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Japanese Journal of Clinical Oncology Advance Access published online on September 25, 2009
Japanese Journal of Clinical Oncology, doi:10.1093/jjco/hyp120
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© 2009 The Author(s)
This is an Open Access article distributed under the terms of the Creative Commons Attribution Non-Commercial License (http://creativecommons.org/licenses/by-nc/2.0/uk/) which permits unrestricted non-commercial use, distribution, and reproduction in any medium, provided the original work is properly cited.

Phase I Clinical and Pharmacokinetic Study of RAD001 (Everolimus) Administered Daily to Japanese Patients with Advanced Solid Tumors

Isamu Okamoto1, Toshihiko Doi2, Atsushi Ohtsu2, Masaki Miyazaki1, Asuka Tsuya3, Katsutoshi Kurei4, Ken Kobayashi4 and Kazuhiko Nakagawa1

1 Department of Medical Oncology, Kinki University School of Medicine, Osaka
2 Division of Gastrointestinal Oncology/Digestive Endoscopy, National Cancer Center Hospital East, Chiba
3 Division of Thoracic Oncology, Shizuoka Cancer Center, Shizuoka
4 Novartis Pharma K.K., Tokyo, Japan

For reprints and all correspondence: Isamu Okamoto, Department of Medical Oncology, Kinki University School of Medicine, 377-2 Ohno-higashi, Osaka-Sayama, Osaka 589-8511, Japan. E-mail: chi-okamoto{at}dotd.med.kindai.ac.jp

Received July 8, 2009; accepted August 14, 2009

Objective: To determine the pharmacokinetics and safety of RAD001 (everolimus) in Japanese patients with advanced solid tumors.

Methods: An open-label, non-randomized, dose-escalation Phase I study of RAD001 administered continuously once daily in a 28-day cycle was performed. The study had a ‘3 + 3’ design, with three patients recruited to each of three successive cohorts treated with RAD001 at 2.5, 5.0 or 10.0 mg/day.

Results: The pharmacokinetics of RAD001 in Japanese patients were similar to those previously determined in Caucasians. The drug safety profile was consistent with that of a mammalian target of rapamycin inhibitor. No dose-limiting toxicities were observed. One patient with esophageal cancer and one with gastric cancer treated with RAD001 at 10 mg/day showed marked tumor responses.

Conclusions: Treatment of Japanese cancer patients with RAD001 may be undertaken with the expectation that previously determined pharmacokinetic and safety profiles apply. The drug may hold promise for treatment of esophageal and gastric cancer.

Key Words: Phase I study • pharmacokinetics • mTOR • RAD001 • everolimus


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