Study Assessing Safety and Tolerability of AZD8931 Alone or in Combination With Paclitaxel in Japanese Patients.

Phase 1 Completed 17 enrolled AstraZeneca

RandomizedSingle-groupOpen-labelTreatment

Summary

The main purpose of this study is to determine if AZD8931 can be safely administered in Japanese patients alone and in combination with weekly paclitaxel. The study will be conducted in two parts: a monotherapy and a combination part, where safe doses of study treatment will be determined.

Timeline

Start: 2009-10
Primary completion: 2012-04
Completion: 2012-04

Publications

Kurata T, Tsurutani J, Fujisaka Y, Okamoto W, Hayashi H, Kawakami H, Shin E, Hayashi N, Nakagawa K. Inhibition of EGFR, HER2 and HER3 signaling with AZD8931 alone and in combination with paclitaxel: phase i study in Japanese patients with advanced solid malignancies and advanced breast cancer. Invest New Drugs. 2014 Oct;32(5):946-54. doi: 10.1007/s10637-014-0112-7. Epub 2014 May 31.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	SAPITINIB	Small molecule	40 mg	Oral
Subject	SAPITINIB	Small molecule	60 mg	Oral
Subject	SAPITINIB	Small molecule	80 mg	Oral
Background	Paclitaxel	Small molecule	90 mg/m2	Intravenous

Study Assessing Safety and Tolerability of AZD8931 Alone or in Combination With Paclitaxel in Japanese Patients.

Summary

Timeline

Publications

Drugs

Indications