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

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NCT00282048

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Study Location
Pfizer Investigational Site
Chicago, Illinois, 60637, United States
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Contact
1-800-718-1021
[email protected]
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Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Kidney Neoplasms, Carcinoma, Renal Cell
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18 + years
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- 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
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details


- 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.

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Kidney Neoplasms, Carcinoma, Renal CellStudy Of AG-013736 In Patients With Refractory Metastatic Renal Cell Cancer
NCT00282048
  1. Chicago, Illinois
  2. Bronx, New York
  3. Cleveland, Ohio
  4. Philadelphia, Pennsylvania
  5. Madison, Wisconsin
ALL GENDERS
18 Years+
years
MULTIPLE SITES
Advanced Information
Descriptive Information
Brief Title  ICMJE Study Of AG-013736 In Patients With Refractory Metastatic Renal Cell Cancer
Official Title  ICMJE Phase 2 Study Of AG-013736 In Patients With Refractory Metastatic Renal Cell Cancer
Brief Summary 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).
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Kidney Neoplasms
  • Carcinoma, Renal Cell
Intervention  ICMJE Drug: AG-013736 (axitinib)
AG-013736 5 mg twice daily [bid] continuous dosing in 28 day cycles.
Study Arms  ICMJE Experimental: AG-013736 (axitinib)
AG-013736 single agent in continuous dosing until disease progression or unacceptable toxicity
Intervention: Drug: AG-013736 (axitinib)
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: December 21, 2007)		62
Original Enrollment  ICMJE
 (submitted: January 23, 2006)		32
Actual Study Completion Date  ICMJE June 2009
Actual Primary Completion Date February 2009   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study:All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00282048
Other Study ID Numbers  ICMJE A4061023
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Pfizer
Study Sponsor  ICMJE Pfizer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director:Pfizer CT.gov Call CenterPfizer
PRS Account Pfizer
Verification Date July 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP