Study Of AG-013736 In Patients With Refractory Metastatic Renal Cell Cancer
NCT00282048
ABOUT THIS STUDY
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- 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.
- 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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Descriptive Information | ||||
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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 |
| |||
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 | 62 | |||
Original Enrollment ICMJE | 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:
Exclusion Criteria:
| |||
Sex/Gender ICMJE |
| |||
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 |
| |||
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 |