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Phase 2 Study Of AG-013736 In Patients With Refractory Metastatic Renal Cell Cancer


Phase 2
18 Years
N/A
Not Enrolling
Both
Kidney Neoplasms, Carcinoma, Renal Cell

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Trial Information

Phase 2 Study Of AG-013736 In Patients With Refractory Metastatic Renal Cell Cancer


Inclusion Criteria:



- RCC with metastases and nephrectomy

- failure of prior sorafenib-based therapy

- at least 1 target lesion that has not been irradiated

- adequate bone marrow, hepatic and renal function, > or equal to 18 years of age.

Exclusion Criteria:

- Gastrointestinal abnormalities

- current use or inability to avoid chronic antacid therapy

- current use or anticipated inability to avoid potent CYP3A4 inhibitors or CYP1A2
inducers

- active seizure disorder or evidence of brain metastases.

Type of Study:

Interventional

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 responses. 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 of longest dimensions.

Outcome Time Frame:

Baseline to disease progression or discontinuation from study due to any cause, assessed every 8 weeks up to 152 weeks

Safety Issue:

No

Principal Investigator

Pfizer CT.gov Call Center

Investigator Role:

Study Director

Investigator Affiliation:

Pfizer

Authority:

United States: Food and Drug Administration

Study ID:

A4061023

NCT ID:

NCT00282048

Start Date:

March 2006

Completion Date:

June 2009

Related Keywords:

  • Kidney Neoplasms
  • Carcinoma, Renal Cell
  • Neoplasms
  • Carcinoma
  • Carcinoma, Renal Cell
  • Kidney Neoplasms

Name

Location

Pfizer Investigational SiteCincinnait, Ohio  45236
Pfizer Investigational SiteSpringfield, Illinois  62701-1014
Pfizer Investigational SiteBronx, New York  10461
Pfizer Investigational SiteKingston, Pennsylvania  18704-5535
Pfizer Investigational SiteMilwaukee, Wisconsin  53215