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Drug Use Investigation for TYKERB Tablet (All Case Investigation)

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT01332396
First received: April 7, 2011
Last updated: January 24, 2013
Last verified: January 2013
History of Changes
  Purpose

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.


Condition Intervention
Cancer
 Drug: Lapatinib

Study Type: Observational
Official Title: Drug Use Investigation for TYKERB Tablet (All Case Investigation)

Resource links provided by NLM:

MedlinePlus related topics: Cancer
U.S. FDA Resources

Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:
  • The incidence of adverse events in Japanese patients treated with TYKERB based on prescribing information under the conditions of general clinical practice [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 3000
Study Start Date: June 2009
Estimated Study Completion Date: July 2016
Estimated Primary Completion Date: March 2013 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Patients prescribed TYKERB
Patients with HER2 overexpressing inoperable or recurrent breast cancer
 Drug: Lapatinib

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

All patients who have "HER2 overexpressing inoperable or recurrent breast cancer" and have received TYKERB for the first time

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01332396

Sponsors and Collaborators
GlaxoSmithKline
Investigators
Study Director: GSK Clinical Trials GlaxoSmithKline
  More Information

No publications provided

Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT01332396     History of Changes
Other Study ID Numbers: 113092
Study First Received: April 7, 2011
Last Updated: January 24, 2013
Health Authority: Japan: Pharmaceuticals and Medical Devices Agency

Additional relevant MeSH terms:
Lapatinib
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
 Pharmacologic Actions
Antineoplastic Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on June 18, 2013