Last updated: 11/03/2018 14:12:52
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 GSK Clinical Study Register is no longer maintained for this study.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.
Tykerb ALL
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: Drug Use Investigation for TYKERB tablet (All case investigation)
Trial description: Data on the safety and efficacy of TYKERB shall be collected from the patients in order to grasp the actual conditions of post-marketing use and assess background information on the patients.
Primary purpose:
Not applicable
Trial design:
Not applicable
Masking:
Not applicable
Allocation:
Not applicable
Primary outcomes:
The incidence of adverse events in Japanese patients treated with TYKERB based on prescribing information under the conditions of general clinical practice
Timeframe: 1 year
Secondary outcomes:
Not applicable
Interventions:
Drug: Lapatinib
Enrollment:
3000
Observational study model:
Other
Primary completion date:
Not applicable
Time perspective:
Other
Clinical publications:
Not applicable
Medical condition
Cancer, Neoplasms
Product
lapatinib
Collaborators
Not applicable
Study date(s)
June 2009 to April 2016
Type
Observational
Phase
Not applicable
Participation criteria
Sex
Female & Male
Age
Not applicable
Accepts healthy volunteers
none
- Patients with HER2 overexpressing inoperable or recurrent breast cancer
- Patients with hypersensitivity to lapatinib or any components
- Pregnant women and women suspected of being pregnant
Inclusion and exclusion criteria
Inclusion criteria:
- Patients with HER2 overexpressing inoperable or recurrent breast cancer
Exclusion criteria:
- Patients with hypersensitivity to lapatinib or any components
- Pregnant women and women suspected of being pregnant
Trial location(s)
No location data available.
Study documents
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
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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