Last updated: 11/07/2018 16:20:13
This product has been transferred to Novartis. GSK Clinical Study Register is no longer maintained for this study. The most up to date information is available on clinicaltrials.gov.

Phase II Study of Lapatinib and Bevacizumab for Metastatic Breast Cancer

GSK study ID
EGF103890
See study documents
Clinicaltrials.gov ID
NCT00444535
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
No longer a GSK study
No longer a GSK study
Overview
Eligibility
Locations
Study documents
Results summary
Plain language summaries
Additional information

Trial overview

Official title: A Phase II, Open-Label Study of the Clinical Activity, Safety, and Tolerability of Lapatinib in Combination with Bevacizumab in Subjects with Advanced or Metastatic ErbB2-Overexpressing Breast Cancer
Trial description: This study will examine the efficacy and safety of lapatinib and bevacizumab in patients with ErbB2-overexpressing breast cancer.
Primary purpose:
Treatment
Trial design:
Single Group Assignment
Masking:
None (Open Label)
Allocation:
Randomized
Primary outcomes:

Progression-free survival

Timeframe: 12 weeks of study treatment

Secondary outcomes:

Safety Overall, Tumor Response Rate, Clinical Benefit Rate, Time to Response, Duration of Response, Progression-free survival, Changes in biomarker signals

Timeframe: Beginning of treatment until treatment end

Interventions:
  • Drug: bevacizumab
  • Drug: lapatinib
    • Enrollment:
    52
    Primary completion date:
    2008-22-07
    Observational study model:
    Not applicable
    Time perspective:
    Not applicable
    Clinical publications:
    Hope S. Rugo, A. Jo Chien, Sandra X. Franco, Alison M. Stopeck, Alexa Glencer, Soumi Lahiri, Michael C. Arbushites, Janet Scott, John W. Park, Cliff Hudis, Ben Nulsen, Maura N. Dickler. A Phase II Study of Lapatinib and Bevacizumab as Treatment for HER2-Overexpressing Metastatic Breast Cancer . Breast Cancer Res Treat. 2010;
    Medical condition
    Neoplasms, Breast
    Product
    lapatinib
    Collaborators
    Not applicable
    Study date(s)
    February 2007 to June 2016
    Type
    Interventional
    Phase
    2/3

    Participation criteria

    Sex
    Female
    Age
    18+ years
    Accepts healthy volunteers
    none
    • Females that are at least 18 years of age.
    • Women of childbearing potential must have a negative serum pregnancy test at screening.
    • Pregnancy
    • Unstable or symptomatic CNS metastases
    Inclusion and exclusion criteria
    Inclusion criteria:
    • Females that are at least 18 years of age.
    • Women of childbearing potential must have a negative serum pregnancy test at screening.
    • Documented evidence of HER2-overexpressing unresectable or metastatic breast cancer. Disease may/may not have been treated in metastatic setting.
    • Subjects are permitted (but not required) to have previously-treated brain metastases that are stable and asymptomatic.
    • Adequate hepatic, renal and cardiac function
    • ECOG score 0-1 and a life expectancy of at least 12 weeks.
    • Able to swallow oral medication
    • Signed informed consent
    Exclusion criteria:
    • Pregnancy
    • Unstable or symptomatic CNS metastases
    • Major surgery within 28 days of enrollment (minor surgery within 7 days).
    • Prior anti-cancer treatment within 14 days of enrollment, or unresolved treatment-related toxicities.
    • A serious non-healing wound, ulcer, or bone fracture at baseline.
    • Class II, III or IV heart failure as defined by the NYHA functional classification system
    • History of significant vascular disease, arterial thrombosis, unstable INR, hypertensive crisis, or uncontrolled hypertension.
    • History of myocardial infarction, stenting procedure, or angioplasty within 6 months of enrollment.
    • History of abdominal fistulae, gastrointestinal perforation, or intra-abdominal abscess within 6 months of enrollment.
    • History of malabsorption syndrome, ulcerative colitis, or bowel obstruction.
    • Proteinuria
    • Requires concurrent anti-cancer treatment or investigational treatment.
    • Known hypersensitivity to either study medication
    • Received investigational treatment within 28 days or 5 half-lives, whichever is longer
    • Concurrent disease or circumstances that would lead the investigator would consider the subject an inappropriate candidate for the study
    • Requires medication that has been excluded during study participation

    Trial location(s)

    This study does not involve prospective enrollment of participants.

    Study documents

    Clinical study report
    Available language(s): English
    Download document(s)
    Scientific result summary
    Available language(s): English
    Download document(s)

    If you wish to request for full study report, please contact - [email protected]

    Results overview

    Refer to study documents

    Recruitment status
    No longer a GSK study
    Actual primary completion date
    2008-22-07
    Actual study completion date
    Not applicable

    Plain language summaries

    Plain language summaries of clinical trial results for Phase 2-4 clinical trials that were initiated on or after January 2022 will be posted by GSK within one year following study completion.

    Additional information about the trial

    Additional information
    Not applicable
    Participate in clinical trial
    Access to clinical trial data by researchers
    Visit website