NCT00928330

Trastuzumab and Trastuzumab-MCC-DM1 Administered Intravenously and GDC-0941 Administered Orally to Patients With HER2-Positive Metastatic Breast Cancer Who Have Progressed on Previous Trastuzumab-Based Therapy

A Phase Ib, Open-Label Study of the Safety, Tolerability, Pharmacokinetics, and Activity of Trastuzumab and Trastuzumab-MCC-DM1 Administered Intravenously and GDC-0941 Administered Orally to Patients With HER2-Positive Metastatic Breast Cancer Who Have Progressed on Previous Trastuzumab-Based Therapy

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 57 (actual)
• Sponsor: Genentech, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This multicenter, Phase Ib study is an open label, dose escalation, three-arm study evaluating the safety, tolerability, pharmacokinetics, and activity of oral (PO) GDC 0941 administered in combination with either intravenous (IV) infusion of T-DM1 or IV infusion of trastuzumab.

Conditions

• Metastatic Breast Cancer

Interventions

Type	Name	Description
DRUG	GDC-0941	Oral repeating dose
DRUG	Trastuzumab	Intravenous repeating dose
DRUG	trastuzumab-MCC-DM1	Intravenous repeating dose

Timeline

• Start date: 2009-07-01
• Primary completion: 2014-01-01
• Completion: 2014-01-01
• First posted: 2009-06-25
• Last updated: 2016-11-02

Locations

3 sites across 1 country: United States