Study Of AG-013736 (Axitinib) As Second-Line Treatment In Patients With Metastatic Renal Cell Cancer (mRCC)
NCT00569946
ABOUT THIS STUDY
FOR MORE INFORMATION
Contact a representative by phone, email, or visiting the study website. Please see the references below:
Pfizer Clinical Trials Contact Center
1-800-718-1021
Adult Trials: 18+ Years
- Patients histologically diagnosed as metastatic renal cell cancer with a component of clear cell cancer.
- Patients who are refractory to cytokine therapy as 1st line.
- Patients who experienced nephrectomy.
- Patients with at least 1 target lesion, as defined by RECIST.
- Patients with no uncontrolled hypertension.
- Gastrointestinal abnormalities
- Current use or anticipated inability to avoid potent CYP3A4 inhibitors or CYP1A2/3A4
inducers.
- Active seizure disorder or evidence of brain metastases.
- Patients with hemoptysis.
NEED INFO?
Questions about a trial? Call or email to reach a Pfizer Clinical Trial Contact Center Representative
TRY A NEW SEARCH
Search for Clinical Trials by condition, keyword or trial number. Share your location or enter your city or zip code to find studies near you.
Based on your search, you may also be interested in
- New York, New York
- Toronto, Ontario
- Durham, North Carolina
| Descriptive Information | |||||||
|---|---|---|---|---|---|---|---|
| Brief Title ICMJE | Study Of AG-013736 (Axitinib) As Second-Line Treatment In Patients With Metastatic Renal Cell Cancer (mRCC) | ||||||
| Official Title ICMJE | PHASE 2 STUDY OF AG-013736 AS SECOND-LINE TREATMENT IN PATIENTS WITH METASTATIC RENAL CELL CANCER | ||||||
| Brief Summary | To investigate objective tumor response of AG-013736 for metastatic Renal Cell Cancer (mRCC) | ||||||
| Detailed Description | Not Provided | ||||||
| Study Type ICMJE | Interventional | ||||||
| Study Phase ICMJE | Phase 2 | ||||||
| Study Design ICMJE | Masking: None (Open Label) Primary Purpose: Treatment | ||||||
| Condition ICMJE | Carcinoma, Renal Cell | ||||||
| Intervention ICMJE | Drug: AG-013736
AG-013736 5 mg BID will be administered orally on continuous schedule. Cycle length is 28 days. If the drug is well tolerated at 5 mg BID, the dose of AG-013736 may be titrated to 7 mg BID and then to a maximum of 10 mg BID. Number of cycles: until progression or unacceptable toxicity develops. | ||||||
| Study Arms ICMJE | Experimental: AG-013736
Intervention: Drug: AG-013736 | ||||||
| Publications * |
| ||||||
* 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 | 64 | ||||||
| Original Estimated Enrollment ICMJE | 63 | ||||||
| Actual Study Completion Date ICMJE | October 30, 2012 | ||||||
| Actual Primary Completion Date | February 26, 2010 (Final data collection date for primary outcome measure) | ||||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
| ||||||
| Sex/Gender ICMJE |
| ||||||
| Ages ICMJE | 20 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 | Japan | ||||||
| Removed Location Countries | |||||||
| Administrative Information | |||||||
| NCT Number ICMJE | NCT00569946 | ||||||
| Other Study ID Numbers ICMJE | A4061035 | ||||||
| Has Data Monitoring Committee | No | ||||||
| U.S. FDA-regulated Product | Not Provided | ||||||
| IPD Sharing Statement ICMJE |
| ||||||
| Responsible Party | Pfizer | ||||||
| Study Sponsor ICMJE | Pfizer | ||||||
| Collaborators ICMJE | Not Provided | ||||||
| Investigators ICMJE |
| ||||||
| PRS Account | Pfizer | ||||||
| Verification Date | May 2019 | ||||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP | |||||||