A Phase 1/2 Study of HKI-272 (Neratinib) in Combination With Paclitaxel (Taxol) in Subjects With Solid Tumors and Breast Cancer

Phase 1/2 Completed 110 enrolled Puma Biotechnology, Inc.

Non-randomizedParallel-groupOpen-labelTreatment

Summary

The purpose of this study is to learn whether it is safe and effective to administer HKI-272 (neratinib) in combination with paclitaxel in patients with breast cancer.

Timeline

Start: 2007-09-11
Primary completion: 2011-05
Completion: 2018-02-07

Publications

Chow LW, Xu B, Gupta S, Freyman A, Zhao Y, Abbas R, Vo Van ML, Bondarenko I. Combination neratinib (HKI-272) and paclitaxel therapy in patients with HER2-positive metastatic breast cancer. Br J Cancer. 2013 May 28;108(10):1985-93. doi: 10.1038/bjc.2013.178. Epub 2013 Apr 30.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Neratinib	Small molecule	160 mg	Oral
Subject	Neratinib	Small molecule	240 mg	Oral
Background	Paclitaxel	Small molecule	80 mg/m2	Intravenous

A Phase 1/2 Study of HKI-272 (Neratinib) in Combination With Paclitaxel (Taxol) in Subjects With Solid Tumors and Breast Cancer

Summary

Timeline

Publications

Drugs

Indications