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

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NCT00282048

Last updated on May 12, 2018
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FOR MORE INFORMATION
Study Location
Pfizer Investigational Site
Chicago, Illinois, 60637 United States
See other locations
Contact
1-800-718-1021
[email protected]
Related Links
Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Kidney Neoplasms, Renal Cell Carcinoma
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.

NCT00282048
Pfizer
Completed
Study Of AG-013736 In Patients With Refractory Metastatic Renal Cell Cancer

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Study Of AG-013736 In Patients With Refractory Metastatic Renal Cell Cancer
Phase 2 Study Of AG-013736 In Patients With Refractory Metastatic Renal Cell Cancer
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).
Not Provided
Interventional
Phase 2
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
  • Kidney Neoplasms
  • Carcinoma, Renal Cell
Drug: AG-013736 (axitinib)
AG-013736 5 mg twice daily [bid] continuous dosing in 28 day cycles.
Experimental: AG-013736 (axitinib)
AG-013736 single agent in continuous dosing until disease progression or unacceptable toxicity
Intervention: Drug: AG-013736 (axitinib)
Not Provided


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
62
June 2009
February 2009   (Final data collection date for primary outcome measure)

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.
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT00282048
A4061023
No
Not Provided
Not Provided
Pfizer
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
July 2012

ICMJE     Data element required by the

International Committee of Medical Journal Editors and the
World Health Organization ICTRP

FOR MORE INFORMATION

Contact a representative by phone, email, or visiting thte study website. To get updates and notications about this trail, sign up using the form below.

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1-800-718-1021

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[email protected]



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