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Study of AG-013736 in Patients With Refractory Metastatic Renal Cell Cancer
This study is ongoing, but not recruiting participants.
First Received: January 23, 2006   Last Updated: June 12, 2009   History of Changes
Sponsored by: Pfizer
Information provided by: Pfizer
ClinicalTrials.gov Identifier: NCT00282048
  Purpose

To determine the activity and response rate of AG-013736 in patients with advanced and refractory renal cell cancer, (patients who also failed on sorafenib-based therapy).


Condition Intervention Phase
Kidney Neoplasms
Carcinoma, Renal Cell
Drug: AG-013736 (axitinib)
Phase II

Study Type: Interventional
Study Design: Treatment, Non-Randomized, Open Label, Single Group Assignment, Safety/Efficacy Study
Official Title: Phase 2 Study of AG-013736 in Patients With Refractory Metastatic Renal Cell Cancer

Resource links provided by NLM:


Further study details as provided by Pfizer:

Primary Outcome Measures:
  • Measured by overall objective response rate, CR and PR, by RECIST. [ Time Frame: 1/06-12/08 ] [ Designated as safety issue: No ]
  • To determine the activity and response rate of AG-013736 in patients with advanced and refractory renal cell cancer [ Time Frame: 1/06-12/08 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Progression-free survival [ Time Frame: 1/06-12/08 ] [ Designated as safety issue: No ]
  • Duration of response [ Time Frame: 1/06-12/08 ] [ Designated as safety issue: No ]
  • Explore effects of treatment on patient reported outcomes [ Time Frame: 1/06-12/08 ] [ Designated as safety issue: No ]
  • Cancer related symptoms (FKSI) [ Time Frame: 1/06-12/08 ] [ Designated as safety issue: No ]
  • Overall survival [ Time Frame: 1/06-12/08 ] [ Designated as safety issue: No ]
  • Explore PK correlates with response or adverse events. [ Time Frame: 1/06-12/08 ] [ Designated as safety issue: No ]
  • Safety profile of AG-013736 [ Time Frame: 1/06-12/08 ] [ Designated as safety issue: No ]

Estimated Enrollment: 62
Study Start Date: March 2006
Estimated Study Completion Date: September 2009
Primary Completion Date: February 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
single arm: Experimental
AG-013736 single agent in continuous dosing until disease progression or unacceptable toxicity
Drug: AG-013736 (axitinib)
AG-013736 5 mg bid continuous dosing in 28 day cycles.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00282048

Locations
United States, Illinois
Pfizer Investigational Site
Chicago, Illinois, United States, 60637
United States, New York
Pfizer Investigational Site
Bronx, New York, United States, 10466
United States, Ohio
Pfizer Investigational Site
Cleveland, Ohio, United States, 44195
United States, Pennsylvania
Pfizer Investigational Site
Philadelphia, Pennsylvania, United States, 19111-2497
United States, Wisconsin
Pfizer Investigational Site
Madison, Wisconsin, United States, 53792
Sponsors and Collaborators
Pfizer
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
  More Information

Additional Information:
No publications provided

Responsible Party: Pfizer Inc ( Director, Clinical Trial Disclosure Group )
Study ID Numbers: A4061023
Study First Received: January 23, 2006
Last Updated: June 12, 2009
ClinicalTrials.gov Identifier: NCT00282048     History of Changes
Health Authority: United States: Food and Drug Administration

Study placed in the following topic categories:
Urinary Tract Neoplasm
Kidney Cancer
Renal Cancer
Urologic Diseases
Kidney Neoplasms
Carcinoma, Renal Cell
Urogenital Neoplasms
Kidney Diseases
Urologic Neoplasms
Adenocarcinoma
Neoplasms, Glandular and Epithelial
Carcinoma

Additional relevant MeSH terms:
Neoplasms
Neoplasms by Site
Neoplasms by Histologic Type
Urologic Diseases
Kidney Neoplasms
Carcinoma, Renal Cell
Urogenital Neoplasms
Kidney Diseases
Urologic Neoplasms
Adenocarcinoma
Neoplasms, Glandular and Epithelial
Carcinoma

ClinicalTrials.gov processed this record on July 02, 2009