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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


Phase 2
18 Years
N/A
Open (Enrolling)
Female
Neoplasms, Breast

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Trial Information

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

Inclusion 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

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

Percentage of Participants Reaching Week 12 Without Disease Progression

Outcome Description:

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).

Outcome Time Frame:

Week 12

Safety Issue:

No

Principal Investigator

GSK Clinical Trials

Investigator Role:

Study Director

Investigator Affiliation:

GlaxoSmithKline

Authority:

United States: Food and Drug Administration

Study ID:

EGF103890

NCT ID:

NCT00444535

Start Date:

February 2007

Completion Date:

May 2013

Related Keywords:

  • Neoplasms, Breast
  • VEGF
  • Tyrosine kinase
  • ErbB2
  • Her2-neu
  • metastatic breast cancer
  • EGFR
  • ErbB1
  • bevacizumab
  • lapatinib
  • Breast Neoplasms
  • Neoplasms

Name

Location

GSK Investigational SitePhoenix, Arizona  85013 - 4496
GSK Investigational SiteBakersfield, California  93309
GSK Investigational SiteGainesville, Florida  32610
GSK Investigational SiteNew York, New York  10021