A Study Of PF-00299804 In Patients In Japan With Advanced Malignant Solid Tumors

Phase 1 Completed 13 enrolled Pfizer

Non-randomizedSingle-groupOpen-labelTreatment

Summary

To evaluate safety and tolerability of PF-00299804 in Japanese patients with advanced malignant solid tumors at doses up to the clinically recommended phase 2 dose in non-Japanese studies.

Timeline

Start: 2008-11
Primary completion: 2011-03
Completion: 2011-03

Publications

Takahashi T, Boku N, Murakami H, Naito T, Tsuya A, Nakamura Y, Ono A, Machida N, Yamazaki K, Watanabe J, Ruiz-Garcia A, Imai K, Ohki E, Yamamoto N. Phase I and pharmacokinetic study of dacomitinib (PF-00299804), an oral irreversible, small molecule inhibitor of human epidermal growth factor receptor-1, -2, and -4 tyrosine kinases, in Japanese patients with advanced solid tumors. Invest New Drugs. 2012 Dec;30(6):2352-63. doi: 10.1007/s10637-011-9789-z. Epub 2012 Jan 17.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	DACOMITINIB ANHYDROUS	Small molecule	15 mg	Oral
Subject	DACOMITINIB ANHYDROUS	Small molecule	30 mg	Oral
Subject	DACOMITINIB ANHYDROUS	Small molecule	45 mg	Oral

A Study Of PF-00299804 In Patients In Japan With Advanced Malignant Solid Tumors

Summary

Timeline

Publications

Drugs

Indications