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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.

Tracking Information
First Submitted Date  ICMJE June 23, 2009
First Posted Date  ICMJE June 25, 2009
Last Update Posted Date November 2, 2016
Study Start Date  ICMJE July 2009
Actual Primary Completion Date January 2014   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 24, 2009)
  • 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 ]
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT00928330 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: June 11, 2012)
  • 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 ]
Original Secondary Outcome Measures  ICMJE
 (submitted: June 24, 2009)
  • 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 ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE 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
Official Title  ICMJE 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
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Metastatic Breast Cancer
Intervention  ICMJE
  • Drug: GDC-0941
    Oral repeating dose
  • Drug: Trastuzumab
    Intravenous repeating dose
  • Drug: trastuzumab-MCC-DM1
    Intravenous repeating dose
Study Arms  ICMJE
  • 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
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: June 11, 2012)
57
Original Estimated Enrollment  ICMJE
 (submitted: June 24, 2009)
9
Actual Study Completion Date  ICMJE January 2014
Actual Primary Completion Date January 2014   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries United Kingdom
 
Administrative Information
NCT Number  ICMJE NCT00928330
Other Study ID Numbers  ICMJE GDC4627g
GO01302 ( Other Identifier: Hoffmann-La Roche )
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Genentech, Inc.
Study Sponsor  ICMJE Genentech, Inc.
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Clinical Trials Genentech, Inc.
PRS Account Genentech, Inc.
Verification Date November 2016

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