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Lapatinib and Bevacizumab for Metastatic Breast Cancer

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT00444535
First received: March 6, 2007
Last updated: July 30, 2013
Last verified: July 2013
  Purpose

This study will examine the efficacy and safety of lapatinib and bevacizumab in patients with ErbB2-overexpressing breast cancer.


Condition Intervention Phase
Neoplasms, Breast
Drug: lapatinib
Drug: bevacizumab
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:
  • Percentage of Participants Reaching Week 12 Without Disease Progression [ Time Frame: Week 12 ] [ Designated as safety issue: No ]
    The progression-free survival rate was evaluated by the investigator after 12 weeks of treatment and was defined as the number of participants with no evidence of disease progression (20% increase in sum of longest diameters, new lesions, or symptomatic progression) per Response Evaluation Criteria in Solid Tumors (RECIST) or death from any cause for a minimum of 84 days (12 weeks).


Secondary Outcome Measures:
  • Overall Response [ Time Frame: Week 6 through End of Study (until end of treatment; end of treatment for each participant was dependent on when the participant withdrew from study therapy due to disease progression, an adverse event, or participant decision) ] [ Designated as safety issue: No ]
    The percentage of participants with measurable disease with a best response of partial response (PR, 30% reduction from baseline sum of longest diameters or complete resolution of target lesions and no progression in non-target lesions) or complete response (CR, complete resolution of lesions observed at baseline) per RECIST was measured. The first assessment of overall response was at Week6; however, the participants were assessed for response until treatment ended.

  • Clinical Benefit [ Time Frame: Baseline through End of Study (end of treatment; end of treatment for each participant was dependent on when the participant withdrew from study therapy due to disease progression, an adverse event, or participant decision) ] [ Designated as safety issue: No ]
    Clinical benefit is defined as defined as the percentage of participants with evidence of a confirmed CR (complete resolution of lesions observed at baseline) or PR (30% reduction from baseline sum of longest diameters or complete resolution of target lesions and no progression in non-target lesions) at any time or stable disease (insufficient response to qualify for CR or PR, and insufficient increase in tumor burden to qualify for progressive disease [20% increase in sum of longest diameters, new lesions, or symptomatic progression]) for at least 24 weeks per RECIST.

  • Progression-free Survival [ Time Frame: Baseline through End of Study (end of treatment; end of treatment for each participant was dependent on when the participant withdrew from study therapy due to disease progression, an adverse event, or participant decision) ] [ Designated as safety issue: No ]
    Progression-free survival (PFS) = time from treatment start date until the first documented sign of disease progression, as defined by the investigator, or death due to any cause. For participants who did not progress or die at the time of reporting, PFS data were censored at the time of the last radiological assessment.


Enrollment: 52
Study Start Date: February 2007
Estimated Study Completion Date: December 2013
Primary Completion Date: July 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Oral lapatinib tablets in combination with IV bevacizumab
1500 mg oral lapatinib (once daily) plus 10 mg/kg intravenous bevacizumab (every two weeks)
Drug: lapatinib
1500 mg oral lapatinib (once daily)
Other Name: Tykerb/Tyverb
Drug: bevacizumab
10 mg/kg intravenous bevacizumab (every two weeks)

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00444535

Locations
United States, California
GSK Investigational Site
San Francisco, California, United States, 94115
Sponsors and Collaborators
GlaxoSmithKline
Investigators
Study Director: GSK Clinical Trials GlaxoSmithKline
  More Information

No publications provided by GlaxoSmithKline

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT00444535     History of Changes
Other Study ID Numbers: EGF103890
Study First Received: March 6, 2007
Results First Received: July 9, 2009
Last Updated: July 30, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by GlaxoSmithKline:
VEGF
Tyrosine kinase
ErbB2
Her2-neu
metastatic breast cancer
EGFR
ErbB1
bevacizumab
lapatinib

Additional relevant MeSH terms:
Breast Neoplasms
Breast Diseases
Neoplasms
Neoplasms by Site
Skin Diseases
Bevacizumab
Lapatinib
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Antineoplastic Agents
Enzyme Inhibitors
Growth Inhibitors
Growth Substances
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs
Protein Kinase Inhibitors
Therapeutic Uses

ClinicalTrials.gov processed this record on November 20, 2014