A Phase II Study of Axitinib in Metastatic Non-clear Cell Renal Cell Carcinoma Patients Previously Treated With Temsirolimus
NCT01798446
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- Histologically or cytologically confirmation of RCC without a clear cell histologic component, e.g., papillary type, chromophobe type, medullary type or unclassified)
- Patients with stage IV or recurrent disease not amenable to surgery, radiotherapy, or combined modality therapy with curative intent
- Previous treatment with temsirolimus
- Measurable disease according to RECIST criteria
- Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1
- Age 18 years or older
- Adequate cardiac function
- Adequate bone marrow, hepatic, and renal function
- Hematology:
Neutrophil same or more than 1.5 x 10^9/L Platelet same or more than 75 x 10^9/L Hemoglobin same or more than 9 g/dL -Liver function tests: Total bilirubin same or less than 1.5 x upper limit normal (xULN) aspartate aminotransferase(AST), alanine aminotransferase (ALT) same or less than 2.5 xULN Alkaline phosphatase same or less than 2.5 xULN
-Renal function tests: Creatinine clearance same or more than 30 mL/min
- Life expectancy more than 3 months
- Signed and dated informed consent of document indicating that the patient (or legally acceptable representative) has been informed of all pertinent aspects of the trial prior to enrollment
- Clear cell type RCC
- Composed of mostly sarcomatoid carcinoma
- Collecting duct type RCC
- Diagnosis of any serious secondary malignancy within the last 2 years, except for
adequately treated basal cell or squamous cell carcinoma of skin, or in situ carcinoma
of cervix uteri
- Hypertension that cannot be controlled by medications (blood pressure 150/90 mmHg
despite optimal medical therapy)
- Pregnancy or breast feeding
- Other severe acute or chronic medical or psychiatric condition
- Prior treatment on sunitinib, sorafenib, pazopanib or bevacizumab
- Uncontrolled central nerve system (CNS) metastasis (brain and/or leptomeningeal
metastasis)
- Patients who require concomitant treatment with potent cytochrome P 3A4 ( CYP3A4)
inducers and inhibitors
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Descriptive Information | ||||
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Brief Title ICMJE | A Phase II Study of Axitinib in Metastatic Non-clear Cell Renal Cell Carcinoma Patients Previously Treated With Temsirolimus | |||
Official Title ICMJE | A Phase II Study of Axitinib in Metastatic Non-clear Cell Renal Cell Carcinoma Patients Previously Treated With Temsirolimus | |||
Brief Summary |
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Detailed Description |
Based on above, this clinical study is designed to examine efficacy and adverse events of axitinib for non-clear cell renal cell carcinoma. | |||
Study Type ICMJE | Interventional | |||
Study Phase ICMJE | Phase 2 | |||
Study Design ICMJE | Allocation: N/A Intervention Model: Single Group Assignment Masking: None (Open Label) Primary Purpose: Treatment | |||
Condition ICMJE |
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Intervention ICMJE | Drug: Axitinib
Axitinib 5mg twice will be orally administered daily with one cycle of 4 weeks. The package of axitinib must be opened right before the administration due to its photosensitivity. | |||
Study Arms ICMJE | Experimental: Axitinib
This is a single arm study. Axitinib arm is the only arm who receive axitinib. Intervention: Drug: Axitinib | |||
Publications * | Rini BI, Escudier B, Tomczak P, Kaprin A, Szczylik C, Hutson TE, Michaelson MD, Gorbunova VA, Gore ME, Rusakov IG, Negrier S, Ou YC, Castellano D, Lim HY, Uemura H, Tarazi J, Cella D, Chen C, Rosbrook B, Kim S, Motzer RJ. Comparative effectiveness of axitinib versus sorafenib in advanced renal cell carcinoma (AXIS): a randomised phase 3 trial. Lancet. 2011 Dec 3;378(9807):1931-9. doi: 10.1016/S0140-6736(11)61613-9. Epub 2011 Nov 4. Erratum in: Lancet. 2012 Nov 24;380(9856):1818. | |||
* 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 | 41 | |||
Original Estimated Enrollment ICMJE | Same as current | |||
Actual Study Completion Date ICMJE | December 2016 | |||
Actual Primary Completion Date | June 2015 (Final data collection date for primary outcome measure) | |||
Eligibility Criteria ICMJE | Inclusion Criteria:
Neutrophil same or more than 1.5 x 10^9/L Platelet same or more than 75 x 10^9/L Hemoglobin same or more than 9 g/dL -Liver function tests: Total bilirubin same or less than 1.5 x upper limit normal (xULN) aspartate aminotransferase(AST), alanine aminotransferase (ALT) same or less than 2.5 xULN Alkaline phosphatase same or less than 2.5 xULN -Renal function tests: Creatinine clearance same or more than 30 mL/min
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 | Korea, Republic of | |||
Removed Location Countries | ||||
Administrative Information | ||||
NCT Number ICMJE | NCT01798446 | |||
Other Study ID Numbers ICMJE | H-1301-124-461 SNUH_Axitinib_NCCRCC ( Other Identifier: SNUH ) | |||
Has Data Monitoring Committee | No | |||
U.S. FDA-regulated Product | Not Provided | |||
IPD Sharing Statement ICMJE | Not Provided | |||
Responsible Party | Se-Hoon Lee, Seoul National University Hospital | |||
Study Sponsor ICMJE | Seoul National University Hospital | |||
Collaborators ICMJE | Pfizer | |||
Investigators ICMJE |
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PRS Account | Seoul National University Hospital | |||
Verification Date | December 2020 | |||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |