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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00094107
Other study ID # A4061015
Secondary ID
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


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
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