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

Phase 2
18 Years
Not Enrolling
Melanoma, Skin Neoplasms

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Trial Information

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

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

Type of Study:


Study Design:

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

Outcome Measure:

Percentage of Participants With Objective Response (OR)

Outcome Description:

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.

Outcome Time Frame:

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

Safety Issue:


Principal Investigator

Pfizer Call Center

Investigator Role:

Study Director

Investigator Affiliation:



United States: Food and Drug Administration

Study ID:




Start Date:

December 2004

Completion Date:

April 2008

Related Keywords:

  • Melanoma
  • Skin Neoplasms
  • melanoma
  • antiangiogenesis
  • Neoplasms
  • Skin Neoplasms
  • Melanoma



Pfizer Investigational Site Blendora, California  91740
Pfizer Investigational Site Clearwater, Florida  33761
Pfizer Investigational Site North Adams, Massachusetts  01247
Pfizer Investigational Site Kingston, Pennsylvania  18704-5535