference the baseline sum longest dimensions.	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	No
Secondary	Progression-free Survival (PFS)	Time in days from start of study treatment to first documentation of objective tumor progression or death due to any cause. PFS was calculated as first event date minus the date of first dose of study medication plus 1. Tumor progression was determined from oncologic assessment data (where data meet the criteria for progressive disease [PD]), or from adverse event (AE) data (where the outcome was "Death").	Baseline until the date of first documented progression or death due to any cause, assessed every 8 weeks up to 147 weeks	No
Secondary	Duration of Response (DR)	Time in days from the first documentation of objective tumor response to objective tumor progression or death due to any cause. Duration of tumor response was calculated as the date of the first documentation of objective tumor progression or death due to cancer minus the date of the first CR or PR that was subsequently confirmed plus 1. DR was calculated for the subgroup of participants with a confirmed objective tumor response.	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	No
Secondary	Overall Survival (OS)	Time in days from the start of study treatment to date of death due to any cause. OS was calculated as the death date minus the date of first dose of study medication plus 1. Death was determined from AE data (where outcome was death) or from follow-up contact data (where the participant current status was death). For participants who were alive, overall survival was censored at the last contact.	Baseline to death due to any cause or at least 1 year after the initial dose for the last treated participant	No

External Links

•   To obtain contact information for a study center near you, click here.