Study Of AG-013736 (Axitinib) As Second-Line Treatment In Patients With Metastatic Renal Cell Cancer (mRCC)
NCT ID: NCT00569946
Last Updated: 2019-06-05
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
64 participants
INTERVENTIONAL
2007-12-12
2012-10-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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TREATMENT
NONE
Study Groups
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AG-013736
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.
Interventions
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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.
Eligibility Criteria
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Inclusion Criteria
* 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.
Exclusion Criteria
* 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.
20 Years
ALL
No
Sponsors
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Pfizer
INDUSTRY
Responsible Party
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Principal Investigators
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Pfizer CT.gov Call Center
Role: STUDY_DIRECTOR
Pfizer
Locations
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National Cancer Center East Hospital
Kashiwa, Chiba, Japan
Hokkaido University Hospital
Sapporo, Hokkaido, Japan
Tsukuba University Hospital
Tsukuba, Ibaraki, Japan
Iwate Medical University
Morioka, Iwate, Japan
Kochi Medical School Hospital
Nankoku-shi, Kochi, Japan
Kinki University Hospital
Sayama, Osaka, Japan
Hamamatsu University School of Medicine University Hospital
Hamamatsu, Shizuoka, Japan
Shizuoka Cancer Center
Sunto-gun, Shizuoka, Japan
Tokyo Women's Medical University Medical Center East
Arakawa-ku, Tokyo, Japan
National Cancer Center
Chuo-ku, Tokyo, Japan
Nihon University Itabashi Hospital
Itabashi-ku, Tokyo, Japan
Akita University Hospital
Akita, , Japan
National Kyushu Cancer Center
Fukuoka, , Japan
Kyushu University Hospital, Department of Urology
Fukuoka, , Japan
University Hospital, Kyoto Prefectural University of Medicine
Kyoto, , Japan
Osaka University Hospital
Osaka, , Japan
Tokushima University Hospotal
Tokushima, , Japan
Yamagata University Hospital
Yamagata, , Japan
Countries
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References
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Schindler E, Amantea MA, Karlsson MO, Friberg LE. A Pharmacometric Framework for Axitinib Exposure, Efficacy, and Safety in Metastatic Renal Cell Carcinoma Patients. CPT Pharmacometrics Syst Pharmacol. 2017 Jun;6(6):373-382. doi: 10.1002/psp4.12193. Epub 2017 May 26.
Eto M, Uemura H, Tomita Y, Kanayama H, Shinohara N, Kamei Y, Fujii Y, Umeyama Y, Ozono S, Naito S, Akaza H; Japan Axitinib Phase II Study Group. Overall survival and final efficacy and safety results from a Japanese phase II study of axitinib in cytokine-refractory metastatic renal cell carcinoma. Cancer Sci. 2014 Dec;105(12):1576-83. doi: 10.1111/cas.12546. Epub 2014 Nov 25.
Tomita Y, Uemura H, Fujimoto H, Kanayama HO, Shinohara N, Nakazawa H, Imai K, Umeyama Y, Ozono S, Naito S, Akaza H; Japan Axitinib Phase II Study Group. Key predictive factors of axitinib (AG-013736)-induced proteinuria and efficacy: a phase II study in Japanese patients with cytokine-refractory metastatic renal cell Carcinoma. Eur J Cancer. 2011 Nov;47(17):2592-602. doi: 10.1016/j.ejca.2011.07.014. Epub 2011 Aug 31.
Related Links
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Other Identifiers
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A4061035
Identifier Type: -
Identifier Source: org_study_id
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