A Study Of The Safety And Tolerability Of HKI-272 Administered Orally To Japanese Subjects With Advanced Solid Tumors

Phase 1 Completed 21 enrolled Puma Biotechnology, Inc.

Non-randomizedSequentialOpen-labelTreatment

Summary

The purpose of this study is to assess the tolerability and safety of HKI-272, and to determine the maximum dose that can safety be given. The secondary purpose of this study is to determine how the body uses and gets rid of HKI-272 and to assess whether HKI-272 is effective for the treatment of advanced solid tumors.

Timeline

Start: 2006-11
Primary completion: 2009-03
Completion: 2009-03

Publications

Ito Y, Suenaga M, Hatake K, Takahashi S, Yokoyama M, Onozawa Y, Yamazaki K, Hironaka S, Hashigami K, Hasegawa H, Takenaka N, Boku N. Safety, efficacy and pharmacokinetics of neratinib (HKI-272) in Japanese patients with advanced solid tumors: a Phase 1 dose-escalation study. Jpn J Clin Oncol. 2012 Apr;42(4):278-86. doi: 10.1093/jjco/hys012. Epub 2012 Feb 27.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Neratinib	Small molecule	80 mg	Oral
Subject	Neratinib	Small molecule	160 mg	Oral
Subject	Neratinib	Small molecule	240 mg	Oral
Subject	Neratinib	Small molecule	320 mg	Oral

A Study Of The Safety And Tolerability Of HKI-272 Administered Orally To Japanese Subjects With Advanced Solid Tumors

Summary

Timeline

Publications

Drugs

Indications