Last updated: 11/03/2018 16:44:55
This product has been transferred to Novartis. GSK Clinical Study Register is no longer maintained for this study.
Lapatinib Post Marketing Surveillance StudyLapatinib PMS
GSK study ID
114498
Clinicaltrials.gov ID
Not applicable
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 post-marketing surveillance study of lapatinib ditosylate in the treatment of Filipino patients with Advanced or Metastatic Breast Cancer (MBC)
Trial description: The study is a regulatory mandated post marketing surveillance study for lapatinib ditosylate.
Primary purpose:
Not applicable
Trial design:
Not applicable
Masking:
Not applicable
Allocation:
Not applicable
Primary outcomes:
adverse event reactions from patients receiving lapatinib
Timeframe: 12 months
Secondary outcomes:
none
Timeframe: none
Interventions:
Drug: Tykerb
Enrollment:
3000
Observational study model:
Other
Primary completion date:
Not applicable
Time perspective:
Prospective
Clinical publications:
Not applicable
Medical condition
Cancer, Neoplasms
Product
lapatinib
Collaborators
Not applicable
Study date(s)
February 2011 to September 2015
Type
Observational
Phase
4
Participation criteria
Sex
Female
Age
18 - 85 Year
Accepts healthy volunteers
none
- 1. Adult patients (including elderly) with clinically diagnosed Advanced or Metastatic Breast Cancer (MBC),
- 2. Patients must give written informed consent to take part in the study.
- 1. Patients with known hypersensitivity to lapatinib ditosylate or any component of the preparation.
- 2. Patients with Hepatic Impairment (aspartate aminotransferase (AST) and alanine aminotransferase (ALT) more than the three times the upper limit of normal range (ULN)
Inclusion and exclusion criteria
Inclusion criteria:
- 1. Adult patients (including elderly) with clinically diagnosed Advanced or Metastatic Breast Cancer (MBC), 2. Patients must give written informed consent to take part in the study. 3. As per recommendation of lapatinib ditosylate prescribing information.
Exclusion criteria:
- 1. Patients with known hypersensitivity to lapatinib ditosylate or any component of the preparation. 2. Patients with Hepatic Impairment (aspartate aminotransferase (AST) and alanine aminotransferase (ALT) more than the three times the upper limit of normal range (ULN) 3. Patients with Cardiac dysfunction (left ventricular ejection fraction (LVEF) below the lower limits of the institutional range as measured by ECHO)
Trial location(s)
No location data available.
Study documents
No study documents available.
Results overview
No study documents available
Recruitment status
No longer a GSK study
Actual primary completion date
Not applicable
Actual study completion date
Not applicable
Plain language summaries
Not applicable. GSK’s transparency policy provides for Plain Language Summaries for Interventional studies.
Additional information about the trial
Not applicable
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