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Phase I study of Efatutazone, an oral PPARγ agonist, in patients with metastatic solid tumors.

AbstractBACKGROUND:
Efatutazone is a highly selective agonist of peroxisome proliferator-activated receptor gamma (PPARγ), a therapeutic target for carcinogenesis.
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.
AuthorsHaruyasu Murakami, Akira Ono, Toshiaki Takahashi, Yusuke Onozawa, Takahiro Tsushima, Kentaro Yamazaki, Takahiro Jikoh, Narikazu Boku, Nobuyuki Yamamoto
JournalAnticancer research (Anticancer Res) Vol. 34 Issue 9 Pg. 5133-41 (Sep 2014) ISSN: 1791-7530 [Electronic] Greece
PMID25202104 (Publication Type: Clinical Trial, Phase I, Journal Article, Research Support, Non-U.S. Gov't)
CopyrightCopyright© 2014 International Institute of Anticancer Research (Dr. John G. Delinassios), All rights reserved.
Chemical References
  • Antineoplastic Agents
  • Biomarkers
  • PPAR gamma
  • Thiazolidinediones
  • efatutazone
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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