Axitinib (AG-013736) With Or Without Dose Titration (Increase) In Patients With Kidney Cancer
NCT00835978
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- metastatic renal cell carcinoma (kidney cancer) with clear cell component
- no prior systemic therapy (including no prior adjuvant or neoadjuvant)
- Eastern Cooperative Oncology Group (ECOG) Performance Status 0-1
- Blood Pressure < or = 140/90mmHg
- brain/CNS metastasis
- using more than 2 blood pressure medications
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Descriptive Information | ||||
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Brief Title ICMJE | Axitinib (AG-013736) With Or Without Dose Titration (Increase) In Patients With Kidney Cancer | |||
Official Title ICMJE | Randomized, Double-blind Phase 2 Study Of Axitinib (Ag-013736) With Or Without Dose Titration In Patients With Metastatic Renal Cell Carcinoma | |||
Brief Summary | Axitinib dose titration (giving a higher dose of the drug above its standard starting dose) among certain patients may improve the response to treatment. | |||
Detailed Description | Not Provided | |||
Study Type ICMJE | Interventional | |||
Study Phase ICMJE | Phase 2 | |||
Study Design ICMJE | Allocation: Randomized Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) Primary Purpose: Treatment | |||
Condition ICMJE | Carcinoma, Renal Cell | |||
Intervention ICMJE |
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Study Arms ICMJE |
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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 | 213 | |||
Original Estimated Enrollment ICMJE | 200 | |||
Actual Study Completion Date ICMJE | February 2016 | |||
Actual Primary Completion Date | October 2012 (Final data collection date for primary outcome measure) | |||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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Sex/Gender ICMJE |
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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 | Czechia, Germany, Japan, Russian Federation, Spain, United States | |||
Removed Location Countries | Czech Republic | |||
Administrative Information | ||||
NCT Number ICMJE | NCT00835978 | |||
Other Study ID Numbers ICMJE | A4061046 2008-007786-23 ( EudraCT Number ) | |||
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 |
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PRS Account | Pfizer | |||
Verification Date | April 2017 | |||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |