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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

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ClinicalTrials.gov Identifier: NCT00928330
Recruitment Status : Completed
First Posted : June 25, 2009
Last Update Posted : November 2, 2016
Sponsor:
Information provided by (Responsible Party):
Genentech, Inc.

June 23, 2009
June 25, 2009
November 2, 2016
July 2009
January 2014   (Final data collection date for primary outcome measure)
  • Changes in cardiac function [ Time Frame: Through study completion or early study discontinuation ]
  • Changes in vital signs, physical findings, and clinical laboratory results during and following administration of study drugs that result in dose modification, dose delay, or discontinuation of T-DM1 and/or GDC 0941 [ Time Frame: Through study completion or early study discontinuation ]
  • Incidence, nature, and severity of adverse events [ Time Frame: Through study completion or early study discontinuation ]
Same as current
Complete list of historical versions of study NCT00928330 on ClinicalTrials.gov Archive Site
  • PK parameters of T-DM1 and GDC-0941 (total exposure, maximum serum concentration, and minimum concentration) [ Time Frame: Through study completion or early study discontinuation ]
  • Progression-free survival (PFS) [ Time Frame: From study treatment initiation to the first occurrence of disease progression or death on study ]
  • Objective response based on investigator assessment [ Time Frame: Confirmed response >/= 4 weeks after initial documentation of response ]
  • Duration of response [ Time Frame: Time from initial complete or partial response to the time of disease progression or death on study ]
  • PK parameters of T-DM1 and GDC-0941 (total exposure, maximum serum concentration, and minimum concentration) [ Time Frame: Through study completion or early study discontinuation ]
  • Progression-free survival (PFS) [ Time Frame: From study treatment initiation to the first occurrence of disease progression or death on study ]
  • Objective response based on investigator assessment [ Time Frame: Confirmed response ≥ 4 weeks after initial documentation of response ]
  • Duration of response [ Time Frame: Time from initial complete or partial response to the time of disease progression or death on study ]
Not Provided
Not Provided
 
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
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.
Not Provided
Interventional
Phase 1
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Metastatic Breast Cancer
  • Drug: GDC-0941
    Oral repeating dose
  • Drug: Trastuzumab
    Intravenous repeating dose
  • Drug: trastuzumab-MCC-DM1
    Intravenous repeating dose
  • Experimental: A
    Interventions:
    • Drug: GDC-0941
    • Drug: trastuzumab-MCC-DM1
  • Experimental: B
    Interventions:
    • Drug: GDC-0941
    • Drug: trastuzumab-MCC-DM1
  • Experimental: C
    Interventions:
    • Drug: GDC-0941
    • Drug: Trastuzumab
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
57
9
January 2014
January 2014   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
United States
United Kingdom
 
NCT00928330
GDC4627g
GO01302 ( Other Identifier: Hoffmann-La Roche )
Not Provided
Not Provided
Not Provided
Genentech, Inc.
Genentech, Inc.
Not Provided
Study Director: Clinical Trials Genentech, Inc.
Genentech, Inc.
November 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP