Know Cancer

forgot password

Phase 2 Study of AG 013736 as Second-Line Treatment in Patients With Metastatic Renal Cell Cancer

Phase 2
18 Years
Not Enrolling
Kidney Neoplasms

Thank you

Trial Information

Phase 2 Study of AG 013736 as Second-Line Treatment in Patients With Metastatic Renal Cell Cancer

Inclusion Criteria:

- Histologically documented RCC with metastases.

- Failure of 1 prior cytokine-based therapy (interleukin-2 and/or interferon) due to
disease progression or unacceptable treatment-related toxicity

Exclusion Criteria:

- Any prior systemic treatment for Renal Cell Carcinoma [RCC] other than 1 prior
cytokine-based treatment regimen. Cytokine-based regimens containing thalidomide or
an anti-angiogenesis agent are not allowed.

- Inability to take oral medication

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 139 weeks

Safety Issue:


Principal Investigator

Pfizer Call Center

Investigator Role:

Study Director

Investigator Affiliation:



United States: Food and Drug Administration

Study ID:




Start Date:

October 2003

Completion Date:

February 2007

Related Keywords:

  • Kidney Neoplasms
  • Neoplasms
  • Kidney Neoplasms



Pfizer Investigational Site Blendora, California  91740
Pfizer Investigational Site Cincinnait, Ohio  45236
Pfizer Investigational Site Bronx, New York  10461
Pfizer Investigational Site North Adams, Massachusetts  01247
Pfizer Investigational Site Kingston, Pennsylvania  18704-5535
Pfizer Investigational Site Milwaukee, Wisconsin  53215