• Haruko Daga, Toyoaki Hida, Shizu Ishikawa, Junichi Shimizu, Shinya Tokunaga, Yoshitsugu Horio, Ken Kobayashi, and Koji Takeda.
• Osaka City General Hospital, 2-13-22 Miyakojimahondori, Miyakojima-ku, Osaka 534-0021, Japan.
• Jpn. J. Clin. Oncol. 2011 Sep 1; 41 (9): 1067-73.

ObjectiveThis Phase I study was carried out to assess the safety, tolerability, pharmacokinetics and preliminary efficacy of the flavonoid tumor-vascular disrupting agent ASA404 (vadimezan) in combination with docetaxel in Japanese patients with advanced or recurrent solid tumors.MethodsNine Japanese patients were given ASA404 (1800 mg/m(2)) plus two doses of docetaxel, 60 or 75 mg/m(2), administered every 3 weeks.ResultsDose-limiting toxicity of Grade 3 febrile neutropenia was observed in one patient during Cycle 1 at Level 2 of ASA404 (1800 mg/m(2)) and docetaxel (75 mg/m(2)) treatment. The most frequently reported adverse events were neutropenia, fatigue, alopecia, decreased appetite, constipation and injection site pain. These adverse events were mainly Grade 1 or 2 in severity and, with the exception of injection site pain, were typically associated with docetaxel therapy. A partial response was observed in one patient, and five patients (55.6%) exhibited stable disease. Overall, the study demonstrated that ASA404 has an acceptable tolerability profile when combined with docetaxel at doses up to 75 mg/m(2) in Japanese patients with advanced solid tumors.ConclusionsThe study supports the enrollment of Japanese patients in the Phase III study (ATTRACT-2) of ASA404 in combination with docetaxel for the second-line treatment of advanced non-small cell lung cancer. Clinicaltrials.gov identifier: NCT01285453.

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