Study Of AG-013736 (Axitinib) As Second-Line Treatment In Patients With Metastatic Renal Cell Cancer (mRCC)
NCT00569946
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- 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.
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| 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 * |
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* 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:
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| 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 |
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| 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 | |||||||