Abstract | BACKGROUND: PATIENTS AND METHODS: In this phase I dose-escalation study, we assessed the safety, efficacy, and pharmacokinetics of efatutazone and the recommended dose (RD) was determined in Japanese patients with metastatic solid tumors using a 3+3 design. RESULTS: A total of 13 patients were enrolled and received efatutazone at doses of 0.25 mg, 0.50 mg, and 0.75 mg bid for multiple 3-week cycles. No dose-limiting toxicities were observed, and the maximum tolerated dose was not reached. Partial response was confirmed in one patient and stable disease in three. Efatutazone exposure was almost dose-proportional. RD was determined to be 0.50 mg bid, corresponding to the RD in previous global phase I studies. CONCLUSION:
Efatutazone demonstrated acceptable toxicity and gave evidence of disease control in Japanese patients with metastatic solid tumors.
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Authors | Haruyasu Murakami, Akira Ono, Toshiaki Takahashi, Yusuke Onozawa, Takahiro Tsushima, Kentaro Yamazaki, Takahiro Jikoh, Narikazu Boku, Nobuyuki Yamamoto |
Journal | Anticancer research
(Anticancer Res)
Vol. 34
Issue 9
Pg. 5133-41
(Sep 2014)
ISSN: 1791-7530 [Electronic] Greece |
PMID | 25202104
(Publication Type: Clinical Trial, Phase I, Journal Article, Research Support, Non-U.S. Gov't)
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Copyright | Copyright© 2014 International Institute of Anticancer Research (Dr. John G. Delinassios), All rights reserved. |
Chemical References |
- Antineoplastic Agents
- Biomarkers
- PPAR gamma
- Thiazolidinediones
- efatutazone
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Topics |
- Administration, Oral
- Aged
- Antineoplastic Agents
(pharmacology, therapeutic use)
- Biomarkers
(metabolism)
- Female
- Humans
- Male
- Middle Aged
- Neoplasm Metastasis
- Neoplasms
(diagnosis, drug therapy, pathology)
- PPAR gamma
(agonists)
- Thiazolidinediones
(pharmacology, therapeutic use)
- Treatment Outcome
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