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 GSK Clinical Study Register is no longer maintained for this study.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
Clinicaltrials.gov ID
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
No longer a GSK study
No longer a GSK study
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
Observational study model:
Not applicable
Primary completion date:
2008-22-07
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)
No location data available.
Study documents
Clinical study report
Available language(s): English
Scientific result summary
Available language(s): English
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
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Access to clinical trial data by researchers
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