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

NCT ID: NCT00928330

Last Updated: 2016-11-02

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 57 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-07-31
• Study Completion Date: 2014-01-31

Brief 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

Keywords

TDM-1; HER2; HER2+; HER2+ Breast Cancer; HER-2; MBC; Trastuzumab emtansine

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

A

Group Type: EXPERIMENTAL

GDC-0941

Intervention Type: DRUG

Oral repeating dose

trastuzumab-MCC-DM1

Intervention Type: DRUG

Intravenous repeating dose

B

Group Type: EXPERIMENTAL

GDC-0941

Intervention Type: DRUG

Oral repeating dose

trastuzumab-MCC-DM1

Intervention Type: DRUG

Intravenous repeating dose

C

Group Type: EXPERIMENTAL

GDC-0941

Intervention Type: DRUG

Oral repeating dose

Trastuzumab

Intervention Type: DRUG

Intravenous repeating dose

Interventions

GDC-0941

Oral repeating dose

Intervention Type: DRUG

Trastuzumab

Intravenous repeating dose

Intervention Type: DRUG

trastuzumab-MCC-DM1

Intravenous repeating dose

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• Histologically documented locally advanced or metastatic breast cancer that has progressed on at least one trastuzumab-based regimen in the metastatic or locally advanced setting
• HER2-positive disease documented by one of the following results using FDA-approved testing methods: FISH-positive, chromogenic in situ hybridization (CISH)-positive, or IHC 3 + by local laboratory assessment
• Life expectancy >= 90 days
• Agreement to use an effective form of contraception for the duration of the study

Exclusion Criteria

• History of Grade >= 3 hypersensitivity reaction to trastuzumab, or Grade >= 1 with the most recent trastuzumab infusion before study entry, or continued requirement for prolonged trastuzumab infusions to prevent hypersensitivity reactions
• History of intolerance to trastuzumab and/or adverse events related to trastuzumab that resulted in trastuzumab being permanently discontinued
• Prior anti-cancer therapy (e.g., biologic or other targeted therapy, chemotherapy, hormonal therapy) within 2 weeks prior to Day 1
• Prior investigational anti-cancer therapy within 4 weeks prior to Day 1
• Grade >= 2 peripheral neuropathy
• History of Grade >= 3 hyperglycemia (fasting)
• History of Type 1 or Type 2 diabetes requiring daily medication
• History of clinically significant cardiac or pulmonary dysfunction
• History of malabsorption syndrome or other condition that would interfere with enteral absorption
• Clinically significant history of liver disease, including cirrhosis, current alcohol abuse, or current known active infection with HIV, hepatitis B virus, or hepatitis C virus
• Any condition requiring anticoagulants, such as warfarin, heparin, or thrombolytic agents
• Any condition requiring > 2 grams of acetaminophen daily
• Need for current chronic corticosteroid therapy
• Pregnancy, lactation, or breast-feeding
• Current severe, uncontrolled systemic disease (e.g., clinically significant cardiovascular, pulmonary, or metabolic disease)
• Major surgical procedure or significant traumatic injury within 28 days prior to Day 1, or anticipation of the need for major surgery during the course of study treatment
• Symptomatic hypercalcemia requiring continued use of bisphosphonate therapy
• Known brain metastases that are untreated, symptomatic, or require therapy to control symptoms

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Genentech, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Clinical Trials

Role: STUDY_DIRECTOR

Genentech, Inc.

Locations

Indianapolis, Indiana, United States

Baltimore, Maryland, United States

Boston, Massachusetts, United States

Countries

United Kingdom; United States

Other Identifiers

GO01302

Identifier Type: OTHER

Identifier Source: secondary_id

GDC4627g

Identifier Type: -

Identifier Source: org_study_id